A Randomized Controlled Trial on the Effectiveness of Mild Water-Filtered Near Infrared Hyperthermia as an Adjunct to a Standard Multimodal Rehabilitation in the Treatment of Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- affective pain (German version of the McGill Pain Questionnaire)
研究概览
简要总结
The purpose of the study is to evaluate whether mild walter-filtered near infrared hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal rehabilitation compared to standard multimodal rehabilitation only in patients with fibromyalgia.
详细描述
Mild systemic heat agents, including infrared whole-body hyperthermia, are used as treatment options in multimodal rehabilitation programs for fibromyalgia in Germany. However, no randomized controlled clinical trial exists on their effectiveness for this condition.
This study is designed as an add-on study to evaluate the additional benefit of mild walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program compared to a standard multimodal rehabilitation program only. Standard multimodal rehabilitation is configured as usually applied in clinical trials with exercise, cognitive behavioral therapy, and health education as the main treatment components.
Mild walter-filtered near infrared hyperthermia (heating-up to 38.1 degrees C body core temperature followed by a 15-min heat retention period) is administered twice a week over 3 weeks during a rehabilitation hospital stay.
Primary outcome measures are measured at baseline, postintervention, 3 and 6 months postintervention. Analysis is done by intention to treat, for significance testing Repeated Measures ANCOVA is used.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must meet the American College of Rheumatology 1990 criteria for fibromyalgia
- •participants must report a score ≥ 4 on the pain intensity subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
- •participants must report a score ≥ 4 on the normalized physical functioning subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
- •participants must be aged between 18 and 70 years
排除标准
- •severe cardiovascular disease
- •metabolic disease
- •nervous system disorder
- •blood coagulation disease
- •acute inflammatory disease
- •status after organ transplantation
- •reduced general health (Karnofsky Index ≤ 50)
- •pregnant women
- •breast feeding women
- •persons involved in a pending litigation for early pensioning due to fibromyalgia
- •persons planning to apply for a pension due to fibromyalgia
结局指标
主要结局
affective pain (German version of the McGill Pain Questionnaire)
sensory pain (German version of the McGill Pain Questionnaire)
次要结局
- pain intensity (visual analogue scale)
- Fibromyalgia related quality of life(German version of the Fibromyalgia Impact Questionnaire)
- tender point assessment(mean tender point pain threshold, total tender point intensity, tender point count)
- adverse events, side effects