Trial record 37 of 109 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Osteopathic Support Evaluation of Fibromyalgia Patients (FMostéo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02805673
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Fibromyalgia Procedure: Osteopathy

Study Type : Interventional
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Osteopathic Support Evaluation of Fibromyalgia Patients
Study Start Date : October 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: OSTEO group
usual medical treatment + 6 osteopathic interventions
Procedure: Osteopathy
No Intervention: witness group
usual medical treatment

Primary Outcome Measures :
  1. Visual Analogue Scale for pain [ Time Frame: chenge between Day 232 - Day 0 ]

Secondary Outcome Measures :
  1. Visual Analogue Scale for pain [ Time Frame: change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0 ]
  2. QDSA score [ Time Frame: at day 232 until day 301 and compared to day 0 ]
  3. SF-36 score [ Time Frame: at day 232 until day 301 and compared to day 0 ]
  4. number of tender points [ Time Frame: at day 232 to day 301 and compared to day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02805673

Contact: Françoise CF COURTHEOUX, MD ext + 33
Contact: Cathy GC Gaillard 02 31 06 53 49 ext +33

CHU Caen Recruiting
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Principal Investigator: Françoise CF COURTHEOUX, MD CHU Caen

Responsible Party: University Hospital, Caen Identifier: NCT02805673     History of Changes
Other Study ID Numbers: 2014-A00687-40
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Caen:
Quality of Life

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases