A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 101
- Locations
- 2
- Primary Endpoint
- Evaluation of pain during the 6 weeks of osteopathic treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Osteopathy +
75 patients will make 6 osteopathic sessions
Intervention: Osteopathic treatment (Procedure)
Osteopathy -
75 patients will make 6 factitious osteopathic sessions
Intervention: Factitious osteopathic treatment (Procedure)
Outcomes
Primary Outcomes
Evaluation of pain during the 6 weeks of osteopathic treatment
Time Frame: 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 Outcomes
- Quality of life(1 year after osteopathic treatment)
- Pain(1 year after osteopathic treatment)
- Fatigue(1 year after osteopathic treatment)
- Quality of life(3 months after osteopathic treatment)
- Quality of life(6 months after osteopathic treatment)
- Quality of life(6 weeks after osteopathic treatment)
- Fatigue(3 months after osteopathic treatment)
- Fatigue(6 weeks after osteopathic treatment)
- Fatigue(6 months after osteopathic treatment)
- Pain(6 weeks after osteopathic treatment)
- Pain(3 months after osteopathic treatment)
- Pain(6 months after osteopathic treatment)