Influence of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
研究概览
简要总结
Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy asymptomatic subjects
- •Aged 18 to 40 years
- •Both genders
排除标准
- •Belonephobia or fear of needles
- •Neurological, cardiovascular or metabolic diseases
- •Any pathology or process that causes pain
- •Cutaneous alterations
- •Pregnancy
- •Cognitive and sensitivity disorders
- •Fibromyalgia
- •Frequent or recent (24 hours before) intake of alcohol and other drugs
- •Have received pharmacological, physiotherapeutic or other treatment in the last week
- •Intake of caffeine in the two hours prior to measurement
- •Vigorous physical activity on the day of testing
研究组 & 干预措施
Needling Group
The needle will be inserted for 90 seconds without galvanic current.
干预措施: Isolated needling procedure (Procedure)
Low intensity percutaneous electrolysis
A single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
干预措施: Low intensity percutaneous electrolysis (Procedure)
High intensity percutaneous electrolysis
Three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.
干预措施: High intensity percutaneous electrolysis (Procedure)
结局指标
主要结局
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
时间窗: Baseline and immediately after the intervention
Assessed by algometry. Conditioning stimulus: pressure cuff on the arm. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
次要结局
- Change from baseline Pressure Pain Thresholds immediately after the intervention(Baseline and immediately after the intervention)
- Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention(Baseline and immediately after the intervention)
研究者
Sergio Varela Rodríguez
PhD candidate
University of Salamanca