Auriculotherapy Treatment in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

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.
    


Intervention name(s): Specific auriculotherapy; non-specific auriculotherapy; seed auriculotherapy
Intervention type(s): Other; Other; Other
Intervention description(s): Specific auriculotherapy with needles; non-specific auriculotherapy with needles; non-specific auriculotherapy with seeds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Auriculotherapy