Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study
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
- 否
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
