The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
osteopathic sessions of 20 minutes
6 factitious osteopathic sessions of 20 minutes
Hotel-Dieu Hospital
Paris, Île-de-France Region, France
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).
Time frame: 6 weeks
Quality of life
Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)
Time frame: 6 weeks after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Time frame: 3 months after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Time frame: 6 months after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Time frame: 1 year after osteopathic treatment
Fatigue
Questionnaires: multidimensional fatigue inventory (MFI) scale
Time frame: 6 weeks after osteopathic treatment
Fatigue
Questionnaires: MFI scale
Time frame: 3 months after osteopathic treatment
Fatigue
Questionnaires: MFI scale
Time frame: 6 months after osteopathic treatment
Fatigue
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Questionnaires: MFI scale
Time frame: 1 year after osteopathic treatment
Pain
Questionnaires: Brief Pain Inventory (BPI)
Time frame: 6 weeks after osteopathic treatment
Pain
Questionnaires: BPI
Time frame: 3 months after osteopathic treatment
Pain
Questionnaires: BPI
Time frame: 6 months after osteopathic treatment
Pain
Questionnaires: BPI
Time frame: 1 year after osteopathic treatment