Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Baseline Mechanical Pain Threshold
研究概览
简要总结
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
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).
It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.
Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
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.
结局指标
主要结局
Baseline Mechanical Pain Threshold
时间窗: baseline at 0 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Baseline Tactile Threshold
时间窗: baseline at 0 min
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline Muscle Strength
时间窗: Baseline at 0 min
The muscle strength will be measured with a dynamometer and will be expressed in Newton
Mechanical Pain Threshold after treatment at 30 min
时间窗: Immediately after treatment at 30 min
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Tactile Threshold after treatment at 30 min
时间窗: Immediately after treatment at 30 min
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Muscle Strength after treatment at 30 min
时间窗: Immediately after treatment at 30 min
The muscle strength will be measured with a dynamometer and will be expressed in Newton
次要结局
- Change from baseline in Mechanical Pain Threshold(baseline at 0 min, immediately after treatment at 30 min)
- Change from baseline in TactileThreshold(baseline at 0 min, immediately after treatment at 30 min)
- Change from baseline in Muscle strength(baseline at 0 min, immediately after treatment at 30 min)