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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS
• Intervention / Treatment: Other: the sham osteopathic treatment; Other: the active osteopathic treatment (AOT)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 404
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	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
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness (response to treatment) at 1-month follow-up:	It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness at 3 months (response to treatment based on the IBS-SSS) and changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 months.	It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment. Changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 monthsThe IBS-QOL is a self-report measure of quality of life specific to irritable bowel syndrome (IBS) often used to assess the impact of IBS and its treatment.	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Troyes
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TREAT OF IBS SYMPTOMS IN ADULT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No