OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

NCT05230277 | Unknown DMC

• 1 other identifier: TREAT OF IBS SYMPTOMS IN ADULT
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

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.

Conditions

OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  3 months

Study Arms (2)

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

PLACEBO COMPARATOR

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

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

EXPERIMENTAL

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)

Interventions

the active osteopathic treatment (AOT) 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.

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

the sham osteopathic treatment 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 sham osteopathic treatment (SOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Troyes: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 8, 2022
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-03