OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

NCT ID: NCT05230277

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The experimental group is defined by the sham osteopathic treatment (SOT)

Patients will receive 3 SOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the SOT. The positions of the patient and the practitioner will be the same as in the AOT group

Group Type: PLACEBO_COMPARATOR

the sham osteopathic treatment

Intervention Type: OTHER

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

The experimental group is defined by the active osteopathic treatment (AOT)

Patients will receive 3 AOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the AOT.

Group Type: EXPERIMENTAL

the active osteopathic treatment (AOT)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female patients ≥ 18 ans
• IBS patients (defined according to the Rome IV Criteria)
• Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
• Negative colonoscopy within the last 5 years.
• Psychologically fit to provide signed informed consent.
• Agreed to undergo the procedures associated with the study
• Medical insurance

Exclusion Criteria

• Have not received any osteopathic treatment in the last 12 months
• Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
• Pregnancy
• Planned or expected elective surgery during the study
• Dietary and lifestyle changes in the previous month.
• Use of prohibited concomitant medications in the previous month.
• Inability to understand or cooperate during the study.
• No current participation in a biomedical research trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier de Troyes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TREAT OF IBS SYMPTOMS IN ADULT

Identifier Type: -

Identifier Source: org_study_id