Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission (OSTEOMIC)
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|ClinicalTrials.gov Identifier: NCT04159311|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Ulcerative Colitis||Other: Osteopathy||Not Applicable|
Osteopathy has been shown to be effective in IBS patients in few studies and to improse IBS-like symptoms in a short series of Crohn patients. IBS-like symptoms are frequent in patients with ulcerative colitis in remission (about 20 %).
The aim of this interventional, randomized single blind study is to evaluate the impact of 3 sessions of osteopathy on Irritable Bowel Syndrome symptoms in 50 patients (randomisation 1:1) with ulcerative colitis in remission (defined by fecal calprotectin < 200 µg/g).
The two group of patients will have 4 sessions of osteopathy (M0, M1, M2, M3). The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
Primary end-points : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months (M3) Secondary end-points : Inflammatory Bowel Disease Questionnaire ol, Functional Assessment of Chronic Illness Therapy-Fatigue at M3, evaluation of osteopathic dysfunctions between M0 and M3, questionnaire for use of medication for IBS between M0 and M3
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Osteopathy on IBS-like Symptoms Associated With Ulcerative Colitis in Patients in Remission|
|Actual Study Start Date :||November 14, 2019|
|Estimated Primary Completion Date :||November 2, 2021|
|Estimated Study Completion Date :||November 2, 2021|
Active Comparator: Treated group
The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3.
testing osteopathy Vs Treating osteopathy
Sham Comparator: Untreated group
The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).
testing osteopathy Vs Treating osteopathy
- Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS) [ Time Frame: Month 1, Month 2, Month 3, Month 4 ]index of severity of Irritable Bowel Syndrome symptoms
- IBDQol : Inflammatory Bowel Disease Questionnaire [ Time Frame: Month 1, Month 2, Month 3, Month 4 ]Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life
- FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: Month 1, Month 2, Month 3, Month 4 ]
Validated fatigue score with question about quality of life 45/5000
if the score is high, the patient is tired
- Evaluation of osteopathic dysfunctions [ Time Frame: Month 1, Month 2, Month 3, Month 4 ]
it will be interesting to see if patients with remission-prone RCH have similar osteopathic dysfunctions at the beginning of the study, and then if the management during the study influences or not these osteopathic dysfunctions.
Osteopathic dysfunction is an alteration of the mobility, viscoelasticity or texture of somatic system components. It is accompanied or not by a painful sensibility.
- Questionnaire for use of medication for Irritable Bowel Syndrome [ Time Frame: Month 1, Month 2, Month 3, Month 4 ]if treatment modification, dose reduction or change in treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159311
|Contact: Bouchra Benkessou, SC||0033 email@example.com|
|Contact: Maryan Cavicchi, MD, PhD||0033 firstname.lastname@example.org|
|Study Director:||Maryan Cavicchi, MD, PhD||Clinique Paris-Bercy|