Osteopathic Support Evaluation of Fibromyalgia Patients (FMostéo)

January 22, 2020 updated by: University Hospital, Caen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • CHU Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale for pain
Time Frame: chenge between Day 232 - Day 0
chenge between Day 232 - Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
at day 232 to day 301 and compared to day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Françoise CF COURTHEOUX, MD, CHU Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

January 21, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00687-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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