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Amanda D. Rice, PhD, Evette D’Avy Reed, PT, Kimberly Patterson, PTA, LMT, Belinda F. Wurn, PT, and Lawrence J. Wurn, LMT

Decreasing pain and improving function and quality of life are important topics for patients who refuse, or are not candidates for, traditional medical interventions, and those at the end stages of disease. Patients with inoperable, metastatic bowel carcinoma who experience pain and small bowel obstruction (SBO) as a result of adhesions are a subset of these patients. The standard treatment, adhesion and/or resection surgery, followed by post-surgical medications to prevent infection and decrease pain, may not be ideal in end-stage cancer patients. We treated such a patient using manual soft tissue physical therapy with the goals of decreasing her pain and alleviating symptoms of bowel obstruction secondary to adhesions successfully, using a protocol we developed initially to open fallopian tubes that were blocked by adhesions.

The patient was a 61-year-old married woman with a history of multiple abdominopelvic surgeries over the last 12 years, including hysterectomy, ileostomy, and ileostomy reversal with chemotherapy and radiation for treatment of stage IIIB ovarian/peritoneal carcinoma. She experienced SBO episodes every 2-3 months and had five adhesiolysis and/or resection surgeries to attempt to repair the bowel. Because she had undergone a recent exploratory laparoscopy that revealed metastasis to the omentum, her physicians were reluctant to perform any further surgeries, and the patient requested no more surgical interventions.

She was unable to eat or drink, so a peripherally inserted central catheter (PICC line) was placed, and she received total parenteral nutrition (TPN) daily. She experienced chronic pain associated with the SBOs at a level of 4-5/10 that increased throughout the day with movement. The patient was undergoing chemotherapy and medicated with Nexium 40mg qd, Compazine 10mg prn, Zofran 4mg prn, Ativan 1mg qd, multivitamin bid, Vitamin D 2000mg qd, Co-Enzyme Q10 qd, and Dilaudid prn for pain. Her goals were to relieve the abdominal pain, decrease SBO incidents, eat a normal diet, and travel.

The patient underwent 29 hours of manual soft tissue physical therapy 1–6 over six months, focused on detaching the abdominal adhesions, and was instructed in self-treatment techniques. At initial evaluation, she said she must reside near a hospital, due to the PICC line and recurring SBOs.

She demonstrated improvement through the duration of therapy with significant pain decrease and functional increase. By discharge, her physician had removed the PICC lines because she had returned to eating a normal diet (including hamburger). She was then able to travel overseas with her husband, a significant increase in her quality of life.

Alleviating pain and dysfunction, and improving life quality are challenging goals in patients with inoperable gastrointestinal cancer. Here we report a successful nonsurgical treatment for abdominal adhesions, pain, and dysfunction in a terminally ill patient. Before therapy, she lived with recurring SBOs, repeated surgeries, pain, and dysfunction. Her only nutrition was intravenous TPN. After undergoing this manual soft tissue physical therapy, she was able to eat a normal diet and participate in activities she desired.

References

1. Alternative Medicine and Rehabilitation. Wainapel SF, Fast A (eds). Demos Medical Publishing, 2003. Available from: http://www.ncbi.nlm.nih.gov/books/NBK11183/ (Last accessed September 4, 2012.)
2. Principles of manual medicine, 2e. Greenman PE. Williams & Wilkins, Baltimore, Maryland, 1996.
3. Brown JS. Rehabilitation of Soft Tissue Injuries in the 1990s. Dynamic Chiropr 1991;9(21):1–3.
4. Wurn BF, Wurn LJ, King CR, Heuer M a, Roscow AS, Hornberger K, et al: Treating fallopian tube occlusion with manual pelvic physical therapy. Altern Ther Health Med 2008;14(1):18–23.
5. Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, et al: Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed 2004;6(2):51.
6. Wurn BF, Wurn LJ, Patterson K, King CR, Scharf ES: Decreasing dyspareunia and dysmenorrhea in women with endometriosis via manual physical therapy: Results from two independent studies. J Endometriosis 2011;3(4):188–96.

by Amanda D. Rice, Richard King, Evette D’Avy Reed, Kimberley Patterson, Belinda F. Wurn, and Lawrence J. Wurn ^*

Clear Passage Physical Therapy, 4421 NW 39th Ave, Ste 2-2, Gainesville, FL 32606, USA^*

Author to whom correspondence should be addressed.

J. Clin. Med. 2013, 2(1), 1-12; https://doi.org/10.3390/jcm2010001

Submission received: 28 December 2012 / Revised: 14 January 2013 / Accepted: 22 January 2013 / Published: 4 February 2013

Abstract

Background: Adhesion formation is a widely acknowledged risk following abdominal or pelvic surgery. Adhesions in the abdomen or pelvis can cause or contribute to partial or total small bowel obstruction (SBO). These adhesions deter or prevent the passage of nutrients through the digestive tract and may bind the bowel to the peritoneum or other organs. Small bowel obstructions can quickly become life-threatening, requiring immediate surgery to resect the bowel or lyse any adhesions the surgeon can safely access. Bowel repair is an invasive surgery, with risks including bowel rupture, infection, and peritonitis. An additional risk includes the formation of new adhesions during the healing process, creating the potential for subsequent adhesiolysis or SBO surgeries. Objective: Report the use of manual soft tissue physical therapy for the reversal of adhesion-related partial SBOs, and create an initial inquiry into the possibility of nonsurgical lysis of adhesions. Case Reports: Two patients presenting with SBO symptoms due to abdominal adhesions secondary to abdominal and pelvic surgery were treated with manual soft tissue physical therapy focused on decreasing adhesions. Conclusions: Successful treatment with resolution of symptom presentation of partial SBO and sustained results were observed in both patients treated.

Keywords: 

small bowel obstruction; SBO treatment; manual physical therapy; surgery alternative

1. Introduction

Peritoneal adhesions are a major contributory factor in the development of small bowel obstruction (SBO) worldwide and are a common post-abdominopelvic surgical occurrence. The literature indicates that 50% to 100% of patients develop adhesions after any abdominal/pelvic surgery [1,2,3,4,5]. A large analysis of the incidence of adhesions, which was performed in the 1990’s, found that 35% of all open abdominal or pelvic surgery patients were readmitted to the hospital more than twice to treat post-surgical adhesions within 10 years following their initial surgery, with 22% of readmissions requiring surgery occurring within the first year. The report noted “readmissions continued steadily throughout the 10-year period” of the study [6].

The severity of post-surgical adhesions is challenging to control, as they are influenced by factors attributed to both the patient and the surgical procedure. Despite numerous clinical trials to assess the validity of various strategies, agents, and surgical meshes to prevent adhesion formation, the debate continues with no protocol yet shown to prevent the generation of adhesions as the body heals from surgical intervention [2].

Adhesions commonly form secondary to the normal wound healing process. They form as a result of fibrin formation at the site of the surgical wound, which provides the matrix for fibroblasts to migrate and generate a collagen extracellular matrix (ECM) [2]. It is this ECM and its associated cells that ultimately become the adhesions. Although it is the body’s response to surgery and the healing process in the presence of increased levels of inflammatory cytokines that promotes the formation of adhesions, it is clear that adhesions are not merely non-functional scar tissue. It has been found that mature adhesions are complex tissues with ingrowths of capillaries, adipose tissue, smooth muscle, and nerve fibers that are typically found in complex regenerating structures [7]. Further, adhesion formation is not always limited to the geography of the locally traumatized tissues. Some patients form additional adhesions at locations proximal or distal to the surgical site. It should be noted that surgery is not the only cause of adhesion formation and that all healing, including surgery, physical trauma, infection, and/or inflammation, has the ability to form adhesions in the body [8].

The standard current treatment for SBO due to adhesions that cannot be resolved by gastric decompression or bowel rest is surgery to lyse the adhesions (adhesiolysis), thereby resolving the obstruction. In some cases, SBO surgery also involves cutting and removing adhered, damaged, or necrosed sections of the bowel, followed by resection of the remaining bowel ends. Utilizing surgery to lyse the adhesions caused by an initial surgery and/or to resect the bowel often causes the formation of new adhesions as a part of the wound healing process. This can create and perpetuate an ongoing cycle of healing and adhesion formation, obstruction surgery to remove the offending adhesions or resect the bowel, followed by new healing and new adhesion formation, and so on. In cases of SBO, this cycle can mean repeat hospitalizations to treat a life-threatening condition. The risk of infection due to spillage of bowel contents into the interstitial spaces of the abdomen is not an insignificant complication following bowel resection. Thus, any method that can be used to slow, prevent, or non-surgically release post-surgical adhesions that compromise the bowel is of significant value to physicians and their patients.

Adhesions have also been identified as a leading cause of secondary female infertility [9]. The Clear Passage Physical Therapy group has previously reported the successful use of this manual soft tissue physical therapy in the treatment of fallopian tube occlusion and treatment of dyspareunia and dysmenorrhea secondary to adhesions [10,11]. Following publication of those studies, the same manual soft tissue physical therapy was applied to patients with documented abdominal adhesions following recurrent abdominal surgeries, and to patients presenting with current or recurring partial and total SBOs as a non-surgical treatment option.

2. Experimental Section

The two patients presented in this retrospective study were required to complete a standard Patient Intake Questionnaire detailing their pain, medical, and surgical history. Body Mass Index was calculated for each patient using the online BMI calculator from the NIH National Heart, Lung, and Blood Institute. [12]

Those patients who indicated a history of small bowel obstruction (SBO) on the patient intake form were asked if they were willing to allow us to use their data in a small, investigative, retrospective study. Each patient then signed an Informed Consent document. Frequency, timing, and severity of SBO episodes and all abdominal or pelvic surgeries were noted in their charts. Each patient was required to submit all relevant medical records and operative reports from which the medical history presented in this case study is summarized. Both patients presented in this case report had sought medical treatment and diagnostics for adhesions and bowel obstructions from multiple physicians and radiologists prior to manual physical therapy treatment.

Previous medical histories for each patient were obtained in accordance with HIPAA regulations. Detailed clinical records were kept of each patient throughout the course of therapy, including symptomatic complaints, areas treated, techniques used, and treatment date/duration in accordance with the American Physical Therapy Association guidelines.

Upon initial evaluation and discharge assessment, patients were asked to rate their pain on a scale from 0 to 10, with 0 being no pain and 10 being debilitating pain. The patients were also asked about quality of life measures, including the impact of pain on daily activities and dietary restrictions due to their condition.

Findings from the initial evaluation, which included patient history, previous pathology reports, and physician diagnoses, and visual, palpatory, postural, and movement exams, were correlated to determine dysfunctional areas needing treatment. In these cases, restrictions, scars, or adhesions were palpated by the therapists, major organs were identified, and decreased mobility of specific organs was determined. The evaluation included layer palpation of the myofascial and visceral structures, starting with the most superficial structures and progressing to the deepest. The development of tactile skills includes the ability to detect tissue and visceral texture abnormalities and restricted mobility [13]. The therapists assessed tissue temperature, moisture, shear, extensibility, and texture throughout the abdominopelvic viscera, with a special focus on areas deep to surgical scars. Testing visceral mobility consisted of the therapist palpating the tissues, then making precise manual movements to assess the ability of the organs to move directly over surrounding organs and tissues.

The patients were treated via a site-specific intensive manual physical therapy that occurred for 4 h a day for 5 consecutive days. In the case of these two patients, approximately 70% of the therapists’ time was utilized directly on the adhered areas of the abdomen and pelvis. The manual physical therapy protocols utilized by the therapists have been previously described in other studies where the primary focus of therapy was the manual decrease of adhesions, and the outcomes were a return of normal mobility and motility to previously adhered organs. [10,11,14] Thus, the therapy described in these studies and on those patients may be applied to adhered areas of any of the abdominal or pelvic organs, including the reproductive, digestive, urinary, and other organs within and external to the peritoneum.

Briefly, the protocol consists of over 200 individual manual techniques focused on creating what we theorize are micro-failures of the adhesive crosslinks, the building blocks of adhesions, by application of various site-specific pressures across adhered areas of the abdominal viscera. Because no means of visual confirmation exists (excluding surgery, which was not performed), macro-failure or deformation of adhesions could only be assumed as visceral mobility improved, and as patients reported increased function and decreased pain. In earlier published studies, the manual physical therapy techniques used for treating abdominal adhesions in patients with histories of adhesion-related SBO were used to clear adhesion-related blocked fallopian tubes. Independent blinded radiologic tests documented that the patient’s fallopian tubes were no longer blocked by adhesions post-treatment.

The amount and duration of force that is applied to cause these microfailures can be significant, but vary within the tolerance of each patient and according to the site of the body that is being treated. For example, the same technique applied to the abdomen will use much greater force than when applied to the ovary or fallopian tubes. The manual physical therapy approach is one of whole body treatment, treating not only the abdomen in these patients, but also other areas of the body in which decreased function or mobility was identified during the evaluation. In general, patients received about 14 h of this manual therapy directly to perceived adhered abdominal structures for every 20 h of therapy; the remaining six hours were spent with history review, evaluation, treating other symptomatic areas including nearby myofascial structures (low back, lower extremities, shoulders, and neck, etc.), and paperwork. Via palpation and an understanding of the anatomy, therapists focused on treating the adhesions, rather than treating the underlying viscera. Except at their ligamentous attachments and their normal anatomical attachment to other organs, abdominal and pelvic organs should be able to glide freely over each other. When therapists were unable to palpate gliding organs freely, the restrictions were noted as decreased mobility. This frequently occurred at the sites of prior surgeries.

While the force used by the therapists was sometimes significant, it is interesting to note that, except for some temporary soreness, there have never been any significant adverse events in the hundreds of patients treated with abdominal or pelvic adhesions using this therapy. This observation seems to refute the commonly held belief among some manual therapists that abdominal structures should only be treated lightly and infrequently. Notwithstanding, a BMI of above 36 and surgery within 12 weeks preceding therapy are considered contraindications by the clinic for this treatment. Both patients presented in this case report had low BMIs, allowing for easy palpation of the internal organs and adhesions, scars, and restrictions. In clinical trials and published studies, these techniques increased mobility and decreased pain in patients with significant surgical histories, indicating adhesion formation [10,14,15,16].

Patients are typically followed for at least a year following treatment via a voluntary survey.

3. Case Reports

3.1. Patient 1

Patient 1 was a 69-year-old Caucasian male with a BMI of 17.7 and a history of GERD, asthma, hypertension, emphysema, recurrent SBO, and bilateral inguinal hernias. His surgical history included SBO surgery at birth, childhood appendectomy, 3 laparoscopically repaired hernias from 2008–2010 with a surgical mesh inserted, Nissen fundoplication and partial thyroidectomy in 2010, laparotomy for SBO secondary to extensive adhesions in July 2010 and January 2011. Immediately after surgery in 2011, Patient 1 underwent a small bowel radiographic series that showed an incomplete SBO at the junction of the proximal mid-ileum, and dilation throughout the small bowel, likely due to adhesions per the radiologist (Figure 1A). He was still experiencing symptoms of SBO (bloating, nausea, inability to eat normally) three months following the 2011 laparotomy, and reported a significant impact on his quality of life, focused on the changes to his diet that occurred after the SBO. He also reported abdominal tightness and significant intermittent pain (10/10 on a pain scale).

Figure 1. Small bowel radiographs of Patient 1 documenting SBO resolution over time. Arrows note areas of obstruction. (A) Before therapy in 2011: incomplete SBO due to adhesions visualized by X-ray, showing dilation of the proximal mid-ileum. (B) Twelve months after therapy in 2012: mild stricture at the terminal ileum with no other small bowel abnormalities. (C) After 40 h of therapy: normal small bowel series X-ray in 2012.

Patient 1 received no further medical interventions after his 2011 radiography prior to receiving this manual physical therapy treatment. Upon initial physical therapy evaluation, he presented with pain; visible scarring superficial to tissues that felt like deep palpable adhesions (consistent with his physician’s 2011 diagnosis of abdominal scarring), decreased visceral mobility (decreased ability for organs to glide normally), and tightness throughout the abdomen; myofascial, osseous and visceral hypomobility; and decreased quality of life due to SBO. He also presented with decreased strength and range of motion in both hips and trunk, and in his cervical, thoracic, and lumbar spines at the initiation of his physical therapy regimen.

In 2011, Patient 1 underwent 20 h of intensive manual physical therapy over the course of five days with a focus on improving range of motion and decreasing scar tissue, adhesions, and soft tissue restrictions. Primary goals of therapy included decreased SBO symptoms and a decrease in future bowel obstructions. At discharge from physical therapy, Patient 1 presented with improved range of motion in the trunk, cervical, thoracic, and lumbar spine, and hips by at least 5 degrees for each range of motion measurement (data not shown). Abdominal mobility and tightness had also improved. Upon return to his home state, he underwent follow-up diagnostic evaluations by a blinded, independent radiologist. Findings showed an ileum stricture but no other obstructions in the bowels (Figure 1B). Furthermore, this patient reported no further obstructions or SBO symptoms over the 12 months following therapy.

In 2012, following a diagnostic test showing a decreased diameter of the ileum (Figure 1B), Patient 1 was treated again for 20 h over the course of 5 days. Once again, he demonstrated improvement in all areas tested after twenty additional hours of manual physical therapy, including a minimum of 5 degrees increase in all ranges of motion that were measured to be decreased at the re-evaluation (data not shown). Ten days after the conclusion of therapy, the patient underwent a small bowel series, again conducted by a blinded independent radiologist. Results showed a normal bowel, with no kinking, constricting lesions, or abnormal masses noted (Figure 1C). Patient 1 reported no further SBO symptoms for one year following the second course of treatment, for a total time of two years with no further medical interventions for SBO or SBO symptoms.

3.2. Patient 2

Patient 2 was a 49-year-old Caucasian female with a BMI of 21.8 and a significant history of recurrent abdominal adhesions as a result of multiple surgeries and injuries, including benign lumpectomy of the breast, dilation and curettage, motor vehicle accident with injury to the soft tissue of the chest wall resulting in migraine headaches and fibromyalgia, and injuries to bilateral wrists. She also had a past medical history of systemic lupus, chronic fatigue, fractured right upper extremity and several fingers, left knee surgery, mild arthritis, brown recluse spider bites, and multiple miscarriages.

Patient 2 underwent the first of a series of surgeries beginning with a breast lumpectomy. Within weeks of this surgery, she was hospitalized as she was unable to keep any food or fluids down and all bowel movements ceased, accompanied by severe bloating and abdominal pain. After six days in the hospital, an emergency exploratory laparotomy revealed adhesion-related bowel obstructions. She had cysts removed from her ovaries and colon, as well as an appendectomy in June 2006. Two weeks later (July 2006), she underwent her second abdominopelvic surgery, the first to treat adhesion-related small bowel obstruction, in which the surgeon resected a fibrous band from her transverse colon to her posterior peritoneum, which had caused an internal herniation. In August 2006, the patient underwent a third abdominopelvic surgery, an exploratory laparotomy for a spigelian hernia, ovarian mass resection, oophorectomy, and adhesiolysis.

Despite undergoing two adhesiolysis procedures, the patient continued to experience symptoms of bowel obstruction, including abdominal distention, nausea, vomiting, pain, and constipation immediately following the surgeries.

In January 2007, she was again diagnosed with abdominal adhesions, a diagnosis confirmed during a laparotomy performed in July 2007, which was her fourth abdominopelvic surgery. That surgeon noted and lysed dense intra-abdominal adhesions and scar tissue that were binding the loops of the small intestine; the physician also performed an umbilical hernia repair with mesh. In October 2007, she underwent a fifth abdominopelvic surgery: bilateral inguinal hernia repair.

