Osteopathic Medicine in Fibromyalgia Syndrome (FIBROPATHIC)

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

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Procedure: Osteopathic treatment; Procedure: Factitious osteopathic treatment

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

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75004
      • Hotel-Dieu Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patient Male or female aged at least of 18
2. Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
3. Patient suffering from fibromyalgia for over a year
4. Patient with stable medical/non medical treatment for at least 1 month before the recruitment
5. Patient referred to a medical center for a multidisciplinary approach
6. Patient who can be followed for at least 12 months after the end of the osteopathic sessions
7. Patient giving his informed consent to participate in the study
8. Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

1. Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
2. Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
3. Severe psychiatric pathology : major depression, psychosis
4. Pregnancy or breast feeding
5. The patient is already included in another clinical study
6. Patient under judicial protection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathy +; 75 patients will make 6 osteopathic sessions	Procedure: Osteopathic treatment; osteopathic sessions of 20 minutes
Active Comparator: Osteopathy -; 75 patients will make 6 factitious osteopathic sessions	Procedure: Factitious osteopathic treatment; 6 factitious osteopathic sessions of 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain during the 6 weeks of osteopathic treatment	The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)	6 weeks after osteopathic treatment
Quality of life	Questionnaires: FIQ and SF-36	3 months after osteopathic treatment
Quality of life	Questionnaires: FIQ and SF-36	6 months after osteopathic treatment
Quality of life	Questionnaires: FIQ and SF-36	1 year after osteopathic treatment
Fatigue	Questionnaires: multidimensional fatigue inventory (MFI) scale	6 weeks after osteopathic treatment
Fatigue	Questionnaires: MFI scale	3 months after osteopathic treatment
Fatigue	Questionnaires: MFI scale	6 months after osteopathic treatment
Fatigue	Questionnaires: MFI scale	1 year after osteopathic treatment
Pain	Questionnaires: Brief Pain Inventory (BPI)	6 weeks after osteopathic treatment
Pain	Questionnaires: BPI	3 months after osteopathic treatment
Pain	Questionnaires: BPI	6 months after osteopathic treatment
Pain	Questionnaires: BPI	1 year after osteopathic treatment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, France
• Investigators: Principal Investigator: Serge PERROT, PU-PH, + 33 1.42.34.84.49

Publications and helpful links

General Publications

• Coste J, Medkour T, Maigne JY, Perez M, Laroche F, Perrot S. Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial. Ther Adv Musculoskelet Dis. 2021 Apr 16;13:1759720X211009017. doi: 10.1177/1759720X211009017. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2015
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimated): January 21, 2015

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: pain; quality of life; Fibromyalgia syndrome; osteopathic treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Myofascial Pain Syndromes; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: P130605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO