Prospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2018; 24(19): 2108-2119
Published online May 21, 2018. doi: 10.3748/wjg.v24.i19.2108
Decreasing recurrent bowel obstructions, improving quality of life with physiotherapy: Controlled study
Amanda D Rice, Kimberley Patterson, Evette D Reed, Belinda F Wurn, Kristen Robles, Bernhard Klingenberg, Leonard B Weinstock, Janey SA Pratt, C Richard King, Lawrence J Wurn
Amanda D Rice, Department of Internal Medicine, College of Medicine-Phoenix, University of Arizona, Phoenix, AZ 85004, United States
Kimberley Patterson, Evette D Reed, Belinda F Wurn, Kristen Robles, Lawrence J Wurn, Clear Passage Therapies, Gainesville, FL 32606, United States
Bernhard Klingenberg, Department of Mathematics and Statistics, Williams College, Williamstown, MA 01267, United States
Leonard B Weinstock, Clinical Medicine and Surgery, Washington University School of Medicine, Specialists in Gastroenterology, LLC, St. Louis, MO 63141, United States
Janey SA Pratt, Department of Surgery, Stanford University School of Medicine, Palo Alto, CA 94035, United States
C Richard King, College of Medicine, University of Florida, Gainesville, FL 32607, United States
Author contributions: Rice AD, Klingenberg B, King CR and Wurn LJ designed the study; Patterson K, Reed ED, Wurn BF and Wurn LJ performed the treatment; Rice AD performed subject follow up and control subject data collection; Klingenberg B performed the statistical analysis; Rice AD wrote the manuscript; Patterson K, Reed ED, Wurn BF, Robles K, Klingenberg B, Weinstock LB, Pratt JS, King CR and Wurn LJ revised the manuscript for final submission.
Institutional review board statement: This study was approved by MaGil Institutional Review Board.
Clinical trial registration: registration #NCT02639195
Informed consent statement: All subjects provided consent for the study. Treated subjects provided written consent; untreated subjects provided consent via the Assessment Center online system.
Conflict-of-interest statement: Belinda F Wurn and Lawrence J Wurn are the owners of Clear Passage. All other authors report no conflicts.
Data sharing statement: Data will be available upon request deidentified with IRB approval.
CONSORT 2010 statement: The guidelines of the CONSORT 2010 Statement have been adopted for this study.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Lawrence J Wurn, Research Associate, Clear Passage Therapies, 4421 NW 39th Ave, Suite 2-2, Gainesville, FL 32606, United States.
Telephone: +1-352-3361433 Fax: +1-352-3369980
Received: February 26, 2018
Peer-review started: February 27, 2018
First decision: March 15, 2018
Revised: April 22, 2018
Accepted: May 6, 2018
Article in press: May 6, 2018
Published online: May 21, 2018
Research background

Manual physiotherapy (mPT), called “manual physical therapy” in the United States, has been used to treat a wide variety of adhesive conditions including burns, adhesive capsulitis, radiculopathy, pain and the lessening of scars. In pilot studies, independent radiologic reports showed that the Clear Passage Approach (CPA), a specialized mPT performed in an outpatient setting, cleared bowel stricture and obstruction, obviating the need for planned surgical adhesiolysis and bowel resection. In case control and efficacy studies, CPA demonstrated effectiveness decreasing adhesions and pain, and improving quality of life (QOL) in subjects with recurrent small bowel obstruction (SBO).

Surgery is often cited as a primary cause of recurrent SBO due to the formation of post-operative adhesions. If a non-invasive outpatient therapy can decrease recurrent SBO and reduce the need for additional surgeries, it can improve quality of life for patients, with lower risk and decreased cost.

Research motivation

Adhesions that form after surgery present major problems for physicians and their patients. Surgeons note that adhesion barriers and gels are not always effective at preventing recurrent adhesions. The opportunity to delay or prevent post-surgical adhesions that can cause pain and recurring bowel obstruction is profound for patients. Many people live in fear that another major surgery or death could occur at any time, due to a recurrent obstruction.

Research objectives

The study has two main objectives: (1) To determine whether a manual physiotherapy can lower the rate of repeat SBO in patients who have undergone prior adhesive bowel obstructions and surgeries; and (2) to examine whether the therapy can improve the quality of life of these patients, using a validated test.