In July of 2008, she underwent a sixth abdominopelvic surgery, another exploratory laparotomy, in which the surgeons noted extensive abdominal adhesions, a nearly complete SBO due to adhesions causing eight to ten acute angle kinks of the bowel, and adhesions around the stomach causing it to become elongated, J-shaped, and adhered to the anterior abdominal wall. Shortly thereafter, she underwent a complete hysterectomy and oophorectomy due to uterine fibroids and ovarian disease, her seventh abdominopelvic surgery. Thus, she underwent seven abdominopelvic surgeries, most related to adhesions and/or SBO, within a period of 30 months. In November 2008, the patient was diagnosed with recurrent idiopathic abdominal adhesions and informed of the need for an eighth abdominopelvic surgery, a laparotomy for adhesiolysis to treat the recurring SBO symptoms. Feeling that she needed to take another path, she elected to try manual physical therapy in November 2008 rather than undergo further surgical intervention for her current partial SBO.

During the physical therapy initial evaluation, Patient 2 reported constant dull aching abdominopelvic pain averaging 7/10 on the pain scale; intermittent dull aching pain in her torso at 10/10 on the pain scale; and pain in one lower leg that was intermittent dull aching, averaging 5/10 on the pain scale in an area that was bitten by a brown recluse spider. She reported pain with bowel movements, urination, and intercourse. She had lost 18 pounds and was on a totally liquid diet at the time of the initial evaluation. She reported pain and a severe decrease in quality of life, beginning with her first surgery (June 2006), which forced her to leave the workforce. She presented with severe abdominal pain and decreased range of motion at the cervical, thoracic, lumbar, and sacral regions. Physical therapy palpation and tests revealed severe visible and palpable scars and adhesions, severe restrictions in visceral abdominal mobility, decreased myofascial and osseous mobility and range of motion, and significant postural asymmetries. Current medication at the initiation of treatment was Darvocet-N 100 every 6 h for pain.

Like Patient 1, Patient 2 underwent 20 h of intensive manual physical therapy over the course of 5 days with the goals of improving range of motion, flexibility, strength, and posture, as well as decreasing adhesions in the bowel and abdominal wall in an attempt to decrease or negate the need for her pending surgery and to prevent a total small bowel obstruction. Again, the therapists used similar techniques as noted in their earlier published studies in which they focused on adhesions affecting endometrial and tubal structures. That is, they treated the adhesions that existed on and within the interstitial spaces, as well as on and within abdominal and pelvic organs, as the primary focus of their therapy.

At discharge from physical therapy, Patient 2 reported that pain had decreased by 90% or more, and she was able to return to a normal diet. The therapist noted improvement in range of motion to within functional limits and improved posture, increased visceral mobility, increased myofascial and osseous mobility, and significantly decreased pain with urination, sexual intercourse, and bowel movements. Several weeks following discharge from therapy, Patient 2 reported that she had regained the 18 pounds she had lost due to her compromised bowel, and she had returned to a normal quality of life. She was able to cancel the scheduled surgery for adhesiolysis and SBO. At her one-year follow-up from therapy, Patient 2 reported experiencing no additional SBOs or SBO symptoms, and that no further surgical interventions were needed or performed.

4. Conclusions

In cases where non-surgical management is unsuccessful, the current standard medical treatment for SBO caused by adhesions is surgery. Unfortunately, surgery is implicated as the most common cause of abdominal adhesions and adhesion-related SBO [5]. Previous studies have shown that the decrease in pain associated with abdominal adhesions after surgical adhesiolysis lasted up to one year; the subsequent return of the pain has been hypothesized as due to new or expanded adhesion formation [17,18,19]. In the US in 2010, 70,194 patients underwent small bowel resection surgery with an average hospitalization of 14.2 days, an average cost of $114,175, and a patient death rate of 6.75%; 89,222 patients underwent surgery for adhesiolysis, an average hospitalization of 8.4 days, an average cost of $65,955, and a patient death rate of 2.3% [20]. Those numbers are staggering when it is considered that, based on prior studies, 35% of those patients who undergo pelvic or abdominal surgery will likely be readmitted for surgical intervention for adhesiolysis over the next 10 years [6].

Here, we reported the use of manual physical therapy for the treatment of SBO symptoms in two patients who presented with numerous, frequently recurring bowel obstructions. Furthermore, both patients had entered a cycle of surgery to remove adhesions, followed by the formation of post-surgical adhesions, followed by another adhesiolysis surgery, and so on. In each case, post-surgical adhesion formation occurred more rapidly and more severely with each successive surgery. Patient 2 experienced only 12 weeks between the most recent surgery for SBO and her next partial SBO, when she received her physician’s recommendation for another (eighth) abdominal surgery. Her surgeon had scheduled the next surgery for adhesiolysis when she opted to try this manual physical therapy treatment instead.

Both patients reported lasting pain relief and avoidance of further SBOs after therapy that exceeded their prior post-surgical experiences. We hypothesize that the positive responses from the therapy were due to the reduction of adhesions and the avoidance of new post-surgical adhesions that were causing SBOs and pain in both patients. The use of this non-surgical procedure appears to be of direct patient benefit, and the cost is significantly lower than surgery (SBO surgery costs $114,175; adhesiolysis surgery costs $65,955; this therapy costs $5,200). Unlike abdominal surgery, the therapy has no associated risks from general anesthesia. Data to date (from approximately 50 patients seeking therapy for SBO) shows that it appears to have little or no risk of major adhesion formation, infection, or peritonitis. No hospital stay is required with the therapy, because there is virtually no recovery period.

The use of manual physical therapy is not a new concept in the treatment of patients for a wide variety of medical conditions, including the management of adhesions [21,22,23,24,25,26]. Orthopedic physicians refer to manual physical therapy for the treatment of adhesive capsulitis [27]. Oncologists call for manual therapy to treat post-mastectomy scars [28]. Thus, this new utilization of this manual physical therapy regimen has some precedent in clinical care.

A recently published study suggested that massage therapy reduces inflammation after muscle damage by decreasing the levels of inflammatory cytokines produced [29]. This correlates with our observations that symptoms hypothesized to be attributed to the presence of adhesions do not recur after attempted lysis via manual physical therapy. Another study in animals investigated whether a manual massage technique of a surgical area was capable of preventing the formation of adhesions. That study demonstrated fewer adhesions in treated animals as compared to untreated controls [30]. In another study, the manual technique used in these two cases was documented in blinded radiographic reports to open fallopian tubes that were occluded by pelvic adhesions. The long history of clinical physician referrals from other branches of medicine for manual therapy to treat adhesive conditions, along with the studies noted above, supports the observation that manual lysis of adhesions may be a viable alternative to SBO surgical treatment.

Without visual confirmation, we can only hypothesize that the manual soft tissue physical therapy protocol effectively lyses the adhesions by causing microfailure of the attachments of the individual crosslinks, allowing return of normal anatomical organization, and formation of more normal tissue structures [31,32,33,34]. If true, these micro-failures of crosslinks and macro-failures of adhesions appear to have similar immediate end results for the patient as surgical adhesiolysis. However, manual manipulation of the soft tissue does not appear to activate the level of inflammation observed with surgical healing. Thus, the adhesions appear to be lysed without the significant induction of new adhesion formation that often follows abdominal and pelvic surgery.

This hypothesis from our human-based case report is supported by historical data in rat models for post-surgical healing in which manual physical therapy was performed on the soft tissues of the surgical incision site, with animals treated exhibiting increased healing as compared to no treatment [35,36]. This therapy also avoids the risks of anesthesia, the high cost, and the moderate death rate of surgery. It also appears to minimize the risk of surgical infection and hospitalization following surgery. Because manual physical therapy has virtually no recovery time, patients are able to recover and participate in daily activities immediately. In follow-up assessments, this return of mobility appears to further deter the reformation of adhesions and enhance the return of more normal tissue organization. This is the same idea that surgeons promote when surgical patients are encouraged to walk and exercise shortly after surgery. Early mobility promotes increased blood flow and an earlier return of the normal range of motion. We note that patients who underwent the manual therapy demonstrated increased range of motion in both cases; an early return to normal activities of daily living simply enhanced the benefits.

A formal, well-structured clinical trial is currently underway for the investigation of a nonsurgical approach for the treatment and prevention of SBOs to provide statistical significance to the observations from our human efficacy data presented in this case report.

Conflict of Interest

Belinda F. Wurn, PT, and Lawrence J. Wurn, LMT, are the sole shareholders of Clear Passage Therapies, Inc. Wurn Technique is a Therapeutic Method for Treating Infertility in Humans and Animals, patent pending with the United States Patent and Trademark Office, Application No. 09/887,884 filed June 22, 2001 by Lawrence J. Wurn and Belinda F. Wurn. All other authors declare no conflicts of interest.

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MDPI and ACS Style

Rice, A.D.; King, R.; Reed, E.D.; Patterson, K.; Wurn, B.F.; Wurn, L.J. Manual Physical Therapy for Non-Surgical Treatment of Adhesion-Related Small Bowel Obstructions: Two Case Reports. J. Clin. Med. 2013, 2, 1-12. https://doi.org/10.3390/jcm2010001

AMA Style

Rice AD, King R, Reed ED, Patterson K, Wurn BF, Wurn LJ. Manual Physical Therapy for Non-Surgical Treatment of Adhesion-Related Small Bowel Obstructions: Two Case Reports. Journal of Clinical Medicine. 2013; 2(1):1-12. https://doi.org/10.3390/jcm2010001Chicago/Turabian Style

Rice, Amanda D., Richard King, Evette D’Avy Reed, Kimberley Patterson, Belinda F. Wurn, and Lawrence J. Wurn. 2013. “Manual Physical Therapy for Non-Surgical Treatment of Adhesion-Related Small Bowel Obstructions: Two Case Reports” Journal of Clinical Medicine 2, no. 1: 1-12. https://doi.org/10.3390/jcm2010001APA Style

Rice, A. D., King, R., Reed, E. D., Patterson, K., Wurn, B. F., & Wurn, L. J. (2013). Manual Physical Therapy for Non-Surgical Treatment of Adhesion-Related Small Bowel Obstructions: Two Case Reports. Journal of Clinical Medicine, 2(1), 1-12. https://doi.org/10.3390/jcm2010001

Amanda D Rice ¹, Leslie B Wakefield ¹, Kimberley Patterson ¹, Evette D’Avy Reed ¹, Belinda F Wurn ¹, C Richard King III ¹, Lawrence J Wurn ¹

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PMCID: PMC3977160  PMID: 24711912

Abstract

In this case study, we report the use of manual physical therapy in a pediatric patient experiencing complications from a life-threatening motor vehicle accident that necessitated 19 surgeries over the course of 12 months. Post-surgical adhesions decreased the patient’s quality of life. He developed multiple medical conditions, including recurrent partial bowel obstructions and an ascending testicle. In an effort to avoid further surgery for bowel obstruction and the ascending testicle, the patient was effectively treated with a manual physical therapy regimen focused on decreasing adhesions. The therapy allowed return to an improved quality of life, significant decrease in subjective reports of pain and dysfunction, and apparent decreases in adhesive processes without further surgery, which are important goals for all patients, but especially for pediatric patients.

Key words: physical therapy techniques, tissue adhesions, pediatrics, musculoskeletal manipulations

Introduction

In 2010, motor vehicle accidents (MVA) accounted for 3421 injuries and 1428 fatalities of children under the age of 15. Pedestrian-involved MVAs for children under the age of 15 have a high fatality rate (85%), with only 52 of 345 children surviving the accidents. Of the 52 children that survived, 33 (63%) were severely injured.1 Thus, 326 of 345 (94%) died or were severely injured. Those children who survive severe injuries often undergo weeks of hospitalization followed by lengthy recovery and rehabilitation periods after the initial MVA. After recovery from the initial trauma, patients with extensive surgical and/or trauma histories are at high risk for further complications and hospitalizations due to the formation of adhesions.2

Adhesions are fibrous bands of connective tissue that bind the skin and/or internal structures (organs, muscles, bones, connective tissues) into abnormal formations that frequently impact their normal function. The formation of adhesions is not an aberrant occurrence, but can be considered an overzealous healing process of the body in which a structural matrix is created in an anatomically incorrect location. With each successive surgery, there is an increased risk of developing adhesions with the potential for developing life-threatening conditions such as bowel obstructions, reduction in respiratory capacity,3,4 and cardiac function,5 as well as causing pain. Physical trauma also has the ability to generate adhesions, particularly in instances of life-threatening trauma.6 Adhesions have been identified as contributing to a wide variety of conditions, including pain, infertility, bowel obstruction, and decreased range of motion, thereby significantly impacting the patients’ quality of life.7-9

Adhesion formation is of particular concern in pediatric patients because of its ability to negatively impact children’s quality of life. These internal scars can impact the child’s diet, ability to participate in sports, or normal play. Abdomino-pelvic adhesions may contribute to the requirement for daily medication for pain or bowel maintenance for the remainder of the patient’s life in order to function at a level close to that of non-traumatized children.10 There is also a strong potential for pain and additional medical complications as the pediatric patient enters periods of rapid growth. Here we present a case involving the use of a site-specific manual physical therapy to treat a young child who was involved in a MVA as a pedestrian, sustained severe injuries, and developed severe scarring and adhesion formation that affected his quality of life significantly because of healing from those injuries.

Case Report

The patient was an 11-year-old boy who had been involved in a MVA versus pedestrian accident in which a large vehicle rolled over his pelvis, resulting in an open-book pelvic fracture, splitting the osseous structure of his pelvis. He sustained life-threatening injuries for which he underwent 19 surgeries over the course of one year in order to repair damage that resulted from the accident (Table 1). Because of healing from both the number of surgeries and trauma from the accident, the patient developed extensive scarring and abdominal adhesions as well as post-traumatic stress disorder (PTSD). He had traditional physical therapy for three months to facilitate his ability to walk and perform daily functions. However, the patient experienced recurrent partial small bowel obstructions (SBO) that were treated non-surgically, and he required a laxative, polyethylene glycol (PEG) 3350 oral, for maintenance of bowel function. The use of laxatives caused the patient distress and reportedly impacted his life significantly, causing rectal fecal leakage and thus furthering emotional distress in a pediatric patient medicated for PTSD.

Table 1.

Medical treatment timeline beginning at the initial trauma caused by the collision of a motor vehicle with the patient as a pedestrian.

D, day post trauma; L, left.

^*Surgical interventions.

Upon initial physical therapy evaluation at a specialized manual therapy clinic, 19 months following the accident, the patient reported frequent constipation, pain of up to 7/10 during bowel movements, weakness and tingling in his left lower extremity, and general pain that increased throughout the day. He expressed numerous goals, including the ability to participate in more athletic activities, to run a marathon, and to eliminate the requirement for pharmaceutical maintenance of bowel function. Findings from the initial evaluation, which included visual, palpatory, postural, and movement exams, were correlated with patient medical history, previous surgical reports, and physician diagnosis to determine adhered and dysfunctional areas requiring treatment. Restrictions, scars, or adhesions were palpated by the therapists, major organs were identified, and decreased mobility of specific organs was determined. The patient was ambulatory but exhibited a shuffling gait and a wide base of support with both hips held in external rotation. He presented with decreased range of motion in several areas that impacted his activities of daily living (Table 2), decreased strength, postural deviations, and biomechanical dysfunction, as well as myofascial, visceral, and osseous restrictions due to scarring and adhesion formation after the original trauma, and from the 19 required surgical interventions. The extensive adhesions in his pelvis had also caused his left testicle to ascend into the inguinal canal, where it was unable to be palpated, but was visible by diagnostic ultrasound.

Table 2.

Range of motion measurements demonstrating improvements in tests identified as not within normal limits at the initial evaluation.

^*Single measure only.

The patient was treated with an intensive site-specific manual physical therapy called the Clear Passage Approach (CPA) or Wurn Technique for 4 hours a day for 5 consecutive days (a total of 20 hours). In accordance with the American Physical Therapy Association guidelines, detailed clinical treatment records were maintained on the patient throughout the course of therapy. These included symptomatic complaints, areas treated, duration, and techniques performed. Unlike traditional physical therapy, which often consists of exercise and modalities, the CPA utilizes a variety of techniques focused on creating microfailures of the adhesions by a variety of site-specific sustained pressures across restricted fascial bands of adhered tissues and organs.11 The amount and time of force that was applied to cause these microfailures were often significant, but varied with the tolerance of the patient and according to the location and delicacy of the tissues that were being treated. In previously published clinical trials and studies, these techniques increased the range of motion, reversed infertility, prevented SBO, and decreased pain in patients with histories indicating significant adhesion formation.12-15

Therapy focused on decreasing adhesions in order to decrease pain and to increase function and range of motion. The patient’s response to treatment was significant and readily apparent to him, the therapists, and his physicians. Following the initial 20 hours of treatment, the patient demonstrated an apparent decrease in adhesions, evidenced by increased range of motion (Table 2) of at least 5 degrees for abnormal tests, and by improved myofascial, visceral, and ligamentous mobility accessed via palpation. He reported decreased abdominal pain, increased frequency of normal bowel movements, and decreased use of laxatives by 50%.

Upon urologic re-evaluation, his physician reported that the scar adhesions in his scrotum had decreased significantly. The urologist was optimistic that additional treatment would continue to decrease the scarring in his left inguinal region in order to aid in the increased mobility of the testis, possibly negating the need for surgical intervention for the ascending testicle. He recommended an additional 20-hour regime of manual physical therapy.

Seven months after the first CPA therapy (26 months following the trauma), the patient returned for an additional 20 hours of treatment focused on further decreasing adhesions. Following that therapeutic series, the patient again showed an apparent decrease in adhesions, evidenced by improvement in range of motion (Table 2); improved myofascial, visceral, and ligamentous mobility; decreased pelvic and abdominal pain; decreased left lower extremity pain and edema; and improved gait. Pain and functional levels improved to the point that he reported no pain with bowel movements, increased frequency of bowel movements, and a further decrease in the laxatives previously required for proper elimination. Upon further urologic examination, the physician noted that the patient demonstrated additional decreases in the scarring and adhesions in the inguinal area (Figure 1A, B), and the previously ascending left testicle was able to be reduced manually into the upper scrotum (Figure 1C, D). Ten months following the second treatment, his parents reported no surgical intervention for the ascending testicle and no further partial SBOs. Moreover, he was able to return to a normal diet, improving not only his health but also his return to normal daily activities after the accident. They reported that improvements in the patient’s physical ability to participate in normal activities also improved his mental status; he no longer required medication for PTSD associated with the MVA.

Figure 1.

Ultrasound comparison of the scrotum demonstrates improvement in scar formation between the first and second rounds of treatment. A-B: transverse images of the scrotum. (A) Ultrasound before the second round of treatment showed a thickened scrotal wall with complex echogenicity. (B) Ultrasound after the second round of treatment showed improvement in the scrotal wall and echogenicity. C-D: Transverse ultrasound images of the left testicle. (C) Image from before the second round of treatment showing the testicle located in the inguinal canal, surrounded by scar tissue with complex echogenicity. (D) Image from after the second round of treatment showing the testicle located farther down in the inguinal canal with less scar tissue, demonstrating complex echogenicity surrounding the testicle. E-F: Longitudinal ultrasound images of the left testicle. The surrounding tissue of the testicle after treatment (E) is decreased in complexity as compared to before the second round of treatment (F).

Discussion

This case report presented the use of a site-specific manual physical therapy focused on the decrease of adhesions to promote the healing and return to normal daily activities in a child who received severe traumatic injuries and post-surgical adhesions as a result of a major pedestrian versus vehicle accident. Prior to therapy, the patient had undergone 19 surgeries in the course of 12 months secondary to the accident and had developed severe adhesions at the sites of the trauma and the surgical scars. The degree of adhesion formation was likely compounded by the requirement of the negative pressure wound dressing (VAC),16 due to the extensive internal injuries and daily surgical intervention. Use of the VAC has been linked to increased levels of adhesions when used for more than 7 days,17 this patient had VAC for 12 days; therefore, the level of scarring and number of adhesions were not unexpected.

The patient had utilized traditional physical therapy to strengthen and retrain his body to walk and improve his ability to perform daily activities prior to undergoing CPA treatment. We believe the manual therapy complemented his earlier therapy by decreasing the post-traumatic and post-surgical adhesions, aiding this patient’s ability to walk with an improved gait, and to participate in activities that were important to him but that he could not achieve prior to CPA therapy. Thus, the therapy significantly improved his quality of life and opened opportunities for a more normal and functional childhood and future life. He recently participated in a multiple-day long-distance bike ride and a camping trip, which was not possible prior to CPA treatment.

