Clinical trial NCT02343237: Osteopathic Medicine in Fibromyalgia Syndrome
Official title: A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia syndrome
pain
quality of life
osteopathic treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of pain during the 6 weeks of osteopathic treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 6 weeks after osteopathic treatment
measure: Quality of life
timeFrame: 3 months after osteopathic treatment
measure: Quality of life
timeFrame: 6 months after osteopathic treatment
measure: Quality of life
timeFrame: 1 year after osteopathic treatment
measure: Fatigue
timeFrame: 6 weeks after osteopathic treatment
measure: Fatigue
timeFrame: 3 months after osteopathic treatment
measure: Fatigue
timeFrame: 6 months after osteopathic treatment
measure: Fatigue
timeFrame: 1 year after osteopathic treatment
measure: Pain
timeFrame: 6 weeks after osteopathic treatment
measure: Pain
timeFrame: 3 months after osteopathic treatment
measure: Pain
timeFrame: 6 months after osteopathic treatment
measure: Pain
timeFrame: 1 year after osteopathic treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Hotel-Dieu Hospital
state: Ile-de-France
Study officials:
affiliation: + 33 1.42.34.84.49
name: Serge PERROT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: