Osteopathic Medicine in Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

— FIBROPATHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343237
• Other study ID #: P130605
• Status: Completed
• Phase: N/A
• Start date: December 2, 2015
• Est. completion date: July 27, 2018

Study information

• Verified date: April 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 27, 2018
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Procedure:
• Osteopathic treatment
osteopathic sessions of 20 minutes
• Factitious osteopathic treatment
6 factitious osteopathic sessions of 20 minutes

Locations

Country	Name	City	State
France	Hotel-Dieu Hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain during the 6 weeks of osteopathic treatment	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).	6 weeks
Secondary	Quality of life	Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)	6 weeks after osteopathic treatment
Secondary	Quality of life	Questionnaires: FIQ and SF-36	3 months after osteopathic treatment
Secondary	Quality of life	Questionnaires: FIQ and SF-36	6 months after osteopathic treatment
Secondary	Quality of life	Questionnaires: FIQ and SF-36	1 year after osteopathic treatment
Secondary	Fatigue	Questionnaires: multidimensional fatigue inventory (MFI) scale	6 weeks after osteopathic treatment
Secondary	Fatigue	Questionnaires: MFI scale	3 months after osteopathic treatment
Secondary	Fatigue	Questionnaires: MFI scale	6 months after osteopathic treatment
Secondary	Fatigue	Questionnaires: MFI scale	1 year after osteopathic treatment
Secondary	Pain	Questionnaires: Brief Pain Inventory (BPI)	6 weeks after osteopathic treatment
Secondary	Pain	Questionnaires: BPI	3 months after osteopathic treatment
Secondary	Pain	Questionnaires: BPI	6 months after osteopathic treatment
Secondary	Pain	Questionnaires: BPI	1 year after osteopathic treatment