NCT05230277

OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Centre Hospitalier de Troyes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Osteopathy is chosen by patients as a treatment for IBS but the 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.

Detailed description

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: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: 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: 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: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 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).

Conditions

• OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Interventions

Type	Name	Description
OTHER	the active osteopathic treatment (AOT)	The AOT will first consist of the application of a visceral technique. The patient will lie on their stomach and the osteopath will touch the patient's abdomen with a wide two-handed grip. The action will consist of following the abdominal tissues in directions where tissue mobility is allowed and occurs without restriction, from the surface to the depth of the abdomen. A change in the elasticity of the colon will then be perceived when the mobility restrictions of the tissues are dissipated. The osteopath will then use a technique on the sacrum according toik-g the procedure described by Attali et al. \[8\] which consists in mobilizing the sacrum between the iliac bones.
OTHER	the sham osteopathic treatment	For SOT, the patient will lie on their stomach and the osteopath will use a wide two-handed grip on the patient's abdomen to deliberately mobilize it in an imprecise manner. Next, a technique with no apparent therapeutic effects, the light touch, first described by Licciardone et al. \[13\] and proposed by others to perform simulated bone manipulations \[14\], will be applied to the sacrum

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-02-08
• Last updated: 2023-03-02