Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia syndrome, pain, quality of life, osteopathic treatment
Brief 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
Interventions
PROCEDUREOsteopathic treatment
osteopathic sessions of 20 minutes
PROCEDUREFactitious osteopathic treatment
6 factitious osteopathic sessions of 20 minutes
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pain during the 6 weeks of osteopathic treatment | 6 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 6 weeks after osteopathic treatment | Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey) |
| Fatigue | 6 weeks after osteopathic treatment | Questionnaires: multidimensional fatigue inventory (MFI) scale |
| Pain | 6 weeks after osteopathic treatment | Questionnaires: Brief Pain Inventory (BPI) |
Countries
France
Outcome results
None listed