Effects of Far Infrared Radiation on Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- SS
研究概览
简要总结
This study aimed to evaluate the effectiveness of infrared radiation in improving the various symptoms of fibromyalgia syndrome, by using a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic, as well as the adherence to it and its applicability in daily routines.
A prospective, experimental, randomized, and double-blind study was carried. The study was implemented over 7 months, with a total of 5 visits for each patient. Participants were randomly allocated in experimental or control group. Those included in the experimental group received a shirt impregnated with ceramic emitting long infrared waves while participants in the placebo group received an exactly looking shirt, but not impregnated with ceramic emitting long infrared waves. Each visit comprised clinical evaluation and self-report scales filling (WPS, SS and FIQR scales).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age superior to 18 years-old
- •ability to freely sign the informed consent form
- •generalized pain index scores (WPI ≥ 7 and SS score ≥ 5, or WPI ≥ 3 and ≤ 6 with SS ≥ 9, presence of abdominal pain and / or with depression and / or headache, in the last 6 months, at the screening consultation).
排除标准
- •dermatological diseases
- •Other rheumatic and /or autoimmune diseases
结局指标
主要结局
SS
时间窗: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
The symptom severity score (SS) quantifies symptom severity on a 0-12 scale by assessing problems with fatigue, cognitive dysfunction and unrefreshed sleep over the past week. These scores are summed for a measure of the physician's impression of the number of somatic symptoms the patient has on a 0-3 scale.
WPI
时间窗: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
The widespread pain index (WPI) is a 19-point checklist (score range: 0-19) that assesses the presence of pain or tenderness score means (within the prior seven days) in 19 specific areas of the body; each affected area receives one point.
次要结局
- Tender Points(Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.)
- FIQR(Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.)
- EQ-5D(Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.)