Osteopathic Support Evaluation of Fibromyalgia Patients

NCT ID: NCT02805673

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-01-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OSTEO group

usual medical treatment + 6 osteopathic interventions

Group Type: EXPERIMENTAL

Osteopathy

Intervention Type: PROCEDURE

witness group

usual medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Françoise CF COURTHEOUX, MD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

CHU Caen

Caen, , France

Countries

France

Other Identifiers

2014-A00687-40

Identifier Type: -

Identifier Source: org_study_id