Osteopathy in the treatment of irritable bowel syndrome symptoms in adults: study protocol for a randomized controlled trial
Keywords:Osteopathy, Sham therapy, IBS symptoms, Randomized controlled trial
Background: Osteopathy is chosen by patients as a treatment for irritable bowel syndrome (IBS) but evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.
Methods: Design: a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group included active osteopathic treatment. Control group included sham osteopathic treatment. Randomization was in allocation ratio 1:1. Assessment time was carried as inclusion and baseline assessment (day-1; initial visit V0), day 8, day 15 and follow-up (1 month and 3 months), treatments (day 0, day 8, day 15). Primary endpoint was effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint was effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size was 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).
Conclusions: The two-group parallel, randomized, double-blind, placebo-controlled trial (sham therapy) in which the expectations and experiences of patients in the control group are comparable to the experimental group is the most accurate design for demonstrating the effectiveness of osteopathy on IBS symptoms. Future studies could use such a design to assert causality.
Trial registration: The trial has been registered in clinicalTrials.gov. Registration number: NCT05230277; registered on 7 February 2022.
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