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临床试验/NCT04421521
NCT04421521Unknown不适用

Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 44 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
44
主要终点
Pain Score

研究概览

简要总结

patients suffering from fibromyalgia syndrome according to the criteria of the American College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will be identified, according to the Traditional Chinese Medicine rules, acupuncture will be planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy. Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28 days follow-up.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of Fibromyalgia

排除标准

  • coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator

结局指标

主要结局

Pain Score

时间窗: 28 days after the completion of the treatment

Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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