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The study encountered difficulties in including patients
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Type : interventional, randomized single blind study Aim : to evaluate 3 sessions of osteopathy on IBS-like symptoms associated with ulcerative colitis in remission Number of patients : 50 (randomization 1:1) Duration of the inclusion period : 2 years Primary end-point : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months
Osteopathy has been shown to be effective in IBS patients in few studies and to improve 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Active Comparator | The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. |
|
| Untreated group | Sham Comparator | The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathy | Other | testing osteopathy Vs Treating osteopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the score change of Irritable Bowel Syndrome Severity Scoring System (IBS SSS) | index of severity of Irritable Bowel Syndrome symptoms | Month 1, Month 2, Month 3, Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| IBDQol : Inflammatory Bowel Disease Questionnaire | Index of quality of life dedicated to Inflammatory Disease Bowel patients : the score is high, better the quality of life | Month 1, Month 2, Month 3, Month 4 |
| FACIT-F : Functional Assessment of Chronic Illness Therapy-Fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryan Cavicchi, MD, PhD | Clinique Paris-Bercy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Paris Bercy | Charenton-le-Pont | 94220 | France |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D055360 | Osteopathic Physicians |
| ID | Term |
|---|---|
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Validated fatigue score with question about quality of life 45/5000 if the score is high, the patient is tired |
| Month 1, Month 2, Month 3, Month 4 |
| Evaluation of osteopathic dysfunctions | 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. | Month 1, Month 2, Month 3, Month 4 |
| Questionnaire for use of medication for Irritable Bowel Syndrome | if treatment modification, dose reduction or change in treatment | Month 1, Month 2, Month 3, Month 4 |
| D004066 | Digestive System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D015212 | Inflammatory Bowel Diseases |