NCT02343237

Osteopathic Medicine in Fibromyalgia Syndrome

A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.

Detailed description

An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia. This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension. This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months. The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA). The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations. This study will also allow to identify the profile of the osteopathic treatment responders patients

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
PROCEDURE	Osteopathic treatment	osteopathic sessions of 20 minutes
PROCEDURE	Factitious osteopathic treatment	6 factitious osteopathic sessions of 20 minutes

Timeline

• Start date: 2015-12-02
• Primary completion: 2017-07-20
• Completion: 2018-07-27
• First posted: 2015-01-21
• Last updated: 2025-09-05

Locations

1 site across 1 country: France