Research methods

This is a controlled phase two study in which 103 subjects with a history of recurrent adhesive SBO were treated with a manual physical therapy called the CPA. The focus of the therapy was to decrease adhesive crosslinking in abdominopelvic viscera. Pre- and post-therapy data measured recurring obstructions and quality of life using a validated test sent 90 d after therapy. Results were compared to 136 untreated control subjects who underwent the same measurements, but who did not receive any therapy. Until this method was developed, physical therapy has never been investigated as a course to treat recurring SBO.

Research results

Despite histories of more prior hospitalizations, obstructions, surgeries, and years impacted by bowel issues, the 103 CPA-treated subjects reported a significantly lower rate of repeat SBO than 136 untreated controls (total obstructions P = 0.0003; partial obstructions P = 0.0076). Subjects treated with the therapy demonstrated significant improvements in five of six total domains in the validated Small Bowel Obstruction Questionnaire (SBO-Q). Domains of diet, pain, gastrointestinal (GI) symptoms, quality of life (QOL) and pain severity when compared to post CPA treatment were significantly improved (P < 0.0001). The medication domain was not changed in the CPA treated group (P = 0.176).

Numerous studies examine the use of mPT to decrease adhesions and pain, and to improve function for conditions in various parts of the body. Pilot studies that examine the use of CPA include independent radiographs of cleared bowel obstruction. In a 10-year retrospective study of using CPA to treat adhesion-related female infertility (n = 1392), CPA opened blocked fallopian tubes in 60.85% (143/235) of women diagnosed with total tubal occlusion. In a recent study, mPT was shown to disrupt bowel adhesions in a rat model. This is the first controlled study of using a manual physiotherapy to decrease adhesions in the bowel.

The availability of the therapy is presently limited to private outpatient clinics in the United States and United Kingdom where therapists have been fully trained and certified in the CPA.

Research conclusions

A manual physiotherapy significantly improved quality of life and significantly decreased the rate of re-occlusion for patients with a history of SBO. Performed in an outpatient setting, the non-invasive therapy significantly reduced repeat obstructions. In addition, the physical therapy has a much lower risk and cost than hospitalization or surgery.

The study proposes that manual physiotherapy, which is commonly used to decrease adhesions in a variety of conditions, may be useful to decrease adhesions in the bowel. As such, it may delay or prevent recurring SBO.

This study noted that: (1) Post-surgical adhesions are frequently cited as the primary cause of SBO; (2) average costs in the United States for adhesiolysis and SBO are $65955 and $114175, respectively; (3) average hospital stays for adhesiolysis and SBO are 8.4 d and 14.2 d, respectively; (4) costs for a novel non-surgical physiotherapy to address adhesions and SBO are less than $7000; (5) Subjects treated with the therapy reported a significantly lower rate of repeat SBO than the untreated controls (total obstructions P = 0.0003; partial obstructions P = 0.0076); (6) subjects treated with the therapy demonstrated significant improvements in five of six total domains in the validated SBO-Q; (7) statistical analysis showed a significant increase in all six measures of trunk range of motion (flexion, extension, left and right side bending, left and right rotation.)

A manual physiotherapy significantly decreased the rate of recurrent small bowel obstruction (SBO) and improved quality of life for patients with a history of prior SBO. Based on the decreased number of recurring obstructions and the measurable improvements in trunk range of motion, this manual physiotherapy can significantly improve outcomes and quality of life for patients who undergo abdominal or pelvic surgery to treat adhesions or SBO.

This study proposes the use of a specialized manual physiotherapy, the CPA, to delay or prevent recurring SBO. This study confirmed and quantified hypotheses from earlier pilot studies that CPA could increase QOL, delay or prevent recurring SBO, and delay or obviate the need for additional surgery for patients with recurring SBO, with less risk and a lower cost than the present model. The major implication for clinical practice is that physicians, who are often stymied by the frequent recurrence of adhesions and SBO following abdominal surgery or resection, now have a less risky and less costly alternative to repeat surgery.

Research perspectives

There is a place for a multi-disciplinary approach to a vexing problem for surgeons - the recurrence of adhesions and SBO following abdominal surgery or pelvic surgery. We hope to be able to quantify further the degree to which CPA can decrease the recurrence of SBO, and the need for repeat surgeries. A prospective controlled study with closely matched study groups could be performed with the CPA method vs sham physiotherapy.