This is the first report in the literature of the use of manual physical therapy in a pediatric patient involved in a pedestrian MVA trauma to treat the adhesion-related complications from the trauma and subsequent surgeries. This is also the first report of non-surgical physical therapy treatment of a testicle that had ascended out of the scrotum and into the inguinal canal due to scarring and adhesions.

Because the patient was a young child when he was injured, it is expected he will require continued treatment throughout puberty and into early adulthood, particularly during periods of rapid growth. During these times of growth, some scars and adhesions that were not previously symptomatic could become so, causing pain or dysfunction as his body grows and stretches around the adhered areas. The need for interventions to treat adhesions throughout periods of growth in patients injured as children is common, often observed in pediatric skin graft patients.18 The intervention of this manual physical therapy is less traumatic, does not carry the risks of additional surgery, and provides a positive outcome for the patient. The use of CPA in treating pediatric patients with extensive surgical or trauma-induced scarring is currently under investigation.

Conclusions

Given the outcome of this case report, it is evident that the use of manual physical therapy to treat post-surgical complications in pediatric patients to avoid additional surgery is an advisable treatment alternative.

Funding Statement

Funding: none.

References

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Amanda D Rice ¹, Leslie B Wakefield ¹, Kimberley Patterson ¹, Evette D’Avy Reed ¹, Belinda F Wurn ¹, Bernhard Klingenberg ², C Richard King III, Lawrence J Wurn ^1,*

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PMCID: PMC4934500  PMID: 27429266

Abstract

A validated questionnaire to assess the impact of small bowel obstructions (SBO) on patients’ quality of life was developed and validated. The questionnaire included measurements for the impact on the patients’ quality of life with respect to diet, pain, gastrointestinal symptoms, and daily life. The questionnaire was validated using 149 normal subjects. Chronbach’s alpha was 0.86. Test-retest reliability was evaluated with 72 normal subjects; the correlation coefficient was 0.93. Discriminate validity was determined to be significant using the normal subject questionnaires and 10 questionnaires from subjects with recurrent SBO. Normative and the level of impact for each measured domain were established using one standard deviation from the mean in the normal population and clinical relevance. This questionnaire is a valid and reliable instrument to measure the impact of SBO on a patient’s quality of life related to recurrent SBOs; therefore, establishing a mechanism to monitor and quantify changes in quality of life over time.

Keywords: small bowel obstruction, quality of life questionnaire, validated survey, small bowel obstruction questionnaire

1. Introduction

Small bowel obstruction (SBO) is a common medical occurrence, most commonly a complication of surgery secondary to the formation of post-surgical adhesions [1,2]. It has been reported previously that 50%–93% of patients who undergo abdominopelvic surgery will develop adhesions [3,4,5,6] and 35% will be hospitalized for a bowel obstruction within 10 years of the first surgery [1,2,5,6,7,8,9]. The diagnosis of SBO is based upon symptomatic complaints and radiological tests, with resolution of the SBO determined by improvement in radiological tests and/or resolution of patient-reported symptoms in cases of nonsurgically treated obstructions [9,10]. A wide variety of symptoms accompany a bowel obstruction, impacting multiple aspects of life. Patients with recurrent obstructions often have a limited or liquid diet requirement, experience pain in multiple areas of their bodies, and have gastrointestinal symptoms that impact their quality of life, including bloating, nausea, vomiting, diarrhea or constipation, and the inability to plan or engage in normal social activities.

Currently, there is no validated tool to assess patient reported quality of life specific to patients experiencing SBOs. SBOs and the experiences of the patients with recurrent SBOs are not directly comparable to other gastrointestinal problems for which validated questionnaires are available. The questionnaire for patients with functional gastrointestinal disorders does not address pain or diet [11,12]; the QOL questionnaire for patients with a colostomy or ileostomy is not generally applicable to the SBO population [13,14]; the bowel function index is not complete and focused on opioid induced constipation [15]; and the health related quality of life (HRQOL) measurement questionnaires are general and do not address the specific symptoms experienced by SBO patients [13,14,16,17]. Furthermore, clinicians rely upon subjective, qualitative measures reported by patients presenting with symptoms of SBO. A quantitative noninvasive tool capable of being used in both acute presentation of SBO and also in routine care settings to track the symptoms and impact on QOL could allow for earlier interventions and can aid in measurement of treatment regimen efficacy for patients.

Therefore, we developed a questionnaire to provide an instrument to measure various aspects of life impacted by SBO specific to this patient population. This instrument was designed to assess the degree to which a patient’s quality of life is affected by the symptoms of recurrent SBOs, including the overall domains of diet, gastrointestinal (GI) symptoms, pain, quality of life (QOL), and medication requirements.

2. Experimental

2.1. Instrument Development

The questionnaire was developed by an independent physical therapy group that included treating therapists, the clinic’s medical director, biostatisticians, and collaborative scientists to address areas of life impacted by small bowel obstructions. Development was based on standard clinical observations and patient responses over the course of 4 years from intensive interviews with patients whose lives were disrupted by bowel obstructions. We noted histories, symptoms, pain, diet, concerns for the future, and other conditions that patients reported as negatively affecting their quality of life. This instrument was designed to measure improvement of self-reported symptoms related to SBOs after physical therapy treatment for abdominal adhesions. A total of 48 English-speaking patients provided feedback during the development of the instrument, 34 female and 14 male, with an average age of 53.9 ± 16 years. Each of the patients had experienced recurrent SBOs, ranging from two episodes over their lifetime to monthly episodes of partial SBOs. During the initial interviews with the physical therapists that lasted on average 60 min, patients were queried regarding symptomatic complaints that were current as well as those experienced during a partial SBO episode. The physical therapists noted the symptoms that caused the patients the highest degree of stress and negative impact on their lives. Based upon the symptomatic complaints from these 48 patients and scientific input, the questionnaire was developed to assess the most common symptomatic complaints of this patient population. The questions were designed to be easy to understand and administer, to provide an overall quantitative score for the impact on quality of life due to SBO, and to provide an unbiased report of QOL irrespective of age, level of education, gender, or economic status.

A total of 38 questions were used in the final questionnaire. Questions were divided into domains of diet, GI symptoms, pain, medication requirement, and overall QOL, with additional pain rating sections utilizing the standard pain scale as well as duration of pain. There were five possible responses for the diet, GI symptom, pain, medication, and QOL questions, which were based upon the number of days over the last month that the subject experienced the symptom described in the question. Positive associated experiences were scored from 4 to 0, with 4 being experienced virtually every day (28–30 days over the last month) and 0 being experienced never or almost never (fewer than 3 days over the last month). Negative associated experiences were scored from 0 (experienced virtually every day) to 4 (experienced never or almost never). The score for pain duration was rated from 0 (no pain) to 5 (pain lasting longer than 3 h), and values for the level of pain experienced were rated from 0 to 10 using the standard pain scale. The survey and scoring grid are located in Tables S1–S3.

2.2. Data Collection

Data were collected from two distinct populations: patients with a history of SBO in a focus group, and a population of normal subjects obtained using the online service Survey Monkey (Portland, OR, USA). The questionnaire was formatted for use on Survey Monkey to establish values for each question and domain for a normal population. Subjects with a history of abdominal or pelvic surgery, bowel obstructions, radiation, or chemotherapy were excluded from the study. The SBO questionnaire was included in its entirety with the addition of questions for demographics (gender, education, household income, marital status) and one quality assurance question in which the respondent was instructed to select a specific answer. Subjects were between the ages of 18–65, and no identifying personal information was collected from subjects in the SurveyMonkey arm of the study.

A subset of subjects was re-contacted by Survey Monkey to complete the survey again, 44–46 days after completing the survey the first time, to allow for assessment of test-retest validity for the survey. It was assumed there would be no variation in symptoms over the 6-week time frame. Validation of the questionnaire in subjects with a history of recurrent SBOs was performed using a focus group of 10 patients. These patients were treated for abdominal adhesions in the clinic and had a history of SBO. MaGil Institutional Review Board approved this study.

2.3. Statistics

Descriptive statistics were calculated for all domains for both the normal population and the SBO groups. Two-tailed, unequal variance T-tests were performed for each domain for comparison of the means for the normal population and the SBO patient population. Bonferroni multiplicity-adjusted p-values were determined using standard methods. All statistical analyses were completed using standard protocols in Microsoft Excel.

3. Results and Discussion

3.1. Study Population

The normal population included 258 subject-attempted questionnaires, with 149 included in the final analysis, completed via Survey Monkey. Questionnaires in which the subject responded “yes” to questions regarding previous abdominal surgery (69 questionnaires) or previous SBO (7 questionnaires) were excluded from the analysis. An additional 62 questionnaires were excluded for either an incorrect answer to the quality control question or failure to answer 95% or more of the questions. A total of 234 questionnaires were kept for the final analysis, including both initial and retest questionnaires. A total of 10 SBO focus group patient questionnaires were included in the analysis. The sociodemographics of the subjects are located in Tables 1 and 2. While the SBO population was mainly Caucasian males, the normal population group had a wide variation in all demographics and included 51% female subjects.

Table 1.

Demographics of normal population subjects included in this study.

Table 2.

Demographics for small bowel obstruction (SBO) patients included in this study.

3.2. Validation Study

The primary analysis for reliability of the questionnaire in a normal population included 149 normal subject questionnaires for determining reliability and Cronbach’s α. There were 72 repeat questionnaires, which were compared to the first questionnaire’s values, and retest validity was determined by Pearson product-moment correlation. The normal population general statistics are located in Table 3 for each domain measured.

Table 3.

Normal population basic statistics for the domains in the SBO QOL questionnaire. CI = confidence interval.

3.3. Reliability

The Cronbach’s α coefficient to assess internal consistency for the questionnaire overall in a normal population was 0.86. The split-half coefficient was 0.88 for the normal population. The questionnaire had similar values for Cronbach’s α and split-half for the SBO patient population, with values of 0.86 and 0.94, respectively. This demonstrates a reliable tool over two different populations, where values for Cronbach’s α over 0.7 and a split-half of 0.6 are the minimum acceptable values.

Chronbach α and split-half were calculated for each group after conversion to domain scores. The normal population demonstrated good internal consistency with values of 0.77 for Cronbach’s α and 0.73 for split-half; the SBO patient population also demonstrated acceptable internal consistency with values of 0.81 for Cronbach’s α and 0.99 for split-half analysis.

The test-retest reliability was determined by calculation of Pearson’s correlations for all normal subjects who completed the questionnaire twice using the SurveyMonkey platform. The correlation for the entire questionnaire was 0.93, and 0.93 for the calculated domains for this group of 72 normal subjects, demonstrating good reliability for this instrument and the established domains.

3.4. Validity

Discriminate validity was assessed by comparing the calculated sum-mean values for each of the domains for the normal and SBO patient populations to demonstrate that each population was distinct. Box and whisker plots showing the ranges for responses in each group are located in Figure 1. There were clear differences between the two groups in all domains except pain and medication, which was to be expected, based upon published studies outlining the large percentage of the normal population with chronic pain [18,19,20].

Box and whisker plots for normal and SBO populations for each domain in the SBO survey. Each domain is represented separately: (a) diet; (b) pain; (c) medication; (d) gastrointestinal symptom; (e) quality of life; (f) average pain on the pain scale; (g) maximum level of pain on the pain scale; (h) minimum level of pain on the pain scale; and (i) duration of pain. The box represents the 25% to 75% percentile values; the horizontal line is the median. The whiskers on the box show the main data, while extreme outliers are denoted by open circles, and very extreme outliers are denoted by a starburst. The shading shows the 95% confidence interval around the median.

Table 4 shows multiplicity-adjusted p-values for comparing mean scores between the normal and SBO population, across all domains. All the cumulative quality of life domains (diet, pain, GI symptoms, and QOL) showed a significant difference. Single-question domains (medication, pain duration, and pain scores) were more variable; significant differences were observed in the duration and level of pain reported by the subjects, with the SBO population reporting more severe, sustained pain.

Table 4.

Comparison of the normal population and SBO groups for condition-specific validity for all domains measured in the SBO QOL questionnaire.

3.5. Establishment of Normative Values for Domains

Normative ranges for each domain were determined based upon the 25–50–75 percentiles for each domain score range, while ensuring clinical relevance (See Table 5). The prescribed ranges were supported in the standard deviation for the respective domains in the normal subject population (Table 3). There are four distinct ranges for each domain: no impact, mild impact, moderate impact, and severe impact, shown in Table 6. The normative values for medication usage were assigned based upon clinical relevance, where it was determined to be clinically significant for any subject to require medication more than 10 days a month for this instrument.

Table 5.

Domain quartiles for each measured domain in the SBO QOL questionnaire are based upon one standard deviation in a normal population.

Table 6.

Grouping of the degree of impact on the quality of life for each measured domain. The sum of the domain scores is used to determine the classification in the degree of impact on the patient’s quality of life for that domain. No impact is defined for this questionnaire as the expected values in a normal healthy individual.

The ranges for pain duration and intensity are not cumulative and are represented in this questionnaire as single items to assess the change of pain experienced over time, in line with other validated questionnaires in use for various other conditions. No single range was identified as “normal” or “no impact” due to the variability in these measures that have been reported by others, and the overall design for this questionnaire to be used as a tool to monitor change and/or improvements with treatment. A significant improvement or change in reported pain scores is accepted as a 2-point change per the FDA guidelines and large published studies; a change in the visual analog pain scale of 2 points or greater is considered a significant change [21,22].

Based upon our assigned ranges for all the domains, it was observed that 89.3% of the normal population fell within the defined no impact category for diet, while only 10% of SBO subjects reported no impact in their diet. Within the pain domain, 83.2% of normal subjects reported composite scores within the no impact range, compared to 30% of the SBO subjects. The normal population scores fell within the no impact range for QOL and GI symptoms, 98.6% and 96.6%, respectively; the SBO subjects’ scores for no impact QOL was 30% and 20% for GI symptoms. The definition of a normal population was quite broad for this study, excluding only subjects with a history of bowel obstruction, cancer, chemotherapy, radiation, or surgery. Given these exclusionary criteria, it was expected that 10%–30% of the respondents would have a chronic pain, gastrointestinal disease, or other contributory condition shifting their composite score for a domain outside of the no impact range that would be expected in a normal population [17,18,19,20,23].

4. Conclusions

To the knowledge of the authors, there was no questionnaire specific to patients with SBO to quantify the impact of SBO on their overall quality of life prior to this study. This validated questionnaire allows for unbiased, qualitative assessment of changes in domains of life impacted by SBO symptoms that have been demonstrated to have good reliability and validity via Cronbach’s, split-half, and Pearson analysis. Furthermore, this questionnaire provides a tool for clinical trials and use in general practice that is noninvasive and patient-centered to monitor changes over time in the various domains of life impacted by SBOs.

SBO is a complex condition, impacting not only patients’ gastrointestinal tract and pain levels, but also their ability to perform normal life tasks. A validated QOL questionnaire is needed, given that a large proportion of the population has had or will have a non-malignant bowel obstruction secondary to abdominal or pelvic surgery [2,7,24,25,26]. This non-invasive, quantitative, self-reporting instrument to determine the impact of the SBO symptoms on a patient’s quality of life is useful to help examine disease progression, overall treatment efficacy, and aid in decisions for treatment.

The limitations of this study include a small number of SBO subject responses in the focus group; however, the discriminant validity was significant; therefore, this is believed not to be an issue. Both genders were combined for this analysis and establishment of normative values for each of the domains; however, this is justified as there were no large variations between genders. In addition, the definition of a normal population for the purpose of the SurveyMonkey subject recruitment was not overly stringent in excluding those subjects with chronic pain or functional GI disorders. This was justified in the fact that these subjects are a part of the normal population and did not have a history of previous SBO.

Acknowledgments

No support was received for this study.

Supplementary Files

Supplementary File 1

Click here for the additional data file. ^{(104.9KB, pdf)}

Author Contributions

Study design: All authors. Collection of data: All authors. Data analysis and interpretation: All authors. Manuscript writing: All authors. Final approval of manuscript: All authors.

Conflicts of Interest

The authors declare no conflict of interest.

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Associated Data

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Supplementary Materials

Supplementary File 1

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1 Leonard B Weinstock, 2 Janey S. A. Pratt, 3 Lawrence Wurn, 4 Sharon Hepburn

1 Associate Professor of Clinical Medicine and Surgery, Washington University School of Medicine; Specialists in Gastroenterology, LLC, St. Louis, MO 63141, United States; 2 Clinical Associate Professor of Surgery, Stanford University School of Medicine, Palo Alto, CA 94035, United States; 3 Director of Clinical Research, Clear Passage Therapies, Gainesville, FL; 4 Clinical Director, Clear Passage Therapies, St. Louis, MO

ABSTRACT

A woman with Crohn’s disease with prior resection presented with a one-year history of persistent abdominal pain. The small bowel follow-through radiograph demonstrated the presence of two strictures in the small intestine due to adhesive scarring. Opting for conservative management, the patient underwent a specialized manual physical therapy regimen. Following treatment, the patient experienced a significant decrease in abdominal pain and improved biomechanical function. Radiologic imaging revealed complete resolution of both strictures. Manual physical therapy may be a viable non-operative option to manage small bowel strictures or obstruction.

Keywords: Manual physical therapy, adhesive bowel obstruction and strictures, Crohn’s disease

BACKGROUND

Intraperitoneal adhesions carry significant morbidity, accounting for the majority of mechanical small bowel obstructions (SBO). Current management for SBO includes intravenous fluids, the use of nasogastric suction, and close observation.

This is followed by surgical lysis of adhesions if the obstruction fails to resolve. Repeated surgery in Crohn’s disease can lead to short bowel syndrome. Intraperitoneal adhesions are pathologic strands of fibrous scar tissue that form between the peritoneum, omentum, and bowel loops.

Adhesions are an undesirable corollary of the normal healing response to peritoneal tissue damage incurred by surgery, radiation, infection, or trauma.[1,2] Adhesions can significantly alter spatial anatomy, resulting in obstruction and technically challenging surgeries in the future.[3,4]

Adhesions account for 50 to 80% of mechanical small bowel obstruction (SBO).[5,6] Among SBO secondary to adhesions, it is estimated that 85% are caused by intra-abdominal surgery, 10% follow peritonitis, and 5% are due to an idiopathic or congenital etiology.[7] Mechanical SBO occurs when there is a partial or complete intraluminal blockage of content flow.[8] Luminal blockage leads to proximal dilation of the bowel with decompressive collapse distal to the obstruction. If severe, the bowel may become strangulated with subsequent ischemia, necrosis, and perforation, leading to a significantly elevated risk of mortality.[9,10] Current guidelines outlining the management of SBO are based on the etiology, severity, and location.[11,12,13]

Consensus evidence-based management of SBO remains elusive, with high variability among clinical practices. We describe a patient with two strictures in the small bowel secondary to postoperative adhesions, in which the strictures and adhesions were successfully treated nonsurgically using an innovative, manual physiotherapy regimen.

CASE PRESENTATION

A 37-year-old G3P2 female presented to her gastroenterologist with a one-year history of persistent abdominal pain. She had been diagnosed with Crohn’s disease 19 years earlier, resulting in resection of six inches of her terminal ileum. She reported being entirely symptom-free until one year prior, when she suddenly began experiencing intermittent, dull, and aching pain (4/10) in her right lower quadrant.

Pain occasionally transitioned to sharp, shooting sensations (8/10) with radiation into the right upper quadrant of her abdomen and lumbar area. She endorsed postprandial exacerbation of her symptoms with some high-fiber foods.

On her worst days, the patient reported a functional decline to near 50% in performing activities of daily living. Review of symptoms was positive for dyspareunia and urinary frequency. Past medical history was remarkable for hypertension and Crohn’s disease.

