Trial record 40 of 113 for:    fibromyalgia | Open Studies

Osteopathic Support Evaluation of Fibromyalgia Patients (FMostéo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT02805673
First received: January 18, 2016
Last updated: June 15, 2016
Last verified: June 2016
  Purpose

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 Intervention
Fibromyalgia
Procedure: Osteopathy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Osteopathic Support Evaluation of Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

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

Secondary Outcome Measures:
  • 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 ]
  • QDSA score [ Time Frame: at day 232 until day 301 and compared to day 0 ]
  • SF-36 score [ Time Frame: at day 232 until day 301 and compared to day 0 ]
  • number of tender points [ Time Frame: at day 232 to day 301 and compared to day 0 ]

Estimated Enrollment: 44
Study Start Date: October 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OSTEO group
usual medical treatment + 6 osteopathic interventions
Procedure: Osteopathy
No Intervention: witness group
usual medical treatment

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02805673

Contacts
Contact: Françoise CF COURTHEOUX, MD 02.31.06.47.55 ext + 33 courtheoux-f@chu-caen.fr
Contact: Cathy GC Gaillard 02 31 06 53 49 ext +33 gaillard-c@chu-caen.fr

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

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02805673     History of Changes
Other Study ID Numbers: 2014-A00687-40 
Study First Received: January 18, 2016
Last Updated: June 15, 2016

Keywords provided by University Hospital, Caen:
Osteopathy
Support
Treatment
Pain
Quality of Life

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

ClinicalTrials.gov processed this record on January 19, 2017