Trial record 35 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

Osteopathic Medicine in Fibromyalgia Syndrome (FIBROPATHIC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02343237
First received: January 15, 2015
Last updated: NA
Last verified: December 2014
History: No changes posted
  Purpose

The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.


Condition Intervention
Fibromyalgia Syndrome
Procedure: Osteopathic treatment
Procedure: Factitious osteopathic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evaluation of pain during the 6 weeks of osteopathic treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100).


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)

  • Quality of life [ Time Frame: 3 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: FIQ and SF-36

  • Quality of life [ Time Frame: 6 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: FIQ and SF-36

  • Quality of life [ Time Frame: 1 year after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: FIQ and SF-36

  • Fatigue [ Time Frame: 6 weeks after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: multidimensional fatigue inventory (MFI) scale

  • Fatigue [ Time Frame: 3 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: MFI scale

  • Fatigue [ Time Frame: 6 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: MFI scale

  • Fatigue [ Time Frame: 1 year after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: MFI scale

  • Pain [ Time Frame: 6 weeks after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: Brief Pain Inventory (BPI)

  • Pain [ Time Frame: 3 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: BPI

  • Pain [ Time Frame: 6 months after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: BPI

  • Pain [ Time Frame: 1 year after osteopathic treatment ] [ Designated as safety issue: No ]
    Questionnaires: BPI


Estimated Enrollment: 150
Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteopathy +
75 patients will make 6 osteopathic sessions
Procedure: Osteopathic treatment
osteopathic sessions of 20 minutes
Active Comparator: Osteopathy -
75 patients will make 6 factitious osteopathic sessions
Procedure: Factitious osteopathic treatment
6 factitious osteopathic sessions of 20 minutes

Detailed Description:

An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.

This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.

This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.

The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).

The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.

This study will also allow to identify the profile of the osteopathic treatment responders patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient Male or female aged at least of 18
  2. Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
  3. Patient suffering from fibromyalgia for over a year
  4. Patient with stable medical/non medical treatment for at least 1 month before the recruitment
  5. Patient referred to a medical center for a multidisciplinary approach
  6. Patient who can be followed for at least 12 months after the end of the osteopathic sessions
  7. Patient giving his informed consent to participate in the study
  8. Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

  1. Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
  2. Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
  3. Severe psychiatric pathology : major depression, psychosis
  4. Pregnancy or breast feeding
  5. The patient is already included in another clinical study
  6. Patient under judicial protection
  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: NCT02343237

Contacts
Contact: Serge PERROT, PU-PH, MD, PhD, Prof +33 1.42.34.78 50 serge.perrot@htd.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Hotel-Dieu Hospital Not yet recruiting
Paris, Ile-de-France, France, 75004
Contact: Serge PERROT, PU-PH    + 33 1.42.34.78 50    serge.perrot@htd.aphp.fr   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Serge PERROT, PU-PH + 33 1.42.34.84.49
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02343237     History of Changes
Other Study ID Numbers: P130605
Study First Received: January 15, 2015
Last Updated: January 15, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fibromyalgia syndrome
pain
quality of life
osteopathic treatment

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

ClinicalTrials.gov processed this record on August 27, 2015