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Completed

NCT Number: NCT02764788

Auriculotherapy Treatment in Fibromyalgia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific auriculotherapy

Other

Specific auriculotherapy with needles

Non-specific auriculotherapy

Other

non-specific auriculotherapy with needles

seed auriculotherapy

Other

non-specific auriculotherapy with seeds

Primary outcomes

  1. Effect of otherapy on the health of patients with fibromyalgia syndrome

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Fib-Auric

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 6, 2016
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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