Osteopathic Support Evaluation of Fibromyalgia Patients

Fibromyalgia Clinical Trial

— FMostéo  

Official title:

Osteopathic Support Evaluation of Fibromyalgia Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02805673
• Other study ID #: 2014-A00687-40
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 2021
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Procedure:
• Osteopathy

Locations

Country	Name	City	State
France	CHU Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for pain		chenge between Day 232 - Day 0
Secondary	Visual Analogue Scale for pain		change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0
Secondary	QDSA score		at day 232 until day 301 and compared to day 0
Secondary	SF-36 score		at day 232 until day 301 and compared to day 0
Secondary	number of tender points		at day 232 to day 301 and compared to day 0