Osteopathic Support Evaluation of Fibromyalgia Patients

NCT02805673 | Unknown

• 1 other identifier: 2014-A00687-40
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Osteopathy; Support; Treatment; Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for pain

  chenge between Day 232 - Day 0

Secondary Outcomes (4)

• 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

• QDSA score

  at day 232 until day 301 and compared to day 0

• SF-36 score

  at day 232 until day 301 and compared to day 0

• number of tender points

  at day 232 to day 301 and compared to day 0

Study Arms (2)

OSTEO group

EXPERIMENTAL

usual medical treatment + 6 osteopathic interventions

Procedure: Osteopathy

witness group

NO INTERVENTION

usual medical treatment

Interventions

Osteopathy PROCEDURE

OSTEO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Women Pregnant or nursing.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, 14000, France

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Osteopathic Physicians

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Françoise CF COURTHEOUX, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: June 20, 2016
• Study Start: October 1, 2014
• Primary Completion: January 21, 2020
• Study Completion: January 1, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

FR (1)