Surgical history was significant for perirectal cyst removal five years prior, C-section with adhesiolysis 10 years prior, appendectomy with bowel resection 19 years prior, and inguinal hernia repair over 30 years before. Abnormal physical exam findings included mild abdominal distention and right lower quadrant tenderness to palpation.

INVESTIGATIONS

Colonoscopy performed shortly after her initial presentation demonstrated normal mucosa and diameter throughout the colon, anastomosis, and neoterminal ileum. One of the authors (LW, Gastroenterology) reviewed the photographs from this exam and agreed with the findings. A small-bowel follow-through revealed two strictures in separate areas of the bowel (Figures 1A and 2A).

DIFFERENTIAL DIAGNOSIS

Differential diagnosis of obstructions in Crohn’s disease includes fibrotic strictures, Leonard B Weinstock et al., IJCR, 2018 2:19 IJCR: http://escipub.com/international-journal-of-case-reports/ 0003, inflammatory tissue in the wall of the intestine, inflammatory mass surrounding the intestine, adenocarcinoma, lymphoma, adhesions surrounding the intestine, and extrinsic adhesions pulling the intestine into a sharp turn.

Treatment

The patient underwent a six-week prednisone challenge to determine if her jejunal narrowing was due to inflammation rather than scar tissue. She experienced no alleviation of symptoms during this period; therefore was subsequently referred for surgical consultation.

A surgeon recommended resection of the stricture. Preferring to pursue non-operative management, she sought out alternative therapy via an Internet search. She came across a manual physiotherapy known as the Clear Passage Approach (CPA), which has previously been shown to decrease abdominopelvic adhesions [34-37].

Five months after the small-bowel follow-through, she initiated treatment with CPA. This method is an intensive, whole-body, manual physical therapy regimen designed to decrease and reverse the bonding of collagenous crosslinks, which are at the core of adhesion formation. The amount of force and time the force was applied to each area was maintained within the tolerance of the subject. In total, the patient participated in twenty hours of CPA over the span of four consecutive days.

The patient was further instructed in self-treatment techniques as well as body and spinal mechanics, core stabilization, posture correction, pelvic floor strengthening, urge suppression, and functional ADL training. All procedures were performed in accordance with the guidelines of the American Physical Therapy Association.

OUTCOME AND FOLLOW-UP

Following treatment, the patient reported a complete decrease in right lower quadrant and lumbar pain and tenderness. She experienced a decreased frequency of nighttime urination. Pain associated with bowel movements also subsided; however, her stools had become less regular. Functional status improved, with the patient able to walk for longer periods. Furthermore, the patient demonstrated objective improvements in spinal range of motion and biomechanics, with a marked decrease in tenderness to palpation. Repeat small-bowel follow-through following therapy demonstrated resolution of both narrowed areas (Figures 1B and 2B).

DISCUSSION

Conservative, non-operative management can be a viable approach to managing low-risk, symptomatic SBO; however, success varies with the etiology.[14] In the setting of adhesive partial SBO, a conservative approach has been shown to be successful in 65 to 80% of cases, with a relatively low overall incidence of ischemia ranging from 3 to 6%.

[15-19] While this approach is more tenuous in patients with complete SBO, some studies still report nonoperative management to be successful in 41 to 73% of these cases.[20] In all cases, failure of non-operative management quickly portends surgical intervention per current guidelines. In non-emergent cases, this is less than ideal for a multitude of reasons that include prolonged hospital stays, increased costs, and more frequent 30-day readmissions.[21]

Furthermore, intra-abdominal surgery is well-established as the most common etiology of adhesions, with subsequent interventions associated with increased risk.[22] Long-term benefits from this surgical approach are also unconvincing, with many patients reexperiencing abdominal pain only one year after surgery, often due to worsening or de novo formation of additional adhesions.

[23-25] In the present case, we reported the use of an innovative soft tissue therapy to treat a female with a one-year history of abdominal pain caused by two small-bowel narrowed areas secondary to surgically-induced adhesions. After 20 hours of intensive, individualized manual physical therapy performed over four consecutive days with a focus on deforming Leonard B Weinstock et al., IJCR, 2018 2:19 IJCR: http://escipub.com/international-journal-of-case-reports/ 0004 and detaching adhesive crosslinks, this patient experienced near complete resolution of her chronic pain that coincided with radiographic resolution of both of the previously identified small intestine strictures.

The clinical findings suggest that external adhesions were affecting the diameter of the neoterminal. Manual physiotherapy has been previously reported as successful in treating adults with a spectrum of adhesive pathologies spanning orthopedics, radiculopathy, and female infertility.[26 33] Furthermore, the manual physiotherapy regimen utilized in the current study, CPA, has previously been shown to be effective in disrupting adhesions, decreasing pain, and improving the overall quality of life in patients with recurrent SBO.

[34-37] CPA integrates techniques from an array of manual modalities to optimize individualized treatment, focusing intently on the patient’s specific areas of restriction. Application of a variety of sitespecific pressures across restrictive bands of adhered tissues and structures is employed, progressing from superficial to deep tissues.

[38] Furthermore, peri-visceral and interstitial adhesions are addressable via the CPA technique, while limited organ motility was treated using visceral manipulation.

[39] Ultimately, the CPA regimen is designed to facilitate the manual deformation of adhesions for increased mobility of affected tissues and organs. While focused on deforming and detaching fibrous adhesions, the non-invasive nature of this approach does not appear to promote new adhesive formation.

The current case discussion, in combination with the previously established success of sitespecific manual physiotherapy in treating a wide array of intra-abdominal adhesive pathologies, warrants further attention. The patient discussed here was scheduled for additional surgery and at risk for entering a perpetual cycle of symptom exacerbation, decreased quality of life, and adhesiolysis. Avoidance of this vicious predisposition in even a subset of patients holds significant value in alleviating a significant burden of comorbidity, cost, and healthcare resources.

Figure 1. A. Magnified spot image of the right lower quadrant from a small bowel follow-through with paddle compression demonstrates a short segment stricture of the neoterminal ileum [white arrow]; B. Overhead radiograph from a small bowel follow-through demonstrates resolution of the neoterminal ileal narrowing [white arrow] after physiotherapy. The time difference between images A and B is 6 months. Therapy was initiated five months after the initial small bowel radiography.

Figure 2. A. Overhead radiograph from a small bowel follow-through demonstrates a short segment stricture of the jejunum in the central abdomen [white arrow]; B. Overhead radiograph from a small bowel follow-through demonstrates resolution of the jejunal stricture in the central abdomen [white arrow].

LEARNING POINTS/TAKE-HOME MESSAGES

• Manual physiotherapy has been previously reported as successful in treating adults with a spectrum of adhesive pathologies.
• Adhesive SBO is preferably managed with conservative, non-operative therapy to minimize patient risk and cost.
• Physiotherapy may be a reasonable, nonoperative treatment for SBO patients once the acute obstruction has resolved.

PATIENT’S PERSPECTIVE

For me, Clear Passage was the last hope of avoiding surgery. The problem with surgery, in my case, is that it would only cause me to need more surgery in the future. Avoiding surgery was my top priority. I knew that if Clear Passage was my last hope, then it was worth trying. My week of therapy was relaxing for the most part. My therapist was very kind and did a good job explaining everything to me. Upon leaving, I was given instructions on at-home treatment to continue indefinitely. A month after receiving therapy, I had a follow-up x-ray, which proved that the therapy had, in fact, fixed my problem. That certainly made it to the list of one of the best days of my life. Eight months later, I continue to do the routine therapy at home. It does not take a lot of time, and it is not difficult.

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28. Şenbursa G, Baltaci G, Atay ÖA. The effectiveness of manual therapy in supraspinatus tendinopathy. Acta Orthop Traumatol. 2011;45:162-167.
29. Gaspar PD, Willis FB. Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskelet Disord. 2009;10:111.
30. Wurn BF, Wurn LJ, Patterson K, et al. Decreasing dyspareunia and dysmenorrhea in women with endometriosis via manual physical therapy: Results from two independent studies. J Endometr. 2011;3:188-196.
31. Wurn BF, Wurn LJ, King CR, et al. Treating fallopian tube occlusion with manual pelvic physical therapy. Altern Ther Heal Med. 2008;14:18-23.
32. Wurn BF, Wurn LJ, King CR, et al. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. Med Gen Med. 2004;6(2):51.
33. Kramp ME. Combined manual therapy techniques for the treatment of women with infertility: a case series. J Am Osteopath Assoc. 2012;112:680-684.
34. Rice AD, Reed ED, Patterson K, et al. Clearing bowel obstruction and decreasing pain in a Leonard B Weinstock et al., IJCR, 2018 2:19 IJCR: http://escipub.com/international-journal-of-case-reports/ 0007 terminally ill patient via manual physical therapy. J Palliat Med. 2013;16:222-223.
35. Rice AD, Wakefield LB, Patterson K, et al. Decreasing adhesions and avoiding further surgery in a pediatric patient involved in a severe pedestrian versus motor vehicle accident. Pediatr Rep. 2014;6(1):5126.
36. Rice A, King R, Reed E, et al. Manual physical therapy for non-surgical treatment of adhesion-related small bowel obstructions: two case reports. J Clin Med. 2013;2:1-12.
37. Rice AD, Patterson K, Reed ED, et al. Treating small bowel obstruction with manual physical therapy: a prospective efficacy study. Biomed Res Int. 2016;1:8.
38. 2011 GoOT. http://www.aacom.org/resources/bookstore/Documents/GOT2011ed.pdf

Lawrence J Wurn ¹, Belinda F Wurn ¹, Amanda S Roscow ¹, C Richard King ², Eugenia S Scharf ³, Jonathan J Shuster ⁴

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PMCID: PMC1480593  PMID: 15775874

Abstract

Context

Female sexual pain and dysfunction

Objective

To evaluate the effectiveness of a new site-specific, manual soft-tissue therapy in increasing orgasm and reducing dyspareunia (painful intercourse) in women with histories indicating abdominopelvic adhesion formation.

Design and Intervention

A total of 29 new patients presenting with infertility or abdominopelvic pain-related problems, and also indicating sexual pain or dysfunction, received a series of treatments (mean, 19.5 hours) designed to address biomechanical dysfunction and restricted mobility due to adhesions affecting the reproductive organs and adjacent structures.

Outcome Measures

Primary outcome measures were post-test vs pretest scores on: (1) the Female Sexual Function Index (FSFI) full scale, orgasm domain, and pain domain; and (2) 3 supplemental 10-point rating scales of sexual pain levels. Secondary outcome measures were post-test vs pretest scores in the other 4 FSFI domains (desire, arousal, lubrication, and satisfaction). The Wilcoxon signed-rank test was used for all statistical analyses.

Results

For the 23 patients available for follow-up, the paired FSFI post-test vs pretest scores were significant (P ≤ .003) on all measures. Of the 17 patients who completed the 3 sexual pain scales, the paired post-test vs pretest scores were significant (P ≤ .002)

Conclusions

Many cases of inhibited orgasm, dyspareunia, and other aspects of sexual dysfunction seem to be treatable by a distinctive, noninvasive manual therapy with no risks and few, if any, adverse effects. The therapy should be considered a new adjunct to existing gynecologic and medical treatments.

Introduction

In the course of treating female infertility with a manual physical therapy technique,[1] several of our patients volunteered the fact that they were having “the best sex, the best orgasms ever.” To determine the extent of this phenomenon, a question noting changes in orgasm intensity, frequency, and duration was added to the post-therapy outcomes section of the patient follow-up form. The response was sufficient to inspire further investigation.

The purpose of this study was to systematically assess the effectiveness of an innovative, site-specific, manual soft-tissue therapy in increasing orgasm and reducing dyspareunia (painful intercourse) in women with histories indicating abdominopelvic adhesion formation.

Assessing Female Sexual Dysfunction

Relatively recent investigations have found the prevalence of female sexual dysfunction (approximately 40%) to surpass that of males (approximately 30%).[2,3] Despite the higher prevalence, there have been few investigatory studies of female sexual problems and fewer available treatments than for comparable male conditions.[4]

Since the publication of the “Report of the International Consensus Development Conference on Female Sexual Dysfunction: Definitions and Classifications” in 2000, research has advanced. The committee built upon the existing frameworks (ie, the DSM-IV and ICD-10) and expanded its classifications to include both psychogenic and physiologic causes of arousal, desire, orgasm, and sexual pain disorders.[5] Thus, despite the fact that dyspareunia had long been considered to be psychogenic, it is now included in “Sexual Pain Disorders” due to its solid biological base (eg, connective tissue, hormonal, iatrogenic, inflammatory, muscular, neurologic, and vascular causes).[6]

Although there is still a lack of consensus regarding the definition and diagnostic framework for evaluating and treating female sexual dysfunction,[4] it has traditionally included a variety of (overlapping) disorders of desire/libido, arousal, lubrication, pain/discomfort, and inhibited (or total absence of) orgasm.[2] Many experts agree that the most authentic way of evaluating subjective sexual responses is in a naturalistic (ie, at home) setting, using a self-report technique.[4] Although earlier measures were largely unidimensional scales (eg, Hoon, Hoon, Wincze[7]), several newer multidimensional self-administered questionnaires have met the basic psychometric criteria for reliability and validity.[8] The Female Sexual Function Index (FSFI) is one of these.[4,8,9]

The FSFI, a 19-item questionnaire, assesses 6 key dimensions (domains) of sexual function in women, including orgasm and pain. The others are arousal, desire, lubrication, and satisfaction. The FSFI full score is obtained by adding the individual domain scores.

Etiology of Dyspareunia and Inhibited Orgasm

Painful sexual intercourse and inadequate (or absence of) orgasms are among the most common complaints of women seeking gynecologic care.[4,10]

Although psychological and interpersonal factors can contribute to all types of sexual dysfunction, physiologic factors play a large role in dyspareunia and orgasmic dysfunction. The causes of dyspareunia include a variety of organic factors, such as condyloma, ectopic pregnancies, endometriosis, pathologic conditions due to childbirth, pelvic inflammatory disease, postoperative scarring from gynecologic surgery, vaginal atrophy, vaginitis, and vulvar lesions.[10] Other etiologies include adnexal pathology; cystitis and interstitial cystitis; inadequate lubrication; pelvic adhesions, congestion, or infections; urethral disorders; vaginismus; and vulvodynia (vulvar vestibulitis).[11]

Genital pain during vaginal intercourse may occur upon initial or deep penetration, or both. Inadequate lubrication [pelvic floor dysfunction], vaginal atrophy, vaginismus, and vulvodynia are associated with painful entry. Deep pelvic pain occurs with the other conditions cited above[11] and may be due to the partner’s thrusting, which hits pain-sensitive structures. Myofascial restrictions and trigger points in the pelvic floor muscles can cause pain and may also serve as a trigger for neurogenic inflammation of the bladder wall.[12] We believe that many causes of dyspareunia (eg, clitoral and postsurgical adhesions, endometriosis, episiotomy scars, interstitial cystitis, vaginitis, and vulvodynia) may also affect orgasmic capability and overall sexual response.

Value of the Intervention

Clinically, we have observed that site-specific, manual soft-tissue therapy improves soft-tissue mobility, elasticity, and distensibility. Theoretically, mobilization of the soft tissue appears to break down the collagenous cross-links and adhesions that cause pain and dysfunction,[13] including dyspareunia and inhibited orgasm.

Adhesions and Female Sexual Dysfunction

Adhesions are deposits of fibrous tissue that form as a natural response to tissue injury after infection, inflammation, surgery, or trauma. In essence, they are bands of scar tissue with the potential to bind organs to other structures, which leads to multiple symptoms, including organ dysfunction and/or pain. Wherever they occur, adhesions distort the anatomy and can cause decreased mobility and function.[14] The pelvic organs and bowels are both common sites of adhesion formation, and many patients describe their pain as “pulling” or “stabbing.”

In addition to being a common outcome of pelvic or abdominal surgery, adhesions are known to accompany related conditions such as bowel obstruction, chronic abdominopelvic pain, endometriosis, pelvic inflammatory disease, pelvic spasms, polyps, and tubal obstruction.[15-17] It is presumed that some of these conditions cause, or are caused by, adhesions. It is also presumed that some cases of dyspareunia and orgasmic problems may be due to the formation of pelvic adhesions, imposing on pain-sensitive structures or altering pelvic biomechanics, including the positions of the pelvic support structures and viscera.

Adhesion Formation

Adhesions begin with a fibrin matrix that is formed as the body responds to tissue injury. In the first days following injury, multiple cellular elements become encased in this matrix. These are gradually replaced by vascular granulation tissue, containing fibroblasts, macrophages, and giant cells. Four days post-trauma, most of the fibrin is gone, and more fibroblasts and collagen are present. From Days 5 to 10, the fibroblasts align within the adhesions. By Day 14, the predominant cells present are fibroblasts. These fibroblasts anchor to adjacent collagen fibers and contract, shrinking the tissue.[18-20]

As the fibroblasts align within the structure, collagen is laid down in a haphazard manner, and cross-links begin to form. The result is the formation of a fibrinous adhesion, which may cause a subsequent adherence of the adjacent serosal surfaces. Tissue shrinkage leads to decreased movement of the area that, in turn, creates more mechanical irritation, thus perpetuating the cycle.[18-20] Four to 8 weeks after tissue damage, the collagen fibrils organize into discrete bundles. Eventually, the adhesion matures into a fibrous band. These mechanical components have been proposed as the underlying mechanism of adhesion-related pain.[21]

Manual Physical Therapy and Female Sexual Dysfunction

A search of the literature revealed a dearth of research on the use of manual physical therapy for treating female sexual dysfunction.[1] Most dyspareunia studies focus on its prevalence; treatment information is generally limited to surgical options and psychosocial components.[10] Thus far, we have found only 1 relevant case report. In this instance, the therapist employed soft-tissue mobilization, myofascial release, muscle energy techniques, biofeedback, strengthening and stabilizing exercises, and an orthotics consult to successfully treat dyspareunia in a 42-year-old woman (who also reported abdominal and low back pain). The patient was seen for a total of 31 hours over 1 year.[10]

Methodology

Subjects

Selection

All clinic patients were required to complete a 6-page standard Patient Intake Questionnaire detailing their pain and medical history. Those patients who indicated dyspareunia and sexual dysfunction on the questionnaire (or during their initial evaluation) were asked if they were willing to participate in a research study. Criteria for inclusion were as follows:

1. Indication of painful intercourse and/or difficulty or inability to orgasm;
2. Willingness to complete a pre-and post-treatment questionnaire on sexual pain and dysfunction; and
3. A history indicating likely adhesions due to infectious or inflammatory processes, miscarriage, abdominal and/or pelvic surgery, or trauma within the abdominopelvic area.

A total of 29 women were selected to receive a series of site-specific, manual physical therapy treatments for abdominopelvic pain or dysfunction. Six patients were lost to follow-up.

Gynecologic History

All 23 patients in this study had proven or clinically well-supported suspicion of adhesions. Medical diagnoses included:

Characteristics

Study participants were a multiethnic, primarily white group, ranging in age from 25 to 43 years; mean = 33.8 years. The patients were being treated for various types of abdominopelvic pain or dysfunction, including infertility.

Procedures/Interventions

The primary goals of manual therapy are to decrease pain and restore mobility by improving soft-tissue mobility, elasticity, and distensibility. The intent of the manual physical therapy protocol used in this study was to create microfailure of collagenous cross-links, the “building blocks” of adhesions. These unique soft-tissue techniques were developed after extensive study of current, innovative, manual physical therapy methods.

Theoretically, mobilization of the soft tissue may break down collagenous cross-links and adhesions that can cause pain and dysfunction,[13] including dyspareunia and inhibited or absent orgasms. Thus, following a thorough medical, gynecologic, and surgical history and palpatory assessment of the patient’s abdomen and pelvis, specific areas of visceral and myofascial cross-linking were determined to be likely adhesion sites due to their restricted mobility.

Focusing on these areas of decreased mobility, the therapist engaged the soft tissues until cross-links were perceived to release. This release was evidenced by increased mobility at the precise sites of visceral and myofascial restrictions after each therapy session. The changes were further demonstrated by improved alignment, biomechanics, and increased range of motion of osseous and soft-tissue structures (eg, improved pelvic floor musculature tone, decreased pelvic floor spasms).

