Clinical Effects of a Single-session of Radiofrequency on Vascular Response and Pain Thresholds in Patients With Fibromyalgia: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Peripheral vascular blood flow
研究概览
简要总结
The aim of this study is to analyze the effects of a single-session of Radiofrequency in patients with Fibromyalgia in comparison to a placebo group.
详细描述
The aim of this study is to analyze the effects of a single-session of Radiofrequency on peripheral vascular blood flow of the skin of the hands and core body temperature in patients with Fibromyalgia in comparison to a placebo group. Also, to study the clinical effects of the intervention on subjective pain perception, pain threshold to pressure and electrical pain threshold and intensity.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Fibromyalgia in accordance with the American College of Rheumatology criteria for classifying Fibromyalgia (2016 revision) by a rheumatologist of the Public Health System of Andalusia (Spain)
- •Age from 18 to 70 years
- •No other rheumatic diseases
- •Absence of regular physical activity
- •Limitation of usual activities due to pain on at least 1 day out of the previous 30
排除标准
- •Presence of cardiac, renal or hepatic insufficiency;
- •Severe physical disability
- •Pregnancy or lactation
- •Active infections
- •Psychiatric illness
- •Active tumor.
- •Treatment with vasoactive drugs or anticoagulants or a history of drug use
- •Skin disorders
- •Any other non-pharmacological therapy
结局指标
主要结局
Peripheral vascular blood flow
时间窗: At the end of the radiofrequency session, an average of 20 minutes
Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow
次要结局
- Pain Threshold Electric Score(At the end of the radiofrequency session, an average of 20 minutes)
- Pain Intensity: Visual Analog Scale(At the end of the radiofrequency session, an average of 20 minutes)
- Pain Intensity Electric Score(At the end of the radiofrequency session, an average of 20 minutes)
- Core body temperature(At the end of the radiofrequency session, an average of 20 minutes)
- Pressure Pain Threshold(At the end of the radiofrequency session, an average of 20 minutes)
研究者
Encarnación Aguilar Ferrandiz
Research and teaching staff of the University of Granada
Universidad de Granada