OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Centre Hospitalier de Troyes

Status: Not yet enrolling

Conditions: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Treatments: Other: the active osteopathic treatment (AOT); Other: the sham osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05230277

TREAT OF IBS SYMPTOMS IN ADULT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 404 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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404 participants in 2 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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

Treatment:

Other: the sham osteopathic treatment

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

Experimental group

Description:

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.

Treatment:

Other: the active osteopathic treatment (AOT)