Osteopathic Support Evaluation of Fibromyalgia Patients

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Procedure: Osteopathy

• Registration Number: NCT02805673
• Lead Sponsor: University Hospital, Caen

Brief Summary

At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.

The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Status Verified: 2020-01
• Primary Completion: 2020-01-21
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• FM patient diagnosed according to the ACR criteria.
• Patient Having realized biological balances excluding any underlying pathology that may be causing the pain.
• Patient Over 18 years followed at Caen University Hospital.
• Patient Treated with drugs to its FM.
• Patient Being informed and having signed his consent.
• Patient Affiliated to the social security system.
• French-Patient.

Exclusion Criteria

• FM undiagnosed according to the ACR criteria.
• Patient Showing against -indications to the osteopathic surgery.
• Patient Treated by manual therapy ( physiotherapy, osteopathy, acupuncture... ) during the trial and during the three months preceding the study.
• Concomitant Maladie (type cancers, cardiovascular diseases, rheumatic diseases ) or all diseases causing bone pain and myalgia.
• Important Surgery of less than 3 months.
• Inability to submit to medical monitoring study for geographical or social reasons.
• Inclusion The subject in another biomedical research protocol for this study.
• Women Pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSTEO group	Osteopathy	usual medical treatment + 6 osteopathic interventions

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for pain	chenge between Day 232 - Day 0

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale for pain	change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0
number of tender points	at day 232 to day 301 and compared to day 0
QDSA score	at day 232 until day 301 and compared to day 0
SF-36 score	at day 232 until day 301 and compared to day 0

Trial Locations

Locations (1)

CHU Caen; 🇫🇷 Caen, France