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Auriculotherapy Treatment in Fibromyalgia (Fib-Auric)

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ClinicalTrials.gov Identifier: NCT02764788
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one of the most frequent causes of referral to the pain management unit. It affects mainly women; they are referred by a rheumatologist, an internal medicine physician or by their family physician.

FM produces various degrees of disability and pain, and has an important impact on quality of life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack of efficacy of pharmacological treatments make management of FM a very difficult task. In France the consensus includes limitation of pharmacological treatment, encouraging physical rehabilitation and referring the patients to a specialized pain clinic where multidisciplinary management will be undertaken. In our hospital the investigators favor non pharmacological therapies and propose to the FM patients to learn relaxation and self-hypnosis, physical rehabilitation and use of trans cutaneous electrical neurostimulation.

Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a microsystem which reflects the entire body, represented on the auricle, the outer portion of the ear. Mapping of the auricle has been described, according to the fact that pathology of different organs can induce specific changes in the auricle, for example color change or sensitivity. Treating specific areas, which somehow would be "connected" to the affected organ could also improve the functioning of the body or relieve pain. AT uses placement of needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the effectiveness of ATis currently supported by randomized controlled trials. It is validated by WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.

The investigators regularly use AT in FM patients in our pain management unit to alleviate symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire) following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same tests.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Specific auriculotherapy Other: non-specific auriculotherapy Other: seed auriculotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : April 27, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Specific auriculotherapy
Auriculotherapy on specific points with needles
Other: Specific auriculotherapy
Specific auriculotherapy with needles

Sham Comparator: Non-specific auriculotherapy
Auriculotherapy on non-specific auriculotherapy points with needles
Other: non-specific auriculotherapy
non-specific auriculotherapy with needles

Placebo Comparator: Seed auriculotherapy
Auriculotherapy on non-specific auriculotherapy points with seeds
Other: seed auriculotherapy
non-specific auriculotherapy with seeds




Primary Outcome Measures :
  1. Effect of otherapy on the health of patients with fibromyalgia syndrome [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fibromyalgia (criteria from ACR)

Exclusion Criteria:

  • history or existing of inflammatory rheumatims, lupus, systemic diseases that may explain the pain syndrom
  • history or existing of severe psychiatric desorder
  • history or existing of hemophilia
  • with anticoagulant treatment
  • local counterindication to auriculotherapy
  • valvular prosthesis
  • auriculotherapy during the last 12 months
  • new psychotherpeutic treatment which interfer with auriculotherapy
  • pregnancy
  • breath feeding
  • RMI for the next 5 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764788


Contacts
Contact: Mireille Michel-Cherqui, MD +33(0)146252985 m.michel-cherqui@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Mireille Michel-Cherqui, MD    +33(0)146252985    m.michel-cherqui@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Mireille Michel-Cherqui, MD Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02764788     History of Changes
Other Study ID Numbers: 2015/27
2015-A01842-47 ( Other Identifier: ANSM )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hopital Foch:
Auriculotherapy

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