Osteopathic Medicine in Fibromyalgia Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02343237
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Osteopathic Medicine in Fibromyalgia Syndrome FIBROPATHIC
• Scientific title: A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
• Date of first enrolment: December 2, 2015
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02343237
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Serge PERROT, PU-PH
• Affiliation: + 33 1.42.34.84.49

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fibromyalgia Syndrome

Intervention(s)

Procedure: Osteopathic treatment

Procedure: Factitious osteopathic treatment

Primary Outcome(s)

Evaluation of pain during the 6 weeks of osteopathic treatment [Time Frame: 6 weeks]

Secondary Outcome(s)

Fatigue [Time Frame: 3 months after osteopathic treatment]

Pain [Time Frame: 1 year after osteopathic treatment]

Quality of life [Time Frame: 1 year after osteopathic treatment]

Pain [Time Frame: 3 months after osteopathic treatment]

Quality of life [Time Frame: 6 weeks after osteopathic treatment]

Quality of life [Time Frame: 3 months after osteopathic treatment]

Fatigue [Time Frame: 6 months after osteopathic treatment]

Pain [Time Frame: 6 months after osteopathic treatment]

Fatigue [Time Frame: 1 year after osteopathic treatment]

Pain [Time Frame: 6 weeks after osteopathic treatment]

Fatigue [Time Frame: 6 weeks after osteopathic treatment]

Quality of life [Time Frame: 6 months after osteopathic treatment]

Secondary ID(s)

P130605

Source(s) of Monetary Support

Please refer to primary and secondary sponsors