search
Back to results

Osteopathic Support Evaluation of Fibromyalgia Patients (FMostéo)

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathy
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Osteopathy, Support, Treatment, Pain, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OSTEO group

witness group

Arm Description

usual medical treatment + 6 osteopathic interventions

usual medical treatment

Outcomes

Primary Outcome Measures

Visual Analogue Scale for pain

Secondary Outcome Measures

Visual Analogue Scale for pain
QDSA score
SF-36 score
number of tender points

Full Information

First Posted
January 18, 2016
Last Updated
January 22, 2020
Sponsor
University Hospital, Caen
search

1. Study Identification

Unique Protocol Identification Number
NCT02805673
Brief Title
Osteopathic Support Evaluation of Fibromyalgia Patients
Acronym
FMostéo
Official Title
Osteopathic Support Evaluation of Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Osteopathy, Support, Treatment, Pain, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSTEO group
Arm Type
Experimental
Arm Description
usual medical treatment + 6 osteopathic interventions
Arm Title
witness group
Arm Type
No Intervention
Arm Description
usual medical treatment
Intervention Type
Procedure
Intervention Name(s)
Osteopathy
Primary Outcome Measure Information:
Title
Visual Analogue Scale for pain
Time Frame
chenge between Day 232 - Day 0
Secondary Outcome Measure Information:
Title
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
Title
QDSA score
Time Frame
at day 232 until day 301 and compared to day 0
Title
SF-36 score
Time Frame
at day 232 until day 301 and compared to day 0
Title
number of tender points
Time Frame
at day 232 to day 301 and compared to day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise CF COURTHEOUX, MD
Organizational Affiliation
CHU Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Osteopathic Support Evaluation of Fibromyalgia Patients

We'll reach out to this number within 24 hrs