Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Thermal Pain Threshold During Treatment
研究概览
简要总结
The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.
详细描述
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents)
This evidences in animals could have application in pain treatment, characterized by overactive nervous system. For this reason it was decided to compare the effects on experimental pain and peripheral nerve conduction of this new electric current versus sham stimulation and TENS (Transcutaneous Electrical Nerve Stimulation).
The scientific literature on transcutaneous electrical stimulation in humans and changes in nerve conduction and / or somatosensory thresholds focuses mainly on TENS (Transcutaneous Electrical Nerve Stimulation). Therefore TENS is a good reference standard to compare the effect of this new currents.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
排除标准
- •Neuromuscular disease.
- •Epilepsy.
- •Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- •Osteosynthesis material in the upper limb.
- •Diabetes.
- •Cardiovascular disease.
- •Pacemaker or other implanted electrical device.
- •Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
- •Presence of tattoos or other external agent introduced into the treatment or assessment area.
- •Pregnancy.
- •Sensitivity disturbance in upper limb.
结局指标
主要结局
Thermal Pain Threshold During Treatment
时间窗: during treatment at 15 min.
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Mechanical Pain Threshold During Treatment
时间窗: during treatment at 15 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Nerve Conduction Latency Immediately After Treatment
时间窗: immediately after treatment at 20 min.
The compound action potential latencies will be measured and will be expressed in ms.
Tactile Threshold During Treatment
时间窗: during treatment at 15 min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
次要结局
- Change Current Density (mA/cm2)(at 1 min. treatment session, at 20 min. treatment session)
- Nerve Conduction Latency Post-treatment 20 Min.(at 20 min. post-treatment)
- Nerve Conduction Latency Post-treatment 40 Min.(at 40 min. post-treatment)
- Habituation to Electrical Stimulation(Start treatment session (1 min), end treatment session (20 min))
- Change From Baseline in Nerve Conduction Amplitude ( µV)(Baseline,immediately after treatment at 20 min..)
- Mechanical Pain Threshold Post-treatment 20 Min.(at 20 min. post-treatment)
- Baseline Thermal Pain Threshold(Baseline at 0 min.)
- Thermal Pain Threshold Post-treatment 20 Min.(at 20 min. post-treatment)
- Baseline Tactile Threshold(Baseline at 0 min.)
- Perception Current Comfortability(At the end of the third experimental session, 3 days)
- Mechanical Pain Threshold Post-treatment 40 Min.(at 40 min. post-treatment)
- Tactile Threshold Post-treatment 20 Min.(at 20 min. post-treatment)
- Tactile Threshold Post-treatment 40 Min.(at 40 min. post-treatment)
- Baseline Mechanical Pain Threshold(Baseline at 0 min.)
- Thermal Pain Threshold Post-treatment 40 Min.(at 40 min. post-treatment)
- Baseline Nerve Conduction Latency(Baseline at 0 min.)