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
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|
|Intervention Model:||Parallel Assignment|
|Actual Study Start Date :||April 27, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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
- Effect of otherapy on the health of patients with fibromyalgia syndrome [ Time Frame: 3 months ]
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
|Contact: Mireille Michel-Cherqui, MD||+33(0)firstname.lastname@example.org|
|Suresnes, France, 92150|
|Contact: Mireille Michel-Cherqui, MD +33(0)146252985 email@example.com|
|Principal Investigator:||Mireille Michel-Cherqui, MD||Hopital Foch|