Our professional staff has developed literally hundreds of techniques to address the various conditions and complaints reported by our patients and/or noted by the therapists. A typical technique, shown in Figure 1, is designed to decrease spasm and adhesions between the uterus and the bladder.

As shown in this example, the therapist engages the uterine fundus and sidewalls and tractions them to the left. To assist and improve the mobility of the soft tissues, the therapist may release the tension of the traction either suddenly or gradually, depending on the desired effect.

In accord with the standards of the American Physical Therapy Association, detailed clinical records were kept of each patient’s visit, including treatment dates and duration, symptomatic complaints, areas treated, and treatment techniques performed.[22] Depending on the patient’s schedule and geographic location, the frequency and duration of treatment ranged from 2 hours per week for 2+ months to intensive sessions of 2 to 4 hours of treatment daily, performed over 5 days. The standard length of each therapy session was 1 to 2 hours, minus 15 minutes for room preparation and paperwork.

A total of 20/23 (87.0%) patients received the recommended 20 hours of treatment; mean = 19.5 hours. None of the patients received concurrent infertility or pelvic pain therapies during the treatment or 6-week follow-up period.

Data Collection

Study patients were evaluated and treated between October 2002 and January 2004. Since the purpose of this study was to determine the effectiveness of manual soft-tissue therapy in treating female sexual dysfunction — specifically, increasing orgasm and decreasing dyspareunia — the data set consisted of the pretreatment and post-treatment scores on 2 assessments of these factors.

1. The Female Sexual Function Index (FSFI), a 19-item questionnaire, was developed in 2000 as a brief, multidimensional self-report instrument for assessing the key factors of sexual function in women. It is easy to administer and psychometrically sound in terms of reliability (test-retest and internal consistency) and construct validity. The FSFI was designed and validated for use in clinical trials or epidemiologic studies. Thus far, it has been validated on clinically diagnosed samples of women with female sexual arousal disorder, female orgasmic disorder, and in women with hypoactive sexual desire disorder.[4,8,9]

The FSFI comprises 6 key dimensions or domains, including orgasm, pain, arousal, desire, lubrication, and satisfaction. The individual domain scores are derived by adding the scores of the individual items constituting the domain and multiplying the sum by the domain factor. The full FSFI score is obtained by adding the 6 individual domain scores.[4]

According to the FSFI authors, “sexual response involves a temporal sequencing and coordination of several phases.” Thus, problems in one area may interact with those in another, resulting in a substantial overlap among the diagnostic categories. The FSFI has been designed to assess the relative severity of dysfunction within each domain.[4]

A typical item on the FSFI is Q12:

Over the past 4 weeks, when you had sexual stimulation or intercourse, how difficult was it for you to reach orgasm (climax)?

Response Options:

0 = No sexual activity

1 = Extremely difficult or impossible

2 = Very difficult

3 = Difficult

4 = Slightly difficult

5 = Not difficult

[Note: The complete FSFI questionnaire, instructions, and scoring algorithm can be obtained at www.FSFIquestionnaire.com.]

2. Three 10-point scales assessing best, worst, and average pain levels during sexual intercourse were based upon the standard 10-point pain scales used to quantify subjective pain complaints. They were intended to supplement the 3 items representing the pain domain in the FSFI. The worst-best-average nomenclature permitted increased specificity for patients reporting painful intercourse.

The directions for the pain scales (listed as item 20 on the patient pretest and post-test) were simply as follows:

With zero being no pain and ten being the worst pain you could imagine, rate (circle) your own pain levels associated with sexual intercourse over the last four weeks.

My worst pain level during sexual intercourse

1   2   3   4   5   6   7   8   9   10

My best pain level during sexual intercourse

1   2   3   4   5   6   7   8   9   10

My average pain level during sexual intercourse

1   2   3   4   5   6   7   8   9   10

Administration

Since the questionnaire items asked the subjects to rate their responses “over the past 4 weeks…,” the pretest was administered at or near the beginning of the actual treatment sessions. The post-test was completed 6 weeks after the last treatment date, thereby allowing 2 weeks post-treatment for the body to assimilate the changes. The post-test was mailed to the patients in a prestamped envelope the previous week. None of the patients had a copy of their pretest responses.

Although all 23 patients completed all 19 items of the FSFI pre-and post-tests, 6 were eliminated from the pain scale analysis due to incomplete data.

Statistical Method

The Wilcoxon signed-rank test[23] was used on the paired difference post-test/pretest for the values where high scores are good (Table 1), and pretest minus post-test, where high values are unfavorable (Table 2). Since the questionnaires yielded ordinal (qualitative ranking) data, medians and quartiles are provided in lieu of means and standard deviations.

Table 1.

FSFI Full and Domain Scores (N = 23)

Table 2.

10-point Pain Scale Scores* (N = 17)

Results

For purposes of evaluating the effectiveness of site-specific, manual soft-tissue therapy in increasing orgasm and reducing dyspareunia in women with a history indicating probable abdominopelvic adhesions, the primary positive clinical outcomes were defined as improvements on the post-test vs pretest scores on (1) the FSFI full scale, orgasm domain, and pain domain; and (2) the 3 supplemental 10-point scales of sexual pain (worst-best-average).

Although the FSFI was designed to assess the relative degree of dysfunction within each domain, there is a substantial and unavoidable overlap among the diagnostic categories.[4] Thus, secondary positive clinical outcomes were defined as improvements on the post-test vs pretest scores in the other 4 domains of the FSFI (desire, arousal, lubrication, and satisfaction).

In terms of the primary outcome measures, there was a statistically significant improvement on the FSFI full score (P < .001), pain domain (P < .001), and orgasm domain (P < .001) (see Table 1. Indeed, 21 of the 23 patients showed improvement on the FSFI full score. There was also a significant improvement on all 3 pain scales: worst pain (P < .001), best pain (P = .002), and average pain (P < .001) (see Table 2).

In terms of the secondary outcome measures, statistically significant differences in post-test/pretest scores were found on the other 4 FSFI domains: desire (P < .001); arousal (P = .0033); lubrication (P < .001), and satisfaction (P < .001), see Table 1.

[Note: The footnotes to the tables provide the “improved/worsened/tied” data for the 6 FSFI domains and 3 pain scales.]

Discussion

Since the causes of dyspareunia and orgasmic capacity include a number of adhesion-related physiologic factors (eg, inflammation, infection) [10], it is not surprising that a site-specific, manual soft-tissue therapy designed to treat these would prove so effective. Pain and orgasm represent 2 (ie, one-third) of the 6 domains comprising the FSFI; thus, it follows that improvements in these would automatically result in improved overall sexual function, as evidenced on the post-test FSFI full score.

On the other hand (and despite the known overlap in the diagnostic dimensions of female sexual functioning), it was surprising to find that the therapy apparently effected equally significant improvements on all quantifiable domains of this complex phenomenon, including desire, arousal, lubrication, and satisfaction. The unforeseen effectiveness of a manual physical therapy technique upon all 6 FSFI domains clearly supports the view that the “psychobiology of the experience of sexual pain”[6] and orgasm needs to be addressed from a comprehensive perspective.

Future Research

These exceptionally encouraging results raise 2 immediate questions: (1) How would this distinctive protocol compare with a more traditional type of massage therapy (eg, Swedish) in treating women with sexual dysfunction? (2) Could this specific therapy also benefit women lacking strong indications of adhesion formation?

Accordingly, 2 planned studies of sexual dysfunction will have much larger samples of subjects, randomized into experimental (treatment) and control (“standard massage”) groups. The studies will test the hypothesis that this distinctive protocol of site-specific, manual soft-tissue treatment is superior to traditional massage therapy in treating sexual dysfunction in women with and without histories of abdominopelvic adhesions.

Subsequent studies will investigate the relative efficacy of the therapy on different types of dyspareunia; ie, painful entry vs deep pain during sexual intercourse.

Conclusion

The results of the present study suggest that many cases of orgasm dysfunction and dyspareunia are treatable by a distinctive site-specific protocol of manual soft-tissue therapy. The treatment also seems to improve other aspects of sexual dysfunction, including desire, arousal, lubrication, and satisfaction. The therapy, designed to maximize function by restoring visceral, osseous, and soft-tissue mobility, is a nonsurgical, noninvasive technique with no risks and few, if any, adverse effects. As such, it should be considered a new adjunct to existing gynecologic and medical treatments of sexual pain and dysfunction.

Acknowledgments

We would like to thank Emily F. Hoon, PhD, and Marvin H. Heuer, MD, for encouraging us in this endeavor. We also thank Cynthia Hodgson, PT, PhD; Kimberley Hornberger, PTA; and Amy B. Hough for their many valuable contributions.

Footnotes

Corresponding Author: L.J. Wurn, Clear Passage Therapies, 3600 NW 43rd Street, Suite A-1, Gainesville, FL 32606. www.clearpassage.com.

Contributor Information

C Richard King, Florida Medical and Research Institute, P.A., Gainesville.

Eugenia S Scharf, medical writer/researcher, Gainesville.

Jonathan J Shuster, Department of Statistics, College of Medicine, University of Florida, Gainesville.

References

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Belinda F Wurn ¹, Lawrence J Wurn ^1,✉, Kimberley Patterson ¹, C Richard King ², Eugenia S Scharf ³

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PMCID: PMC6154826

Purpose

To assess the efficacy of a non-invasive, site-specific manual physiotherapeutic technique in ameliorating dyspareunia and dysmenorrhea, commonly associated with endometriosis, by performing a retrospective and prospective analysis, respectively.

Methods

Human female subjects, all surgically diagnosed with endometriosis, were enrolled in each of the studies post-informed consent. Each subject underwent 20 hours of site-specific manual physical therapy (Wurn Technique) designed to address adhesions and restrictions in soft tissue mobility in the abdomen and the pelvic floor. The post-test was completed 6 weeks after treatment. Evaluation incorporated outcome prediction based on Female Sexual Function Index (FSFI) for analyzing the effect on dyspareunia and sexual function (n=14) and quantitative differences in ratings of average pain during menstrual cycle and intercourse based on the Mankoski Pain Scale for analyzing the effect on dysmenorrhea and dyspareunia (n=18), respectively. Data was analyzed by the Wilcoxon signed-rank test (two-sided).

Results

FSFI Full Scale score showed overall statistically significant improvements (P=.001) for all domains of sexual function, including dyspareunia (P<.001) in the retrospective analyses. Mankoski Pain Scale exhibited statistically significant improvements in menstrual cycle (P<.014), dysmenorrhea (P=.008), and dyspareunia (P=.001) in the prospective analyses.

Conclusion

Site-specific manual physiotherapy might offer a non-pharmacologic and non-surgical alternative in the treatment of dyspareunia and dysmenorrhea in endometriosis patients. Further randomized, blinded, and multicenter assessment of the technique is warranted to validate the results and gauge any potential pitfalls.

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In a previous publication, our group presented 2 small cohort studies that assessed the improvements in endometriosis-associated pain, specifically dyspareunia and dysmenorrhea (1). These patients were treated with manual physiotherapy (Wurn technique) at a private physical therapy clinic. Following the publication of the study in 2011, we conducted additional follow-up on the patients presented in Study II to assess the longevity of the improvement in dyspareunia and dysmenorrhea symptoms. A total of 7 of the 18 original patients from the prospective study were available for follow-up at 4 and 12 months posttreatment. Patients ranked their level of pain with menstruation and intercourse over the previous 4 weeks from 0 to 10 using the Mankoski pain scale. The age range of patients available for long-term follow-up was 31-41 years (mean 36.2, median 37.5), comprising a similar demographic to the original treatment group.

In the original study, there were significant decreases in both dyspareunia and dysmenorrhea observed at 6 weeks posttreatment via the Wilcoxon signed rank test. In addition, the patients available for follow-up maintained their improvements in both dyspareunia and dysmenorrhea at 4 and 12 months following treatment as compared with pretreatment values. Significant improvements in dysmenorrhea throughout both 4 and 12-month follow-up time points were observed. There were also significant improvements in dyspareunia at the 4-month follow-up (Fig. 1), with the average pain rating for dyspareunia at 12 months lower than before treatment, but not significantly so. It is interesting to note that dyspareunia was reported to have returned to the pretreatment intensity by 3 of 7 patients, while 3 of 7 patients with pretreatment dyspareunia reported no pain with intercourse posttreatment. No patients reported an increase in dyspareunia following treatment.

Current data from endometriosis patients who undergo surgical intervention for pain show they experience approximately 12 months of reduced pain levels that gradually return after the surgery (2, 3). Although the follow-up from this original study had a limited number of subjects, the long-term results support the subjective observations from patients that the decrease in pain was maintained for 12 months after treatment.

This finding is important for both physicians and patients to identify additional options for minimally invasive, low-risk, first-line treatment for manual physiotherapy to address dyspareunia and dysmenorrhea. In an effort to identify predictors for positive outcomes with this manual physiotherapy, future research studies will assess a larger cohort of subjects for immediate and long-term improvements in dyspareunia and dysmenorrhea, focusing on patients with endometriosis, stratified by stage.

Financial Support: No support was received for this study.Conflict of Interest: B.F.W. and L.J.W. are sole shareholders of Clear Passage Physical Therapy. C.R.K. has no significant financial interests in this report. A.D.R. and K.P. are employed by Clear Passage Physical Therapy.

Amanda D. Rice, Kimberley Patterson, Belinda F. Wurn, C. Richard King, Lawrence J. WurnClear Passage Physical Therapy, Gainesville, Florida – USAAddress for correspondence: Lawrence J. Wurn4421 NW 39th Ave, Suite 2-2Gainesville, FL 32606, USAlarryw@clearpassage.com

Belinda F Wurn ¹, Lawrence J Wurn ^1,*, Amanda S Roscow ¹, C Richard King ², Marvin A Heuer ³, Eugenia S Scharf ⁴, Jonathan J Shuster ⁵

• Author information
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PMCID: PMC1395760  PMID: 15266276

Abstract

Context

Infertility and pregnancy.

Objective

To assess the effectiveness of site-specific manual soft tissue therapy in (1) facilitating natural fertility and (2) improving in vitro fertilization (IVF) pregnancy rates in women with histories indicating abdominopelvic adhesion formation.

Design and Intervention

Pursuant to 2 promising pilot studies, 53 infertile, premenopausal patients received a 10- to 20-hour series of site-specific manual physical therapy treatments. Seventeen patients hoped to achieve a natural pregnancy; 36 planned to undergo IVF within 15 months. The primary criteria for inclusion in the studies were the inability to conceive following a minimum of 12 months of unprotected intercourse and suspected or confirmed pelvic adhesions due to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), or trauma. Treatments were specifically designed to address biomechanical dysfunctions of the pelvis, sacrum, and coccyx, and restricted soft tissue and visceral mobility due to adhesions or microadhesions affecting the reproductive organs and adjacent structures.

Main Outcome Measures

(1) Natural fertility group: pregnancy within 1 year of therapy and subsequent full-term delivery; (2) Pre-IVF group: pregnancy (via transfer of fresh embryos from nondonor eggs) within 15 months of the last manual treatment date.

Results

Natural Fertility Group

Of the 14 patients available for follow-up (ages 25 to 44; mean, 33.5 years), 10 (71.4%) became pregnant within 1 year, and 9 (64.3%) reported full-term deliveries. Three of the 9 women who delivered reported a subsequent pregnancy, suggesting that the treatment protocol might have lasting effects. Two women have had a second live birth delivery, and the third is still pregnant.

Pre-IVF group

Of the 25 patients available for follow-up (ages 28 to 44; mean, 36 years), clinical pregnancies were documented in 22 of 33 embryo transfers vs the US Centers for Disease Control and Prevention (CDC) 2001 age-adjusted expected number of 12.7 (P < .001). The estimated odds ratio for a successful pregnancy in a cycle (manual treatment: no treatment) is 3.20 (95% confidence interval = 1.55–8.4).

Conclusions

The data trend across these studies suggests that this innovative site-specific protocol of manual soft-tissue therapy facilitates fertility in women with a wide array of adhesion-related infertility and biomechanical reproductive organ dysfunction. The therapy, designed to improve function by restoring visceral, osseous, and soft-tissue mobility, is a nonsurgical, noninvasive manual technique with no risks and few, if any, adverse side effects or complications. As such, it should be considered a new adjunct to existing medical infertility treatments.

Introduction

The purpose of the present series of investigations was to assess the effectiveness of site-specific manual soft-tissue therapy in treating infertility in women with a history indicating probable abdominopelvic adhesion formation, eg, prior surgery, endometriosis, infection, inflammatory process, trauma, or tubal obstruction.

Adhesions and Infertility

In the United States, infertility is defined as the inability to conceive after 12 months of unprotected sexual intercourse.[1,2] Internationally, the time frame is generally longer — 24 months.[3] Infertility is a common problem affecting 10% to 15% of heterosexual couples. Estimates suggest that 40% of the problems are attributable to the female, 40% to the male, 20% to both or unknown, and that some 25% of infertile couples have > 1 factor impeding fertility.[3] As most infertility research lacks control couples for comparison, much of the infertility literature is anecdotal.[4]

Of the approximately 5 million infertile women in the United States, it is estimated that 2 million (40%) have medical or hormonal infertility; 1 million (20%) have idiopathic infertility; and 2 million (40%) have mechanical infertility.[5]

Pelvic adhesions are often cited among the primary causes of mechanical infertility.[4,6] Adhesions are deposits of fibrous tissue that form as a natural inflammatory response to tissue damage after surgery, infection, inflammation, or trauma. They form as a by-product of the healing process and may remain long after the original site of inflammation or trauma has healed. They may adhere to a specific organ or muscle, either within the myofascial structure of the organ, on its surface, or as an attachment to neighboring structures. Wherever they occur, adhesions distort the anatomy and cause decreased mobility and function.[4]

In addition to being a common outcome of pelvic surgery, the formation of pelvic adhesions is known to accompany related conditions such as endometriosis, pelvic inflammatory disease (PID), tubal obstruction, polyps, pelvic spasms, bowel obstruction, and chronic abdominopelvic pain.[6–8] It is presumed that some of these dysfunctions cause, or are caused by, adhesions. Moreover, a certain proportion of idiopathic infertility may be due to microadhesions that have formed in the pelvis as the body healed from a previous inflammation or trauma. Microadhesions are often too small to see and thus difficult to diagnose.

Effects of Abdominopelvic Adhesions

In sum, adhesions can restrict the mobility and function of the organs, ligaments, osseous structures, muscles, fascia, and nerves. Thus, they affect the biomechanics of the entire abdominopelvic region, limiting the ability to conceive even with in vitro fertilization (IVF) and other assisted reproductive technologies (ART).

Infertility-causing adhesions may form in the following locations:

• on uterine walls and ligaments, increasing the possibility of uterine spasm, implantation problems, and miscarriage, and decreasing the ability to conceive;
• at and within the tissues of the cervix, creating stenosis, affecting the relaxed midline position, contributing to uterine spasms, and complicating sperm transfer to the uterus;
• on the surface of the ovaries, preventing exposure of the ovum and making transfer to the fallopian tube difficult;
• at the distal aspect of the fallopian tube, restricting the tentacle-like grasping of the egg by the fimbria, hence increasing its risk of being wasted in the abdominal cavity; and
• anywhere on the inside or outside of the fallopian tube, causing partial or total tubal occlusion, decreasing the probability of conception, and increasing the chance of an ectopic pregnancy.[9–11]

Value of Intervention

Clinically, we have observed that site-specific manual soft-tissue therapy improves soft-tissue mobility, elasticity, and distensibility. Theoretically, mobilization of the soft tissue may break collagenous cross-links and adhesions that cause pain and dysfunction,[12] including physician-diagnosed mechanical infertility.

