Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Latency of Antidromic median sensory nerve action potential
研究概览
简要总结
High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.
详细描述
The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.
However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
- •Tolerance to the application of electrotherapy.
- •That they have not diagnosed any pathology.
- •They do not present a contraindication to puncture and / or the application of electric currents.
排除标准
- •Neuromuscular disease.
- •Epilepsy.
- •Trauma, surgery or pain affecting the upper limb
- •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
Latency of Antidromic median sensory nerve action potential
时间窗: Baseline at 0 minutes
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.
Amplitude of Antidromic median sensory nerve action potential
时间窗: Baseline at 0 minutes
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.
Tactile Threshold
时间窗: Immediately after treatment at 30 minutes
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Pressure Pain Threshold
时间窗: Immediately after treatment at 30 minutes
The PPT will be measured with an algometer and will be expressed in Newtons
Muscle strength
时间窗: Immediately after treatment at 30 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Latency Antidromic median sensory nerve action potential
时间窗: Immediately after treatment at 30 minutes
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.
Amplitude Antidromic median sensory nerve action potential
时间窗: Immediately after treatment at 30 minutes
The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.
次要结局
- Baseline nerve temperature(Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes)
- Numerical Discomfort Rate Score(After the intervention at 35 minutes)
- Numerical Pain Rate Score(After the intervention at 35 minutes)
- Number of participants with intervention-related adverse effects(After the intervention at 35 minutes)
- Blinding success(After the intervention at 35 minutes)