Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial

"Participants allocated to the osteopathic care group will receive 4 weekly consultations of person-centered osteopathic care. Each consultation will last approximately 45 minutes and consist of a careful medical history, a clinical examination, treatment, and advice (e.g. exercise, dietary, lifestyle).~The osteopathic treatment protocol could be labeled as 'custom tailored': the determination of the treatment was left to the clinical judgment of the osteopath, meaning that no predefined, standardized osteopathic protocol would be implemented. Standard osteopathic techniques (Glossary of Osteopathic Terminology) can be applied, including diagnostic techniques (e.g. observation, neurological tests, palpation, and motion testing) and therapeutic direct (e.g. high-velocity low-amplitude, muscle energy), indirect techniques (e.g. strain counter strain, balanced ligamentous tension, balanced membranous tension), or combined techniques."

"For this trial, sham intervention will mimic the osteopathic care according to the touch equality assumption. Therefore, it mimics a clinical examination and treatment. The sham clinical evaluation involves a full evaluation of the position and mobility of the spine.This screening of the patient will be performed using conventional osteopathic manual tests, without any intention to make a diagnosis. Sham treatment will involve light manual contact, with the subject lying supine on the treatment table."

"In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified FODMAP-gentle approach involves a targeted, less restrictive elimination of selected high-FODMAP foods."