Irritable Bowel Syndrome and Osteopathic Manipulative Therapy

NCT02932111 | Terminated DMC

• 1 other identifier: P150920
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel dysfunction during recurrent periods of shorter or longer duration. The absence of well-defined pathophysiological marker requires a clinical definition. The most used are the Rome criteria III whose version was published in 2006 and version IV under development. An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people, found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in the total population; the results of this study were comparable to data obtained in the USA. A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these studies, there is a very large predominance of women (sex ratio near 2), with a preponderance of subjects of the age group 40-50 years. IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs generated by associated diseases: number of visits to the general practitioner, to the specialist, the prescription and realization of complementary examinations, hospitalization, purchase drugs and work stoppage. From a pathophysiologic perspective, IBS is now considered as a multifactorial disease involving varying degrees, depending on the individual variables, visceral hypersensitivity, disturbances of digestive motility, impaired sensorimotor way communications between the gastrointestinal tract and the central nervous system, intestinal micro-inflammation. Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve the symptomatology of IBS in patients with functional gastrointestinal disorders.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Osteopathic manipulative treatment; pain

Outcome Measures

Primary Outcomes (1)

• Changes from baseline of IBSSS at V4.

  It measured by the IBS severity score (IBSSS) after osteopathic manipulative treatment. The IBS Severity Scoring System is a validated measure to assess the severity of IBS symptoms, and can help monitor response to treatment.

  8 weeks after the first osteopathic manipulative treatment

Secondary Outcomes (8)

• Clinical improvement (IBSSS)

  3 and 6 months after the first osteopathic manipulative treatment

• Percentage of patients with improvement at V4, V5 and V6.

  2, 3 and 6 months after the first osteopathic manipulative treatment

• Cardinal signs of IBS measured by visual analogic scales

  2, 3 and 6 months after the first osteopathic manipulative treatment

• Shape of the stool

  2, 3 and 6 months after the first osteopathic manipulative treatment

• Changes of the severity of IBS

  2, 3 and 6 months after the first osteopathic manipulative treatment

Study Arms (2)

Osteopathic session

EXPERIMENTAL

The osteopath put fingers on abdominal projection of the junction and sinks deeply into the abdomen until it perceives the trigger zone. Once in contact with the sphincter, it performs friction in the hourly sense, vibration, inhibitions or rebounds.

Procedure: osteopathic session

Placebo manipulative session

PLACEBO COMPARATOR

The Osteopath will touch the patient's limbs at the same place of osteopathic manipulative treatment, but without any intention of treatment and without any known and indexed reproduction techniques to simulate an osteopathic treatment, without its benefits.

Procedure: Placebo manipulative session

Interventions

osteopathic session PROCEDURE

3 osteopathic manipulative sessions. An six-week double-blind treatment period lasting from week 2 (Visit V1) until week 6, Visit 3.

Osteopathic session

Placebo manipulative session PROCEDURE

3 osteopathic manipulative sessions. An six-week double-blind treatment period lasting from week 2 (Visit V1) until week 6, Visit 3.

Placebo manipulative session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes ≥18 years.
• Patient suffering from IBS according to the Rome III criteria:
• Physical examination without clinically relevant abnormalities during the Screening period.
• Patient is willing to be compliant with study procedures.
• Patient who signed the informed consent before carrying out any procedure related to the study.
• Mentally competent, able to give written informed consent prior to any study-related procedure and compliant to undergo all visits and procedures scheduled in the study
• Medical Insurance

You may not qualify if:

• Patient has had surgery that meets any of the following criteria:
• Patient has any elective major surgery planned or expected at any time during the study.
• Use of new drugs indicated in treatment the IBS
• Patient has a history of inflammatory bowel diseases, complicated diverticulosis (i.e. diverticulitis), ischaemic colitis, microscopic colitis.
• Patient has a history of organic abnormalities of the GI tract, intestinal: obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aorto-iliac disease).
• Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
• Patient has an active biliary duct disease or a history of Sphincter of Oddi dysfunction.
• Patient has a history of gluten enteropathy.
• Patient has a history of lactose intolerance as assessed by response to diet.
• Patient has a small intestinal bacterial overgrowth.
• Patient has a current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
• Patient has a history of ectopic endometriosis.
• Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
• Patient has a history of human immunodeficiency virus infection.
• Patient has insulin-dependent diabetes mellitus.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Avicenne Hospital

Bobigny, France

Location

Related Publications (5)

• Hundscheid HW, Pepels MJ, Engels LG, Loffeld RJ. Treatment of irritable bowel syndrome with osteopathy: results of a randomized controlled pilot study. J Gastroenterol Hepatol. 2007 Sep;22(9):1394-8. doi: 10.1111/j.1440-1746.2006.04741.x.

  PMID: 17716344 BACKGROUND

• Florance BM, Frin G, Dainese R, Nebot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hebuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):944-9. doi: 10.1097/MEG.0b013e3283543eb7.

  PMID: 22546751 BACKGROUND

• Attali TV, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013 Dec;14(12):654-61. doi: 10.1111/1751-2980.12098.

  PMID: 23981319 BACKGROUND

• Muller A, Franke H, Resch KL, Fryer G. Effectiveness of osteopathic manipulative therapy for managing symptoms of irritable bowel syndrome: a systematic review. J Am Osteopath Assoc. 2014 Jun;114(6):470-9. doi: 10.7556/jaoa.2014.098.

  PMID: 24917634 BACKGROUND

• Piche T, Pishvaie D, Tirouvaziam D, Filippi J, Dainese R, Tonohouhan M, DeGalleani L, Nebot-Vivinus MH, Payrouse JL, Hebuterne X. Osteopathy decreases the severity of IBS-like symptoms associated with Crohn's disease in patients in remission. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1392-8. doi: 10.1097/MEG.0000000000000219.

  PMID: 25357218 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Bouchoucha, MD

  Hospital Avicenne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 13, 2016
• Study Start: May 12, 2017
• Primary Completion: March 12, 2023
• Study Completion: July 12, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)