In addition to its apparent use as a natural infertility treatment, this therapy functions as an adjunct to regular gynecologic care when applied before intrauterine insemination (IUI) and IVF. We suspect that the therapy specifically helps improve mobility and motility of the reproductive organs by decreasing the following:

• adhesions and microadhesions on and within the uterine walls, helping to create a more hospitable surface for implantation;
• uterine and cervical hypertonicity and spasm, thus creating a more relaxed environment for implantation;
• cervical stenosis, adhesions, and tensions within the cervix and its attachments, thus improving cervical mobility and facilitating transfer to the preferred implantation site.

Connective Tissue and Adhesions

The ability of manual therapy to affect connective tissues and adhesions has been supported in the basic literature on mechanical tissue testing and connective tissue physiology and remodeling. Specific sustained physical forces applied to a given area alter connective tissue length and mobility.[13]

Adhesion formation occurs after soft-tissue trauma and is caused by an inflammatory response to tissue damage. The body responds to injury by activating macrophages to debride and clean the damaged area. Fibroblasts begin to replace lost collagen, producing a fibrinous exudate. Myofibroblasts then appear, anchor to adjacent collagen fibers, and contract, thus shrinking the tissue.[14–17]

As collagenous fibroblasts align within the structure, collagen is laid down in a haphazard manner, and cross-links begin to form. The result is the formation of a fibrinous adhesion, which may cause a subsequent adherence of the adjacent serosal surfaces. Tissue shrinkage leads to dysfunctional movement of the area that, in turn, creates more mechanical irritation, thus perpetuating the cycle.[14–17] These mechanical components have been proposed as the underlying mechanism of adhesion-related pain.[18]

As healing time increases, cross-links may grow into microadhesions, then adhesions, and eventually thicken into scars.[15,16] Minor adhesion formations are often limited and may be absorbed within a few days by fibrinolytic mechanisms, but permanent adhesions can form between the peritoneum and the serosal surface of adjacent organs. These permanent adhesions are considered a pathologic state in which the continuous unity of the peritoneal wall or serosal surface of organs is destroyed, leading to impairment of their physiologic functions.[19,20] Mobilization of the soft tissues using site-specific manual therapy appears to break the attachments of the collagenous cross-links within the adhesions, thus restoring normal mobility and function to the previously adhered organs.

Physical Therapy and Infertility

A search into the use of manual physical therapy as an infertility treatment yielded a series of studies conducted between 1978 and 1989 in the Czech Republic. The Mojzisovà method includes a combination of soft tissue and osseous mobilization techniques, post-isometric relaxation, and a home exercise program over a 6-month treatment period. It is based on the premise that accidents (including falls) and sedentary lifestyles can cause blockages or constrictions in the lower spine that lead to pelvic spasms and other functional disturbances of the pelvic region. Thus, according to Mojzisovà, “there is a direct relationship between the condition of the lower back muscles and the way the reproductive organs function.”[21,22]

The purpose of the second Prague study, based on 2006 randomly selected infertile women, was to determine which types of infertility were best suited for treatment by the Mojzisovà method. Results showed that conception rates ranged from a low of 11% for women aged 40 to 44 to a high of 46% for the age group 20 to 24. Other factors increasing the chance of success included an active lifestyle and the absence of tubal obstructions and other intrusive conditions, such as PID, abdominal and/or pelvic surgery, and ectopic pregnancy.[21]

A subsequent study (1987 to 1989) based on the above findings compared the Mojzisovà method with several control treatments. Criteria for participation were as follows: (1) age between 22 and 30 years; (2) normal quality/quantity of partner’s sperm; and (3) patency of fallopian tubes. The study population included 166 women whose mean duration of infertility was 4 years; 118 women completed the trial. The mean conception rate for the main experimental group was significantly higher than that for the 3 control groups, who either performed “non-genuine” exercises or did not exercise at all – 34.3% (12/35) vs 8.4% (7/83) (P < .01).[22]

Pilot Studies

Pilot Study #1 (1989 to 1992)

Facilitating fertility through this site-specific soft-tissue therapy originated as an unplanned outcome of treating physical therapy patients for a variety of pelvic pain symptoms in areas where decreased tissue mobility was noted. In brief, 4 previously infertile women became pregnant coincidentally with their treatment. Two of the women, aged 28 and 42, reported infertility as a result of bilateral tubal occlusion; they had been trying to conceive for 7 and 10 years, respectively. Their treatment protocols had been designed to decrease pain and increase function by breaking adhesive cross-links at specific sites in the abdominal and pelvic regions of the body. All 4 pregnancies resulted in full-term deliveries, and 1 woman reported a subsequent full-term pregnancy and live birth. As a retrospective review of these cases, documented through clinical observation, patient reports, and gynecologic records, Pilot Study #1 was the first test of the hypothesis that the therapy could facilitate fertility in previously infertile women.[23]

Pilot Study #2 (1995 to 1997)

In a delayed attempt to substantiate the results of Pilot Study #1, a prospective study with 4 new patients was conducted. To test the hypothesis that the therapy could decrease adhesions and therefore improve reproductive organ function, Pilot Study #2 required bilateral tubal occlusion, diagnosed by pre- and posttreatment hysterosalpingogram (HSG), laparoscopy, and/or laparotomy. Although 2 patients showed no change in patency after treatment, the third patient exhibited 1 patent tube, and the fourth demonstrated 1 patent tube and 1 improved tube.[23]

Figures 1 and 2 depict pretreatment and posttreatment HSGs for a 34-year-old woman with no prior pregnancies who had been infertile for 8 years. She was referred to physical therapy with a history of bilateral occlusion with hydrosalpinx, as diagnosed by chromotubation during laparoscopy and laparotomy. Further support for this diagnosis was provided by 2 separate pretreatment HSG studies approximately 1 year apart. In a posttreatment HSG, 1 tube demonstrated free spillage of contrast dye, and the contralateral tube was improved with increased migration of the dye (ie, the contrast medium filled more of the ampullary portion of the contralateral tube).[23]

Figure 1.

Pretreatment HSG for a 34-year-old woman: bilateral tubal occlusion with left hydrosalpinx. Diagnosis was consistent with pretreatment laparoscopy and laparotomy.

Figure 2.

Posttreatment HSG: persistent hydrosalpinx with increased migration of the dye in the left tube; free spillage of contrast via the right tube.

The promising results obtained in Pilot Studies #1 and #2 suggested the methodology for the 2 subsequent studies included in this article: I. Facilitating Natural Fertility, and II. Improving IVF Pregnancy Rates.

Studies I and II (1998 to 2003)

Although each study is separately presented below, many subject characteristics and the intervention itself are common to both. Patient histories were obtained from medical records and included physical therapy and biomechanical assessments; gynecologic, surgical, and trauma histories; and prior infertility tests, diagnoses, and treatments.

Subject Selection

Presence of Adhesions

The purpose of the 2 studies was to assess the effectiveness of site-specific manual soft-tissue therapy in treating biomechanical infertility in women with probable abdominopelvic adhesion formation. Thus, all enrolled subjects had histories of conditions indicating a strong probability of adhesion formation before treatment (ie, abdominal and/or pelvic surgery, infectious or inflammatory disease, or trauma). Moreover, 48.7% of patients had definite diagnoses of “adhesions” affecting the reproductive and/or neighboring structures. Although it seemed unlikely that manual soft-tissue therapy would have a direct effect on patients also having medical or hormonal infertility, no patient was excluded from the studies for these conditions.

Medical Histories

The relevant medical histories for the subjects in the 2 studies include the following:

• Gynecologic: Abdominopelvic pain, abortion, adhered ovaries at fimbriae, adhesions (abdominal, pelvic), bicornuate uterus, bladder infection, C-section, chronic pelvic inflammation, chlamydia, cystitis, D&C, dysmenorrhea, dyspareunia, ectopic pregnancy, endometriosis, failure to ovulate, fibroids, hydatid cyst of Morgagni at tube, hydrosalpinx, interstitial cystitis, irregular menstrual periods, multiple miscarriage, partially blocked and adhered tubes, numbness at C-section scar, ovarian cysts, PID, pelvic scarring, polyps in uterine horn, ruptured cyst, thyroid and hormonal problems, uterine prolapse, tubal occlusion (unilateral, bilateral), tubal phimosis, urinary incontinence, and vaginitis.
• Surgical: Abdominal, abortion, appendectomy, bladder repair, C-section, cervical, D&C, episiotomy, fibroidectomy, hysteroscopy, laparoscopy, laparotomy, lysis of adhesions, myomectomy, ovarian cystectomy, pelvic, tuboplasty, and uterine suspension.
• Trauma: Broken bones; falls; injuries to the low back, hip, pelvis, sacrum, and coccyx; car accidents; and physical and sexual abuse.
• Prior infertility tests and diagnoses: Infertility tests included gynecologic physical examinations and cultures, FSH and TSH tests, ultrasound, HSG, laparoscopy, and laparotomy. Some patients also had hysteroscopy, endometrial, and peritoneal biopsies. Infertility diagnoses included hormonal problems, total bilateral occlusion, unilateral occlusion with contralateral tube partially blocked, and hydrosalpinx.
• Prior infertility treatments: In addition to HSG, laparotomy, laparoscopy, and hysteroscopy (used primarily for diagnosis), prior infertility treatments included surgery (see above); pharmaceuticals (ie, clomiphene [Clomid], estradiol, FSH, gonadatropins [Lupron], menotropin [Repronex], micronized progesterone [Prometrium]); and assisted reproductive techniques (ie, IUI and IVF).

The Intervention

The primary goals of manual therapy are to decrease pain and restore mobility. The intent of the particular therapy used in this study is to create microfailure of collagenous cross-links, the “building blocks” of adhesions. These unique soft-tissue techniques were developed after extensive study of current, innovative physical therapy methods.

Following a thorough medical, gynecologic, and surgical history, specific sites of visceral cross-linking were deduced as likely adhesion sites. The therapist also employed sufficient palpation and evaluation skills to note areas of decreased mobility. The restricted soft tissues were engaged, and cross-links were perceived to release as evidenced by increased mobility at the precise sites of visceral and myofascial restrictions after each therapy session.

After a perceived increase in histologic length (presumably due to deformation of collagenous cross-links), the soft tissues were noted to become more pliable, with increased mobility and flexibility. These changes were further demonstrated by improved alignment, biomechanics, and increased range of motion of osseous and soft-tissue structures. Many patients reported a decrease in pain symptoms, presumably as a result of decreased pressure on nerves and pain-sensitive structures.

In accord with the standards of the American Physical Therapy Association, detailed clinical records were kept of each patient’s visit, including treatment dates and duration, symptomatic complaints, areas treated, and treatment techniques performed.[24] Depending on the patient’s schedule and geographic location, the frequency and duration of treatment ranged from a 1-hour session at weekly or longer intervals to intensive sessions of 2 to 4 hours of treatment daily, performed over 5 days. The standard length of the therapy sessions was 1 to 2 hours, minus 15 minutes for room preparation and paperwork.

Study I. Treating Female Infertility With a Manual Physical Therapy Technique

Subjects

Selection

The primary criteria for inclusion in this prospective study were (1) the inability to conceive following at least 12 months of unprotected intercourse, and (2) suspected or confirmed pelvic adhesions attributed to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), miscarriage, or trauma within the abdominopelvic area. A total of 17 women were selected to receive a series of site-specific manual physical therapy treatments; 3 were lost to follow-up.

Gynecologic History

All 14 patients in this study had proven or clinically well-supported suspicion of adhesions. Medical diagnoses included:

Characteristics

Study participants were a multiethnic, primarily white group, ranging in age from 25 to 44 years. The mean age was 33.5 (median, 32), and the duration of infertility ranged from 1 to 20 years, with a mean of 4.9 (median, 4) years.

Procedures/Intervention

Largely on the basis of standard physical therapy practices, completion of a minimum of 20 treatment hours (or pregnancy during the course of therapy) was one of the few criteria for inclusion in the study.[24] None of the patients received concurrent infertility therapies during the treatment period.

Data Collection

Study patients were evaluated and treated between May 1998 and February 2002 and tracked for at least 1 year following therapy. This does not imply that failure to become pregnant within a year was deemed permanent infertility,[4] but in terms of facilitating fertility in a timely manner, 1 year sufficed for outcome assessment. Patients who became pregnant during treatment were tracked through the expected delivery date. Follow-up data were obtained via questionnaires, telephone calls, letters, and email.

The final data set includes 14 patients who completed the recommended 20 hours of therapy or else became pregnant before completing therapy. Three patients were omitted because they did not respond to follow-up attempts.

Results

For purposes of evaluating the effectiveness of site-specific manual soft-tissue therapy in facilitating fertility in women with a history indicating probable abdominopelvic adhesion formation, positive clinical outcomes were defined as (1) natural pregnancy within 1 year of the last treatment date, and (2) subsequent full-term delivery.

The duration of therapy was 1 to 24 weeks; median hours of therapy, 11. Of the 10 subjects who became pregnant, 9 conceived before receiving the full 20 hours of therapy. Having achieved their objective (pregnancy), continued treatment was deemed unnecessary.

As shown in Table 1, 10 of the 14 study participants (71.4%) demonstrated posttreatment pregnancy, and 9 of 14 (64.3%) subsequently delivered a full-term baby. Hence, 90% (9/10) of the women who conceived had a live birth delivery, including 3 patients who had reported unilateral or bilateral tubal occlusion. The one “unsuccessful” patient (age 32) lost her baby at 28 weeks of gestation because of umbilical cord strangulation.

Table 1.

Pregnancies and Full-term Births

® 9/10 (90%) subjects who conceived had a full-term delivery.

Various studies over the decades have unequivocally demonstrated the statistically significant decline in female fertility with age. Indeed, as one expert claims, “a woman’s 35th birthday marks a watershed that irreversibly lowers the probability of reproduction in her life.”[4] The 1987 – 1989 Mojzisovà study (see above) pointedly excluded subjects older than 30 years of age.[22] In view of the importance of this factor, Table 2 shows the rate of pregnancy by age range in the current study. Of the patients in the 31 to 45 age range, 63.6% (7/11) conceived compared with 100% (3/3) of patients in the 25 to 30 age range.

Table 2.

Pregnancies by Age Range

®The Mojzisovà study excluded women above age 30.

As age 35 is considered the “watershed” for reproductive probability, Table 3 shows the pregnancy and live birth delivery rates obtained by patients in the younger than 35 and 35+ age groups. Of the 9 patients in the < 35 group, 77.8% (7/9) conceived and 66.7% (6/9) delivered, as compared with the 60% (3/5) pregnancy and live birth delivery rates of patients in the 35+ age group.

Table 3.

Pregnancies/Deliveries by Age Group

Treatment Safety

None of the patients in the study reported any observable complications or adverse side effects as a result of their treatment. Indeed, whereas all 14 patients presented with pain at their initial evaluation, 13 of the 14 reported decreased pain during or after treatment.

Discussion

Approximately 40% of cases of female infertility are biomechanical and attributable to scarring and/or pelvic adhesions resulting from previous abdominal/pelvic surgery, endometriosis, abdominopelvic infection, inflammatory disease, postinfection tubal damage, ruptured appendix, ruptured ovarian cysts, bowel disease, or foreign body reaction. Clinically, women with known pelvic adhesions and chronic pelvic pain have responded well to this manual physical therapy.

Related Research

Although our results can be compared with those of the Mojzisovà study (1987–1989), the inclusion criteria differed markedly; ie, most of our patients were > 30 years of age, and 4 reported tubal occlusion. Women with these characteristics were specifically excluded from the Mojzisovà study. Moreover, we purposely sought to treat women with other factors known to decrease the chance of positive results, ie, hormone problems, PID, abdominal and/or pelvic surgery, and ectopic pregnancy. Nevertheless, the mean conception rate for the study group was 71.4% vs 34.3% for the group treated by the Mojzisovà method.[22]

Current and Future Research

On the basis of the encouraging results (see above), a number of future studies in facilitating natural fertility are planned. One of these, a virtual replication of the present study, will use a much larger sample of infertile women, with subjects randomized into experimental (treatment) and control (no-treatment and/or pseudo-treatment) groups.

As Pilot Study #2 suggested, this therapy seemed capable of assisting women with occluded fallopian tubes. The present study supported this finding in that 3 of the 4 patients who reported tubal occlusion had live births following therapy, including 1 woman who had been diagnosed (by laparoscopy) with total bilateral occlusion. The therapy also appears efficacious for some women who have had no success with traditional infertility treatments alone, including fertility drugs, IUI, IVF, and other assisted reproduction techniques. Separate investigations in these related areas are now being conducted.

Another area of future investigation is the long-term duration of positive effects. In Study I, 3 patients who delivered following therapy reported a subsequent pregnancy: 2 women have had a second live birth, and the third is still pregnant. In time, it might also be possible to analyze positive outcomes in relation to factors such as specific dysfunctions, pain complaints and resolution, previous miscarriages, primary and secondary infertility, duration of infertility, type and number of prior infertility therapies, prior surgeries, and the optimal number of therapy hours for individual patients.

Lastly, there are strong indications of the efficacy of this therapy as a pre-IVF adjunct, as shown in Study II.

Study II. Improving IVF Pregnancy Rates With a Manual Physical Therapy Technique

Several of our patients who had been receiving the treatment for abdominopelvic pain announced their intention to undergo IVF because they were unable (for various diagnosed causes) to achieve a natural pregnancy. Thus, in 1998, we began investigating the efficacy of site-specific soft-tissue therapy as an adjunct to ART for women with suspected or diagnosed pelvic adhesions.

Introduction

In the United States alone, the number of live birth deliveries per year resulting from all ART procedures has risen exponentially from 5600 in 1991 [25] to 14,573 in 1996, to 29,344 in 2001.[26] Of the 29,344 live birth deliveries, 21,813[27] were through the use of the woman’s own (nondonor) fresh eggs or embryos, which accounts for 75.2% of all ART procedures.[28] [Note: A live birth delivery may include multiple babies.[26]]

For those unfamiliar with the process, the typical ART cycle using fresh non-donor eggs or embryos includes 4 prepregnancy steps. The cycle starts when the woman begins taking drugs to stimulate ovulation. If successful, the next step is egg retrieval. The eggs are combined with sperm, and a few days after fertilization (if successful), selected embryo(s) are transferred into the uterus. This process is known as IVF and represents 99% of ART procedures.[27,29]

A sobering fact is that the 21,813 live births using fresh non-donor eggs represent only 27% of ART cycles started (80,864); 31.4% of egg retrievals (69,515); and 33.4% of embryo transfers (65,363).[27,30]

For ART data collection purposes, pregnancy is defined as a clinical rather than a chemical pregnancy.[31] Although a chemical pregnancy (positive pregnancy test) can be detected by a positive human chorionic gonadotropin within 5 days, a clinical pregnancy is one that has progressed to the stage where the gestational sac and fetal heart motion can be documented by ultrasound.[25,31]

Given that only 33.4% of embryo transfers result in a live birth, it is not surprising that a priori pregnancy success rates, expressed as pregnancy per cycle, retrieval, or transfer, are also disappointingly low. The 26,550 clinical pregnancies obtained by ART cycles using fresh nondonor eggs or embryos in 2001 represent 32.8% of the total ART cycles started (80,864); 38.2% of egg retrievals (69,515); and 40.6% of embryo transfers (65,363).[27,29]

Although other factors (ie, indication, number of transferred embryos) are involved, the age of the female is the primary determinant of IVF success at every stage of the ART process: the prognosis for women older than age 40 is considerably poorer than that of those who are younger.[25] For women in the 5 age groups, < 35; 35–37; 38–40; 41–42, and > 42, the calculated 2001 national rates of pregnancies per embryo transfer are, respectively: 48%; 42%; 34%; 24%; and 12%.[32] The corresponding rates for live births per transfer are: 41%; 35%; 25%; 14%; and 6%.[29, 32]

Since live births per embryo transfer have been steadily improving (from 28% in 1996 to 33.4% in 2001),[33] an intervention that increases the frequency of clinical pregnancy rates, particularly in the older age groups, would automatically increase the frequency of live-birth deliveries.

