Effect of Anti-Depressants vs Physiotherapy in Management of Fibromyalgia Syndrome: What Predicts a Clinical Benefit?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Reduction in FIQ score from the baseline
研究概览
简要总结
To compare the efficacy of physiotherapy and anti-depressants in disability reduction in patients of Fibromyalgia syndrome.
详细描述
Research Question:
Does the use of physiotherapy or pharmacotherapy help in improving quality of life in patients of fibromyalgia as judged by fibromyalgia impact questionnaire at a 6 month follow up period?
Study hypothesis:
Physiotherapy is no better than pharmacotherapy in improving the quality of life in patients of fibromyalgia as judged by fibromyalgia impact questionnaire.
Study type- Interventional STUDY DESIGN: open label alternate patient treatment allocation Ethical approval for the trial protocol has been obtained from the institute's ethics committee of Mahatma Gandhi Institute of Medical Sciences, Sevagram.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's between 18-60 yrs, belonging to either sex. With symptoms of chronic muscular pain of at least 12 weeks (that may or may not be consecutive) who fulfill the American College of Rheumatology (ACR) criteria for the diagnosis of Fibromyalgia
排除标准
- •Patients of age group more than 60 yrs and below 18 years
- •Pregnant or lactating females.
- •Patients with a history of trauma.
- •Patients with severe co morbid illness which prevents physical activity (for example, cardiovascular problems)
- •Patients with the presence of specific medical disorders which require immediate treatment (for example, fractures, infectious diseases),
- •Patients with associated neurological abnormality
研究组 & 干预措施
2
anti-depressants
干预措施: Amitryptiline (Drug)
1
physiotherapy
干预措施: Physiotherapy (Procedure)
结局指标
主要结局
Reduction in FIQ score from the baseline
时间窗: Two years
次要结局
- Reduction in Tender point score(Two years)
- Reduction in Brief psychiatric rating score(Two Years)