Auriculotherapy Treatment in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: seed auriculotherapyOther: Specific auriculotherapyOther: non-specific auriculotherapy
- Registration Number
- NCT02764788
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- fibromyalgia (criteria from ACR)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seed auriculotherapy seed auriculotherapy Auriculotherapy on non-specific auriculotherapy points with seeds Specific auriculotherapy Specific auriculotherapy Auriculotherapy on specific points with needles Non-specific auriculotherapy non-specific auriculotherapy Auriculotherapy on non-specific auriculotherapy points with needles
- Primary Outcome Measures
Name Time Method Effect of otherapy on the health of patients with fibromyalgia syndrome 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopital Foch
🇫🇷Suresnes, France