Osteopathic Medicine in Fibromyalgia Syndrome

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

Detailed Description
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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

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

Conditions
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Fibromyalgia Syndrome

Intervention / Treatment
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* Procedure: Osteopathic treatment
* Procedure: Factitious osteopathic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient Male or female aged at least of 18 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 Patient suffering from fibromyalgia for over a year Patient with stable medical/non medical treatment for at least 1 month before the recruitment Patient referred to a medical center for a multidisciplinary approach Patient who can be followed for at least 12 months after the end of the osteopathic sessions Patient giving his informed consent to participate in the study Patient affiliated to or beneficiary of social insurance Exclusion Criteria: Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine) Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu Severe psychiatric pathology : major depression, psychosis Pregnancy or breast feeding The patient is already included in another clinical study Patient under judicial protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia syndrome, pain, quality of life, osteopathic treatment