Osteopathic Medicine in Fibromyalgia Syndrome (FIBROPATHIC)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Fibromyalgia Syndrome

Treatments: Procedure: Factitious osteopathic treatment; Procedure: Osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02343237

P130605

Details and patient eligibility

About

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

Full 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

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

Osteopathy +

Experimental group

Description:

75 patients will make 6 osteopathic sessions

Treatment:

Procedure: Osteopathic treatment

Osteopathy -

Active Comparator group

Description:

75 patients will make 6 factitious osteopathic sessions

Treatment:

Procedure: Factitious osteopathic treatment