NCT02231541已完成不适用
Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2014年9月1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
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
研究概览
简要总结
The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
- •Subjects aged between 18 and 60 years
排除标准
- •Pregnant patients
- •Patients with pacemaker or other metal implants
- •Systemic infectious disorders
- •Neoplastic disorders
- •Severe heart disease
结局指标
主要结局
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
时间窗: baseline, 4 weeks, 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
次要结局
- Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
medical director
University of Roma La Sapienza
研究点 (2)
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