The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain and stiffness
研究概览
简要总结
Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes considerable costs in primary health care setting as well as specialized medical care sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is sparse knowledge about the effects of long-term RCTs in the treatment of pain in fibromyalgia, as there are no publications about cost-effectiveness analysis of such treatments.
The aim of this study is to investigate whether the BEMER electromagnetic field therapy device has beneficial long-term effects in the treatment of pain, and whether it improves fibromyalgia patients' quality of life. In addition, this study investigates whether the BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.
详细描述
The participants of this study are working age female patients from the Central Finland Health Care District, and who have been treating because of severe pain. After eligibility has been assessed by health-related questionnaire and clinical examination, the participants will be randomly assigned into the treatment or control group. Treatment group patients will receive the loan activated BEMER-care unit, while controls will receive inactivated sham BEMER-unit. All participants will use the device regularly on a daily bases over three months. After one month treatment break, the treatment group will become a control group and control group will become a treatment group according cross-over design principle. Switching the groups will take place by changing the BEMER devices during the break. Throughout the study, both participants and researchers are unaware whether the participants are using activated or inactivated BEMER-devices. The research will be carried out and coordinated by Central Finland Central Hospital, and the research project will take place between September 2014 and June 2018.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •diagnosis of fibromyalgia
- •chronic persistent moderate or severe pain for more than 12 months
- •average minimum pain intensity of 5 in the scale of 0 to 10 during the last 7 days
- •age between 18 and 60 years
- •female gender
排除标准
- •an inflammatory rheumatic disease
- •some other chronic pain disease as fibromyalgia
- •psychiatric illness
- •addiction to opiates
- •substance abuse
- •a person with disability
- •pregnancy and breast-feeding
研究组 & 干预措施
activated BEMER-device
Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
干预措施: BEMER electromagnetic field therapy (Device)
inactivated BEMER-device
Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
干预措施: BEMER electromagnetic field therapy (Device)
结局指标
主要结局
Pain and stiffness
时间窗: Change from Baseline Pain and Stiffness at 3 months
Visual Analogue Scale (VAS)
次要结局
- Cost-effectiveness(Three Months Before and After the Start of the Intervention)
- Severity of depression(Change from Baseline Severity of Depression at 3 Months)
- Quality of life(Change from Baseline Quality of Life at 3 month)
- Symptoms and functional ability(Change from Baseline Symptoms and Functional Ability at 3 months)