跳至主要内容
临床试验/NCT02764788
NCT02764788已完成不适用

Auriculotherapy Treatment in Fibromyalgia

Hopital Foch2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
100
试验地点
2
主要终点
Effect of otherapy on the health of patients with fibromyalgia syndrome

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • fibromyalgia (criteria from ACR)

排除标准

  • 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

结局指标

主要结局

Effect of otherapy on the health of patients with fibromyalgia syndrome

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Auriculotherapy Treatment in Fibromyalgia | 临床试验