Subjects

Selection

As in Study I, the primary criteria for inclusion in this prospective study were the inability to conceive following at least 12 months of unprotected intercourse and suspected or confirmed pelvic adhesions due to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), miscarriage, or trauma within the abdominopelvic area. Other criteria were the following:

• intention to undergo IVF therapy within 15 months of the last (manual physical therapy) treatment date;
• decision to use fresh non-donor (own) embryos;
• ability to progress to the embryo transfer stage of the ART procedure (see footnote).

Between September 1998 and January 2003, a total of 36 women received an individualized series of site-specific manual physical therapy treatments. Of these, 11 patients were ultimately omitted from the present study for the following reasons: 3 used frozen nondonor eggs; 2 used donor eggs; 2 did not progress to the embryo transfer stage (1 woman conceived naturally before then); and 4 others were lost to follow-up, leaving a total of 25 patients.

Gynecologic History

All 25 patients in this study had proven or clinically well-supported suspicion of adhesions. Medical diagnoses included:

Before treatment, 14/25 patients reported a total of 21 prior natural pregnancies, only 4 of which resulted in a live birth. Twenty patients had a total of 78 prior ART attempts, including 54 IUIs. The total number of prior ART pregnancies was 3; 2 of these ended in miscarriage. Thus, before receiving the therapeutic intervention, there was only 1 prior ART full-term pregnancy in 78 attempts.

Characteristics

The 25 study participants comprised a multiethnic, primarily white, group, ranging in age from 28 to 44 years. At the time of embryo transfer, the mean age was 36 (median, 35.4), and the mean duration of infertility was 4.6 years (median, 3.5).

Procedures/Intervention

A total of 23/25 (92.0%) patients received the recommended minimum of 10 hours of treatment. [Note: As of January 2001, 10 hours was the required minimum.] None of the patients received concurrent infertility therapies during the treatment period.

Data Collection

Study patients were evaluated and treated between September 1998 and January 2003. Approximately 1 year after their last treatment date, patients were contacted to determine whether they had: (1) undergone the embryo transfer phase of IVF therapy, and (2) used fresh nondonor eggs/embryos (vs frozen or donor eggs).

The final data set includes 25 patients who underwent >/=1 IVF transfers within a maximum of 15 months following treatment, using fresh nondonor eggs/embryos. Patients who progressed from embryo transfer to pregnancy were tracked to the anticipated delivery date, when possible.

In lieu of asking patients to serve as a control group for this as yet unproven adjunctive therapy, the decision was made to compare the study results with the vast, preexisting control groups represented by the 2001 Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, released by the Centers for Disease Control and Prevention (CDC) and the American Society for Reproductive Medicine (December 2003).[26] The control group data set was extrapolated from the various figures in this report.

By law, the CDC reports its ART success rates by treatment cycles started each year, rather than per patient. In accordance with this convention, women who have started >/= 2 cycles per year are represented more than once. Eight of the 25 women in the present study had 2 cycles each, for a total of 33 cycles. CDC success rates, in all age groups using fresh nondonor eggs/embryos, are somewhat (not significantly) lower for women who underwent a previously unsuccessful ART cycle.[34]

The CDC also reports its National Summary by age groups. Although other factors (eg, infertility cause, number of embryos transferred) should be considered, a woman’s age (when using her own eggs) is the primary determinant of success at every stage of the IVF process.[25] Thus, we did not attempt to assess the effects of factors other than age in this study.

Statistical Methods

The main outcome measure—pregnancy/transfer rate (as well as the live birth/transfer rate)—was compared with the CDC 2001 rates (adjusted for age), as follows. For each attempt, the expected rate is the probability of pregnancy and live birth, respectively, for a woman of the same age in years. CDC report Figure 13 (and its accompanying text)[32] provides these data. There is no material difference in success rates between an unsuccessful first attempt and subsequent ART attempts for the same woman.[34] Because of the small sample sizes, large sample approximations for the Mantel-Haenszel statistic[35] were thought to be unreliable, and 10,000 simulations were used to obtain the 2-sided P value.

Odds ratios were estimated by the following formula, with N = Sample Size, OBS = Observed Total, and EXP = Expected Total based on the CDC 2001 data:

Estimated Odds Ratio = OBS(N-EXP)/[(N-OBS)EXP]

A 95% confidence interval for the odds ratio was obtained via 10,000 simulations, finding the odds ratios that make the P value .025 and .975.

Results

To assess the effectiveness of this site-specific manual soft-tissue therapy in improving pregnancy rates in women undergoing subsequent IVF, the main outcome measure was clinical pregnancy via the transfer of fresh embryos from nondonor eggs, within 15 months of the last (manual) treatment date.

As discussed above, this study included only those patients who had progressed beyond the early stages (egg production/retrieval and fertilization) of the ART cycle to the embryo transfer stage, and had used fresh nondonor eggs/embryos. Accordingly, the study results are compared with the 81% (n = 65,353) of the CDC cycles that reached the embryo transfer stage. These numbers were extrapolated from various figures in the 2001 report.[27,29,32,33]

As shown in Table 4, for pregnancies, based on 33 transfers, there were 22 successes. The CDC age-adjusted expected rate was 12.7 successes, and the standard error in the observed rate is 2.7 (P < .001).

Table 4.

Observed vs Expected Pregnancies

Observed = rate for Manual pre-IVF treatment (study)

Expected = projected from CDC Figure 13[32]

(Expected = Transfers times published CDC 2001 probability. For example, the published CDC 2001 pregnancy rate for a <35 year old woman is 47.7%, hence with 15 transfers, one expects 15 x 0.477 = 7.15 pregnancies; the observed number was 11.)

The estimated age-standardized pregnancy odds ratio of manual treatment pre-IVF to no pretreatment is 3.20 (95% confidence interval 1.55–8.4). As an example, if the odds of success for a control treatment are 1:2 vs the odds of success for an experimental treatment of 2:1, the odds ratio is 2.0/0.5 = 4.0. Note that equivalence corresponds to an odds ratio of 1.00, which is excluded from the pregnancy interval but not from the live birth interval (below).

The CDC pregnancy rates per age group ranged from 12% (age > 42) to 48% (age < 35). In comparison, the pre-IVF study pregnancy rates ranged from a low of 33% (age > 42) to more than 70% (age < 35).

Speaking in terms of actual patients, rather than embryo transfers, clinical pregnancies were documented in 19 of 25 women. The mean number of treatment hours was 17.1. There was no meaningful difference in treatment time between those who progressed from transfer to pregnancy (mean, 16.9 hours) and those who did not (mean, 17.5 hours).

Although the main outcome measure of this study was pregnancy within 15 months of the last (manual) treatment date, 15 of 33 transfers have resulted in live births or continuing pregnancies. As seen in Table 5, the CDC age-adjusted expected number was 10.3, and the standard error for the observed rate was 2.6 (P = .065). Similarly, it can be estimated that the age-standardized successful live birth odds ratio of manual treatment pre-IVF to no treatment is 1.86 (95% confidence interval 0.86–4.3).

Table 5.

Observed vs Expected Live Births

Observed = rate for Manual pre-IVF treatment (study)

Expected = projected from CDC National Summary, Figure 13.[29, 32]

(Expected = Transfers times published CDC 2001 probability. For example, the published CDC 2001 live birth rate for a < 35-year-old woman is 41.1%, hence with 15 transfers, one expects 15 x 0.411 = 6.16 live births; the observed number was 9.)

The confidence interval indicates that plausible outcomes range from a clinically insignificant disadvantage to a clinically important advantage for this pre-IVF treatment over common medical practice in terms of live births. Again, speaking in terms of actual patients, rather than embryo transfers, 15/25 women have already delivered (n = 13) or are still pregnant (n = 2).

Treatment Safety.

None of the patients in the study reported any observable complications or adverse side effects as a result of their treatment, and all but 1 patient who presented with pain at the initial evaluation reported decreased pain during or after treatment.

Discussion

Although we can infer that the entire confidence interval for the pregnancy odds ratio is clinically significant, the confidence interval for live births contains both clinically insignificant values (eg, near 1.0), as well as clinically significant values. However, the confidence interval for the odds ratio demonstrates the potential for anything from a slightly lower rate to a much higher rate. As can be seen in Table 4 and Table 5, the results were particularly encouraging for women > 40 years of age. Thus, further research with a larger sample is needed to define the successful live birth confidence interval more precisely.

Nevertheless, because national live births/transfer rates have been steadily improving (from 28.0% in 1996 to 33.4% in 2001),[33] an intervention that obviously increases clinical pregnancy rates should increase live birth delivery rates for patients undergoing IVF embryo transfers.

Related Research

In terms of the efficacy of alternative therapies as pre-IVF aids, there is 1 published, randomized controlled trial of the effect of acupuncture on the pregnancy rate of women undergoing IVF or intracytoplasmic sperm injection. The 160 patients (mean age, 32.5) in this German study were randomly assigned to the acupuncture or control group. The main outcome measure was clinical pregnancy. Analysis showed that the average pregnancy rate for the acupuncture group was 42.5% (34/80) vs 26.3% (21/80) for the control group (P = .03).[36] Investigators have concluded that further studies are warranted.[37,38] The acupuncture results can be compared with the average 66.7% (22/33) pregnancy rate obtained in the present study, which used the [much higher] 2001 CDC average pregnancy/transfer rate of 40.6% as the control group (P < .001). [Also see Future research, below.]

Future Research

As with Study I, the encouraging results warrant the replication of Study II, using a considerably larger sample of women (particularly in the age 35+ groups) randomized into experimental (treatment) and control (no treatment) groups. A second control group, composed of infertile women lacking strong indications of adhesion formation, would permit testing the hypothesis that this specific therapy might also benefit infertile women without adhesions, eg, by improving circulation in the pelvic region. The results of this arm of the study could be compared with acupuncture, which seems to work (in part) by increasing blood flow to the uterus.[37]

Conclusion

The data trend across the pilot and present studies seems to support the hypothesis that this distinctive protocol of site-specific manual soft-tissue therapy facilitates fertility in women with a wide array of adhesion-related biomechanical dysfunctions. The major indication for its use is a history suggesting abdominopelvic adhesions (ie, prior surgery, infection, inflammation, or trauma at the reproductive organs or neighboring structures).

This innovative, noninvasive, nonsurgical, manual therapeutic technique confers little risk and few adverse side effects or complications, and appears to be an effective treatment for facilitating natural fertility and improving pregnancy rates/embryo transfer in women undergoing subsequent IVF. Thus, it can be prescribed as an alternative or complementary treatment to standard gynecologic care and should be considered as a new adjunct to existing medical infertility treatments.*

Acknowledgments

We would like to thank Thom L. Tyler, MD, PhD, Gainesville, FL, and Michael Davidson, DC (UK), for encouraging us in this endeavor. We also thank Gerald Wiechmann, PhD (former Sr. Health Research Advisor, NIH); Cynthia Hodgson, PT, PhD; Sandra Shevlin, DP; and Kimberley Hornberger, PTA, for research, writing, and editorial assistance. Lastly, we acknowledge the crucial contributions of Amy B. Hough, our meticulous research assistant.

Note

*As this therapy was directed toward (female) mechanical infertility and would have no effect on male factor nor any anticipated effects on female medical/hormonal infertility (ie, diminished ovarian reserve, ovulatory dysfunction), the patients in this study were limited to those who reached the embryo transfer stage of the ART cycle. That is, they had progressed beyond the egg production, egg retrieval, and fertilization steps. Fresh, non-donor eggs/embryos were preferred not only by our patients but also are used in approximately 75% of all ART cycles.[28]

Footnotes

*Wurn Technique®, patent pending

Contributor Information

C. Richard King, Florida Medical and Research Institute, P.A., Gainesville, Florida.

Marvin A Heuer, College of Medicine, University of Florida, Gainesville, and Iovate Health Sciences Services, Inc., Toronto, Ontario.

Eugenia S Scharf, medical writer/researcher, Gainesville, Florida.

Jonathan J Shuster, Dept. of Statistics, College of Medicine, University of Florida, Gainesville.

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Amanda D. Rice, PhD; Kimberley Patterson, PTA; Leslie B. Wakefield, DPT; Evette D. Reed, PT; Kelseanne P. Breder, BA; Belinda F. Wurn, PT; C. Richard King III, MD; Lawrence J. Wurn, LMT

ABSTRACT

Background • Female infertility is a complex issue encompassing a wide variety of diagnoses, many of which are caused or affected by adhesions.

Objectives • The study intended to examine the rates of successful treatment of infertile women using a protocol of manual physical therapy to address underlying adhesive disease leading to infertility.

Methods • The research team designed a retrospective chart review.

Setting • The study took place in a private physical therapy clinic.

Participants • Participants were 1392 female patients who were treated at the clinic between the years of 2002 and 2011. They had varying diagnoses of infertility, including occluded fallopian tubes, hormonal dysfunction, and endometriosis, and some women were undergoing in vitro fertilization (IVF).

Intervention • All patients underwent whole-body, patient-centered treatments that used a protocol of manual physical therapy, which focused on restoring mobility and motility to structures affecting reproductive function.

Amanda D. Rice, PhD, is the director of clinical studies; KelseanneP.Breder, BA, is an intern. Both are in the research department at Clear Passage Physical Therapy in Gainesville, Florida. Kimberley Patterson, PTA, is a therapist; Leslie B. Wakefield, DPT, is a physical therapist; Evette D.Reed, PT, is a physical therapist; and Belinda F. Wurn, PT, is a clinical director. All are located in the clinical department at Clear Passage Physical Therapy. C. Richard King, III, MD, is the medical director of Clear Passage Physical Therapy.

Lawrence J. Wurn, LMT, is a therapist in the clinical department and the research director in the research department at Clear Passage Physical Therapy.

Corresponding author: Lawrence J. Wurn, LMT

OutcomeMeasures• Improvements demonstrated in the condition(s) causing infertility were measured by improvements in tubal patency and/or improved hormone levels or by pregnancy.

Results • The results included a 60.85% rate of clearing occluded fallopian tubes, with a 56.64% rate of pregnancy in those patients. Patients with endometriosis experienced a 42.81% pregnancy rate. The success rate was 49.18% for lowering elevated levels of follicle-stimulating hormone (FSH), with a 39.34% pregnancy rate in that group, and 53.57% of the women with polycystic ovarian syndrome (PCOS) achieved pregnancy. The reported pregnancy rate for patients who underwent IVF after the therapy was 56.16%. The results also suggested that the treatment was effective for patients with premature ovarian failure (POF). Conclusion • The manual physical therapy represented an effective, conservative treatment for women diagnosed as infertile due to mechanical causes, independent of the specific etiology. (AlternTherHealthMed. 2015;21(3):32-40.)

Infertility affects 6% to 11% of women in the United States,1–3 stemming from a wide variety of diagnosed medical conditions. These rates are similar to those of other developed countries.4 The most common etiologies for female infertility include occluded fallopian tubes, endometriosis, elevated levels of follicle-stimulating hormone (FSH) that signal a decrease in ovarian function, and polycystic ovarian syndrome (PCOS). Among the less common causes of infertility in women are premature ovarian failure (POF) and unexplained infertility, a classification in which no cause for infertility can be identified. To date, no single treatment has proven effective in producing natural conception in women with this broad spectrum of infertility etiologies. However, a variety of treatment options with varying degrees of invasiveness exist for each condition, from a wait-and-see approach to surgery or in vitro fertilization (IVF).

Manual manipulation therapy is used by physical therapists, osteopathic physicians, and chiropractors as a standard treatment in a wide variety of medical diagnoses, such as adhesive capsulitis, pain from postmastectomy scars, back pain, and dysfunction related to the pelvic floor.5–13 The intent of manual physical therapy is to decrease pain and increase mobility; its use is applicable to all areas of the body, from osseous structures to soft tissue, including skin and muscles.14,15 In the current 10-year retrospective analysis, a single treatment protocol, the Clear Passage Approach (CPA), demonstrated efficacy in treating female infertility that was due to a variety of etiologies. The study examined the success rates for various conditions when using the protocol, which combines several whole-body and site-specific techniques of manual physical therapy. That protocol focuses on deforming the adhesive collagen cross-links that comprise adhesions and appear to contribute to the underlying causes of infertility, including mechanical blockages and some hormonal imbalances. Decreasing adhesions that bind the organs appears to help the body to function and to respond in a more appropriate physiological manner.

METHODS

Participants

Patients treated for infertility between 2002 and 2011 at Clear Passage Physical Therapy’s (CPPT’s) sites were included in the current retrospective study. All sites included are private physical therapy practices. Infertility was defined based on criteria from the Centers for Disease Control and Prevention (CDC) as the inability to conceive for 12 months of unprotected intercourse in women younger than age 35 years or for 6 months in women older than age 35 years.2 The physicians’ diagnoses and the patients’ self-reported medical histories were examined for causes of infertility, including elevated FSH levels, blocked fallopian tubes, endometriosis, PCOS, POF, and unexplained infertility. Although most successes noted in this study were via natural conception, the study also included women who had therapy prior to IVF, by separate reference.

To be included in the study, the patients must have had a previous diagnosis of infertility prior to treatment, with a corresponding medical cause(s). Classifications of patients and the measures of success were defined for each of the 6 reported etiologies of infertility: (1) elevated FSH, (2) tubal occlusion, (3) endometriosis, (4) PCOS, (5) POF, and (6) unexplained infertility.

Elevated FSH. For the purpose of the current study, elevated FSH was defined as a level of 10 mIU/mL or higher on days 2 through 5 of the menstrual cycle. All testing for FSH levels was performed in independent, nationally regulated clinical laboratories using standardized references and protocols.16 Success was defined as a decrease in FSH levels posttreatment, as assessed at days 2 through 5 of the menstrual cycle and/or pregnancy.

Tubal Occlusion. The patients were those women with total tubal occlusion prior to treatment, including those with only 1 fallopian tube, as diagnosed by either surgery or hysterosalpingogram (HSG). In patients with bilateral tubal occlusion, treatment was considered to be successful if a posttreatment HSG demonstrated open fallopian tube(s) or if intrauterine pregnancy was confirmed, with the assumption that at least 1 tube was opened during treatment.

Endometriosis, PCOS, POF, or Unexplained Infertility. Treatment of patients with a medical history of endometriosis, PCOS, POF, or unexplained infertility was considered a success if they experienced a confirmed pregnancy.

InVitroFertilization.Patients who underwent the CPA treatment prior to IVF were considered a success if they had a positive clinical pregnancy test post-IVF, regardless of the source of implanted egg/embryos—fresh or frozen, donor or nondonor eggs.

The rates of success for patients who underwent the CPA treatment were compared with those in published studies in which the rates of success from standard medical treatments were reported for each diagnosis. All patients consented to the use of their data in a standard form for informed consent, and the study was approved by MaGil IRB (Rockville, MD, USA).

A subset of the patients included in the 10-year analysis had also been included in small, multiple case reports or reports of phase I studies; a total of 76 of the 1392 patients had been included in those previous reports 17–21.

Follow-up

Previous patients were contacted for follow-up after their treatment at CPPT using questionnaires that were sent annually by postal mail or e-mail, and they were questioned regarding pregnancies, pregnancy outcomes, and all efforts to achieve pregnancy. Patients treated for elevated FSH were asked to provide their posttreatment FSH levels. Patients lost to follow-up were not included in the analysis.

Treatment

Patients were treated using a patient-centered, individualized treatment plan of physical therapy that is standard practice at the clinic and that included a comprehensive review of the patient’s medical history and an initial evaluation. The regimen and modalities included in the treatment plan are termed the CPA, which uses a variety of recognized techniques of manual physical therapy, together with refinements and modifications of those techniques. All physical therapists had been trained and certified in the CPA; therefore, the variation in treatment was negligible between therapists. The techniques that the therapy used had been examined previously, with results published by the research group and others 15, 17–20, 22–31.

Based on each patient’s goals and subjective complaints and on findings from the initial evaluation, the CPA protocol was individualized to treat sites that presented with restricted mobility within each patient’s body. 32 The therapy used various site-specific pressures across the restrictive bands of adhered tissues and structures, working progressively deeper from the most superficial tissues, to restore mobility via myofascial release. 33 Adhesions within and between organs and interstitial spaces within the viscera were addressed using the Wurn technique 29; decreased organ motility was then addressed using visceral manipulation. 33 The amount of force and the length of time that the force was applied to each area had the potential to be significant, but the treatment was maintained within the tolerance of the patient. The standard treatment regimen was 20 hours, administered 4 hours per day for 5 days.

