FIBROPATHIC: Osteopathic Medicine in Fibromyalgia Syndrome

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02343237

Collaborator

(none)

101

Enrollment

Location

Arms

31.8

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Procedure: Osteopathic treatment Procedure: Factitious osteopathic treatment	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome

Actual Study Start Date :

Dec 2, 2015

Actual Primary Completion Date :

Jul 20, 2017

Actual Study Completion Date :

Jul 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Osteopathy + 75 patients will make 6 osteopathic sessions	Procedure: Osteopathic treatment osteopathic sessions of 20 minutes
Active Comparator: Osteopathy - 75 patients will make 6 factitious osteopathic sessions	Procedure: Factitious osteopathic treatment 6 factitious osteopathic sessions of 20 minutes

Arm

Intervention/Treatment

Experimental: Osteopathy +

75 patients will make 6 osteopathic sessions

Procedure: Osteopathic treatment

osteopathic sessions of 20 minutes

Active Comparator: Osteopathy -

75 patients will make 6 factitious osteopathic sessions

Procedure: Factitious osteopathic treatment

6 factitious osteopathic sessions of 20 minutes

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Quality of life [6 weeks after osteopathic treatment]
Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)
Quality of life [3 months after osteopathic treatment]
Questionnaires: FIQ and SF-36
Quality of life [6 months after osteopathic treatment]
Questionnaires: FIQ and SF-36
Quality of life [1 year after osteopathic treatment]
Questionnaires: FIQ and SF-36
Fatigue [6 weeks after osteopathic treatment]
Questionnaires: multidimensional fatigue inventory (MFI) scale
Fatigue [3 months after osteopathic treatment]
Questionnaires: MFI scale
Fatigue [6 months after osteopathic treatment]
Questionnaires: MFI scale
Fatigue [1 year after osteopathic treatment]
Questionnaires: MFI scale
Pain [6 weeks after osteopathic treatment]
Questionnaires: Brief Pain Inventory (BPI)
Pain [3 months after osteopathic treatment]
Questionnaires: BPI
Pain [6 months after osteopathic treatment]
Questionnaires: BPI
Pain [1 year after osteopathic treatment]
Questionnaires: BPI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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