Statistical Analysis

Basic descriptive statistics were generated based on data from the clinic’s database. Correlations were identified using DataDesk version 6.2.1 (Data Descriptions, Ithaca, NY, USA), via a linear regression model in which items from past medical history were used as the variables against a determination of a positive or negative outcome for each measured condition. A P≤ .05 was considered suggestive, and P<.005 was considered significant. All statistical analyses were completed on the data as a whole as well as separately for variations by site or therapist; no variation was identified (data not shown).

Standard methods for odds ratio calculations were used for the CPA treatment’s success rates compared with those of published studies. 34 Significance was determined to be P≤ .05, where the odds ratio confidence interval did not include 1.0, the point of equivalence.

RESULTS

For the study, 1392 patients were identified for individual infertility conditions based on previous medical history, including physicians’ diagnoses. Each condition was analyzed separately, with patients experiencing multiple conditions being included in all analyses for which they were identified. In addition to each condition being assessed separately, the influence of age, year of treatment, treating therapist, and past medical history was analyzed for diagnoses. The number of patients and relative incidence rates for each category are shown in Table 1.

Blocked Fallopian Tubes

Blocked fallopian tubes, estimated as the primary cause of 25% to 35% of female infertility,35 were observed in 680 of the treated patients, with follow-up in 235 patients. Being the largest group treated at the clinics for infertility, several outcomes were measured. The first outcome was the success rate for the return to patency of at least 1 fallopian tube post-CPA treatment, which was a 60.85% (95% CI, 54.48-66.87). The standard-of-care option for women with blocked fallopian tubes to open their tubes is surgery, with several surgical options available depending on the location of the blockage. When the rates of patients with successfully opened fallopian tubes post-CPA treatment were compared with reported rates of success from the literature, it was observed that the CPA performed as well as or at higher rates of success than surgery did (Table 2).

Upon examining predictors for a positive outcome, previous surgery to open the fallopian tubes was a statistically significant predictor of a negative outcome with P≤ .0001. When the patients were analyzed separately based on a history of previous surgery to open their tubes, the success rate was 68.9% (124/180) for patients with no history of surgery and 34.5% (19/55) for patients whose surgical history involved attempts to open their tubes. The type of surgery performed on the fallopian tubes could not be analyzed as a predictor of outcomes due to the lack of information regarding the actual procedures performed for each patient, related either to incomplete data on or unavailability of some surgical reports. Suggestive predictors for positive outcomes (ie, open fallopian tubes post-CPA) included (1) reporting of prior physical or sexual abuse, P = .0085; (2) current neck pain, predictors of outcomes, both negative and positive. The year and treating therapist did not influence outcomes in any analysis (data not shown).

Of the patients included in the study, 428 (30.7%) exhibited multiple conditions and were represented in more than 1 categorical analysis. Although some patients were included as a success in more than 1 analysis, this finding was not viewed as a negative given the overall percentage of women included in multiple analyses, assuming that multiple diagnoses of infertility for any patient would not improve her chances of success, and that no additive effect occurred for the numbers or types of infertility.

Table 1. Overall Rates of Infertility Diagnoses and the Overall Treatment Success Rates

Abbreviations: CI, confidence interval; PCOS, polycystic ovarian syndrome; POF, premature ovarian failure; FSH, follicle-stimulating hormone; IVF, in vitro fertilization.

a) Success rate for patients with known posttreatment tubal status. b) Pregnancy rate for patients with follow-up and known tubal status of open. Decrease in FSH posttreatment.

Table 2. Success Rates for Women With Occluded Fallopian Tubes Treated With CPA as Compared With Previously Published Success Rates for Surgical Interventions

Abbreviations: CPA, clear passage approach; CPT, odds ratio; OR, odds ratio; CI, confidence interval.

P= .0124; (3) neurological conditions, P= .0312; (4) prior Again, the CPA treatment was demonstrated to have rates that sexually transmitted diseases (STDs), P= .0345; and (5) prior pelvic inflammatory disease, P= .0501. Suggestive predictors (Table 2). Patients for whom treatment did not open at least 1 for negative outcomes were (1) Crohn’s disease, P= .0380;  fallopian tube, and those who did become pregnant via IVF (2) diagnosis of pelvic adhesions, P= .0139; and (3) previous posttreatment were also included in the pre-IVF statistics. laparotomy, P = .0101.

The location and characteristics of each type of fallopian Endometriosis tube occlusion—proximal versus distal or midtubal occlusion. Endometriosis is present in approximately 11% of the and the presence of a hydrosalpinx—were analyzed to female population40 but it is the cause of infertility in 20% to 68% determine outcome predictors for successful treatment. of infertile women.41 Of the patients treated with the CPA, 558 Neither location of tubal occlusion nor presence of a had a previous diagnosis of endometriosis from a physician. Hydrosalpinx was a significant predictor of outcomes. More than one-half of those patients also presented with (P = .0429). The rate of resolution of hydrosalpinx was 44.8%; additional conditions, such as blocked fallopian tubes and 47/105 total tubes with hydrosalpinx before the CPA treatments, elevated FSH. In the endometriosis analysis, successwas were patent after therapy, with no evidence of hydrosalpinx. defined as pregnancy; the overall success rate was 42.8%—128. The rate of pregnancy for patients with successful outcomes of 299 patients with follow-up. The study included 214 patients treated, resulting in at least 1 open fallopian tube, with endometriosis as the only diagnosed condition, leading to a determination, independent of prior history of fallopian tube infertility, with follow-up on 118 patients and a pregnancy rate after surgery. The overall pregnancy rate was 56.64% (81/143), for of 37.3% (44/118). The standard medical treatments for patients who have at least 1 open fallopian tube after the CPA endometriosis are varied, depending on the goals and the treatment. One pregnancy was via IVF, with all other needs of the individual patient. Treatments may include pregnancies via natural conception. The single patient who surgical intervention to remove the endometriosis from the underwent IVF after the CPA treatment had opened her pelvic cavity, contraceptives, or combinations of these fallopian tubes experienced a subsequent natural pregnancy therapies. When compared with published success rates for following the successful IVF, suggesting that the results of the pregnancy in women with endometriosis who were treated with CPA treatment for opening blocked fallopian tubes are long-lasting, with standard medical interventions, CPA demonstrated lasting results. In fact, several women who presented bilateral tubal rates similar to or better than the standard of care (Table 3). occlusion before treatment reported multiple natural pregnancies after treatment.

Prior tubal surgery did not influence pregnancy rates in women for whom the CPA treatment was successful in opening their fallopian tubes. Pregnancy rates from patients with a known tubal status after the CPA treatment were compared with published rates of pregnancy in women who had surgical interventions for blocked tubes.

Table 3. Pregnancy Success Rates for Endometriosis Patients Treated With CPA Compared With Success Rates for Medication and Surgical Intervention Published Studies

Abbreviations: CPA, clear passage approach; OR, odds ratio; CI, confidence interval.

Endometriosis is recognized as a cause of fallopian tube occlusion, often associated with the formation of pelvic adhesions. For the 228 patients treated for both endometriosis and occluded fallopian tube(s), the current analysis found a pregnancy rate of 38.1% (45/118). For women with endometriosis and fallopian tube occlusion who had posttreatment documentation of tubal patency status, the success rate for opening blocked fallopian tubes was 59.7% (40/67). The rates of success in patients with prior surgery to open their fallopian tubes were similar to those reported in the section providing statistics on blocked fallopian tubes.

A subset of patients with endometriosis underwent the CPA treatment prior to the initiation of IVF, independent of tubal patency or other outcomes. Of the 56 patients with follow-up who underwent IVF post-CPA treatment, the clinical pregnancy rate after transfer was 55.4% (31/56), which is 1.3 times that of the national average of 40.3% for IVF transfer alone in women with endometriosis.45 This subset of patients was included in the overall statistics for IVF success.

No pregnancy was reported for either of the 2 treated patients who had both POF and endometriosis. Women with both PCOS and endometriosis had a pregnancy rate of 75% (6/8), with all pregnancies reported via natural conception. Women with endometriosis and elevated FSH had a pregnancy rate of 40% (10/25), with 2 pregnancies via IVF and 8 by natural conception. The number of women in these subcategories was not sufficient to have adequate statistical comparisons with other treatments, but do support the initiation of future studies involving these comorbid conditions. Predictors for outcomes of treatment for women with endometriosis were also performed using linear regression. Age was identified as a significant predictor (P= .001), where women younger than age 35 years were more likely to achieve pregnancy. A diagnosis of fibromyalgia was identified as a suggestive negative predictor (P = .0180).

Elevated Follicle Stimulating

Although no statistically significant predictors for outcomes were identified in the analysis, a higher pregnancy rate was observed in women younger than age 35 years than in women older than age 35 years.

PrematureOvarianFailure

POF has a 1% to 2% prevalence rate in the general population46 and is characterized by an increase in FSH and a decrease in ovarian function, with or without amenorrhea. Several studies have reported a spontaneous pregnancy rate of 4% to 10% in patients with POF, in which ovulation and normal menses occur unpredictably.47,48 Between 2002 and 2011, 9 patients with POF were treated in the research team’s clinics using the CPA, and follow-up occurred with 5 patients. One patient became pregnant, giving an overall success rate of 20%. That patient conceived naturally, with no assistive technology or ovulation-inducing medications. Because she was 30 years old, the success of the patient may have been due in part to her age, whereas the other patients were aged 38 years or older. Therefore, the length of time with elevated FSH and ovarian failure might have been less likely to affect successful treatment than for the other patients treated with POF. As so few patients were in this group, analysis for identification of predictors for outcomes could not be performed, and as no medical treatment for infertility in these patients exists, no comparisons could be performed.

Polycystic Ovarian Syndrome

PCOS affects an estimated 8% to 20% of women worldwide.49,50 Anovulation is commonly associated with PCOS patients, directly affecting fertility.49,51,52 A total of 59 patients with a history of PCOS were treated with the CPA, with follow-up available for 28 patients. The overall pregnancy success rate was 53.57% (15/28); one of the 15 pregnancies in this data subset was achieved via IVF.

Hormone

Between 2002 and 2011, 250 women were treated at the research team’s clinics for elevated FSH, as defined at a level of 10 mIU/mL or higher on days 2 through 5 of the menstrual cycle. The overall success rate for women with elevated FSH, as defined by either a decrease in FSH levels or a pregnancy, was 49.18% (60/122). The pregnancy rate was 39.34% (48/122), with 43 natural and 5 IVF pregnancies. No medical treatment that represents the standard of care currently exists for women with elevated FSH levels; therefore, no comparisons with the standard of care could be performed.

Table 4. Pregnancy Success Rates for PCOS Patients Treated With CPA Compared With Published Success Rates for Medication and Surgical Intervention Studies.

Abbreviations: CPA, clear passage approach; OR, odds ratio; CI, confidence interval.

Table 5. Pregnancy Success Rates for IVF Transfer post-CPA by Age as Compared With US National Statistics45

Abbreviations: IVF, in vitro fertilization; CPA, clear passage approach; OR, odds ratio; CI, confidence interval.

A total number of patients from 2003 to 2011, all diagnoses.

Options for standard medical treatment of PCOS include medications—clomiphene citrate, metformin, or combinations thereof—and surgical interventions to induce ovulation. The rates of pregnancy in patients treated using the CPA were directly compared with success rates for various interventions reported in the literature. The CPA demonstrated significantly higher rates of pregnancy when compared with metformin alone; the CPA treatment presented no significant differences in rates of pregnancy when compared with clomiphene citrate or the surgical interventions of ovarian wedging or drilling (Table 4).

Predictors for outcomes for PCOS patients were again analyzed by linear regression. No significant predictors were identified; however, several predictors were identified as suggestive of success, with P-values lower than .05. Suggestive negative predictors for pregnancy were (1) previous vaginal infections, P = .0254; (2) a prior STD infection, P = .0238; and (3) reported back pain, P = .0130. Suggestive positive predictors were identified as (1) dyspareunia, P = .0110, and (2) dysmenorrhea, P = .0075. Although not significant in the analysis, patients with prior surgery to correct anovulation—ovarian wedging or drilling—did not report overall improvement levels that were similar to those of patients who had not undergone prior surgery for PCOS, suggesting further studies involving this patient population should be examined.

Unexplained Infertility

Unexplained infertility affects an estimated 18% to 28% of women, with no medical cause for the inability to conceive.57,58 For the 10 years presented in this report, 20 women were treated at the clinic with unexplained infertility, with follow-up with 12 of these patients. These patients experienced a 25% pregnancy rate (3/12). One of the 3 pregnancies was attributed to IVF, whereas the other 2 were via natural conception. These rates are in line with published observational rates of pregnancy in a population with unexplained infertility59; however, the CPA may decrease the time to first conception in these patients, and this finding presents a topic for future investigation.

Treatment Prior to IVF

In 2010, more than 135 800 IVF cycles were completed in the United States. The national average for pregnancy after transfer was 37.3% in 2010, as reported by the Society for Assisted Reproductive Technology (SART),45, with a distinct decrease in pregnancy rates by 5-fold for the older-than-age-42 category versus the younger-than-age-35 category.

A total of 231 women were treated with the CPA prior to undergoing IVF. The overall pregnancy rate for the 146 patients with follow-up was 56.16% (82/146), which is 1.5 times that of the national IVF pregnancy rate without the CPA.45 Those data encompassed all infertility diagnoses, including those noted by the research team’s group, allowing for a direct comparison to SART’s overall data. A clear trend and an associated predictor for outcomes by age existed, in which younger patients had higher rates of pregnancy with subsequent IVF cycles. Table 5 shows the comparisons for success rates for women treated with the CPA prior to IVF transfer compared with the national statistics for all transfers by age between 2003 and 2011. The data demonstrate significantly higher rates of success in patients treated with the CPA prior to IVF transfer for all ages.

The only suggestive positive predictor for outcomes for the IVF data set as a whole was age (P = .0443). This observation is in line with standard guidance for infertility and current literature in which the younger-than-age-35 category has demonstrated higher pregnancy rates.

DISCUSSION

Physical therapy is a commonly used medical adjuvant treatment for a variety of conditions. It is typically focused on one area of the body, with a limited number of modalities. In this article, the research team has demonstrated successful treatment with the CPA of women with various underlying causes for infertility. The CPA uses a combination of manual physical therapy techniques to treat the entire body of each patient, with a focus on decreasing adhesions and cross-links that bind neighboring tissues during a prior healing event. The CPA treatment appeared to improve or restore function.

Figure 1. Hypothesized mechanism for the positive effect of the cpa treatment on the female reproductive system. In the figure, the force (1) that is applied to the restricted area of the ovary frees the tissue. The result (2) is excitation of the visceral (organ) effector, which sends an impulse to the integration center of the central nervous system (CNS) via the afferent neuron, while it simultaneously increases blood and lymphatic flow to the local tissue. This excitation causes an efferent impulse and a release of acetylcholine (ACH), which excites the ovary (3) to release progesterone and estrogens. This release triggers an increase in the endometrial lining of the uterus (4a). Simultaneously, progesterone and estrogens provide negative feedback to the hypothalamus/pituitary (4b) for the production of follicle-stimulating hormone (FSH). The response of the ovary to normal levels of circulating FSH (5) and the development of the dominant follicle trigger release of luteinizing hormone (LH), which initiates the release of lymphocytes from the spleen to facilitate follicular development and oocyte release (6). The vasodilatation and ability of the tissues to function normally promote the ability of the lymphocytes to exit the blood vessels and enter the ovarian tissues.

Abbreviation: CPA, clear passage approach.

For patients with various infertility diagnoses, with a return of fertility and fecundity.

The hypothesized mode of action for the CPA has been developed based on documentation in the literature, clinical observations, and knowledge of mechanisms and modes of action from other manual therapy modalities (Figure 1). The CPA, with an emphasis on the Wurn technique for patients in the current study, appeared to work by deforming adhesions in the body, thereby allowing increased mobility, motility, and function of the structures involved in fertility.

Some causes of infertility are straightforward, such as occluded fallopian tubes, whereas others are quite complex, such as POF and PCOS. In cases of straightforward adhesive disease, dissociation and deformation of the adhesions are sufficient in many cases to restore fertility. However, in more complex etiologies of infertility, including hormonal regulation, the research team’s hypothesis is that the therapy affects 1 or more mechanical blocks in communication between the brain and the reproductive system—the hypothalamic-pituitary-gonadal axis or other mechanical paths. The research team theorizes that these blocks may be caused either by (1) misalignment of the cranium or spine, affecting nervous system communication; (2) dysfunctional tissues surrounding blood vessels; (3) nerves in the pelvic region decreasing efficient stimulation, or (4) a combination of any of these causes. Aberrant ovulation and hormonal function have been observed in women with spinal injuries, supporting the observation that mild spinal misalignment could be sufficient to influence hormonal function. 60

Treatment with the CPA had a 60.85% success rate overall for opening 1 or both tubes in women with total tubal occlusion, and the data suggest that the fallopian tubes remained open, indicating that the adhesions did not return unless subsequent inflammation, infection, trauma, or surgery occurred. Prior surgery to treat occluded fallopian tubes was identified as a negative predictor for the success of the CPA treatment. This finding is hypothesized to be due to the damage to the fallopian tubes that occurs during surgical procedures, which has been suggested to be the initiating factor for tubal reocclusion in surgical literature.61,62 The rates of success for the CPA, when directly compared with the rates of success for surgical interventions, demonstrated equivalence or superiority for tubal patency postintervention and for subsequent pregnancy. Further studies to assess the impact of the type of surgical procedure and outcomes prior to the CPA treatment are planned.

The use of the CPA in treating women with endometriosis had previously been shown by the research group to be efficacious in the treatment of sexual dysfunction, dyspareunia, and dysmenorrhea, with long-lasting results.18,19,63 The success in using the CPA as a treatment for women experiencing infertility associated with endometriosis has now been demonstrated, with a 42.8% pregnancy rate and equivalence to pregnancy rates after surgical interventions. Given the high rate of success, further studies are warranted to assess the effect of the stage of endometriosis on treatment outcomes.

Hormonal dysregulation impacts a woman’s fertility and is often challenging to treat. The CPA has been shown in the current study to affect hormonal regulation positively in women with POF, PCOS, and elevated FSH, with success rates of 20%, 53.6%, and 49.2%, respectively. The number of patients in the POF studies was not adequate to perform stringent analyses; however, further studies are planned, given the positive initial results observed. The rate of pregnancy in PCOS patients treated with the CPA, when directly compared with surgical or medication interventions, was again demonstrated to be equivalent or superior to those standard interventions.

The CPA treatment was also demonstrated to be beneficial to those patients who underwent IVF after treatment, with pregnancy rates 1.5 times higher than those for IVF alone, as reported by SART.45 When compared with national statistics for IVF success rates, the CPA was shown to be superior to IVF alone for all age categories.

Limitations of this study include a high rate of drop-out to follow-up and a dependence on a comprehensive medical history upon the patients’ self-reports of that history and on their provision of the surgical and test results. In addition, incomplete data existed on male factors affecting fertility rates in the treated women. Consequently, the actual rates of success for female infertility may be higher than reported here because it is estimated that up to 40% of infertile couples have male factors that contribute to infertility.64,65 Live birth rates were unable to be reported due to low follow-up rates. Additional prospective, controlled studies are planned to examine further the suggestive predictors and comprehensive data for outcomes post-CPA treatment for all etiologies of infertility.

CONCLUSIONS

Manual physical therapy has been demonstrated to reverse female infertility attributed to occluded fallopian tubes, hormonal dysregulation, endometriosis, and unexplained infertility and to increase the success of in vitro cycles.

AUTHOR DISCLOSURE STATEMENT

The research team received no funding for this study and has no conflicts of interest related to it.

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