Comparison of the Effects of Transcutaneous vs. Percutaneous Electrical Nerve Stimulation on the Sensorimotor System of the Radial Nerve in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
This study aims to compare the effects of two types of electrical nerve stimulation techniques-Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS)-on the sensory and motor components of the radial nerve in healthy volunteers.
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, low-cost, and widely used electrotherapy technique that applies electrical currents through surface electrodes on the skin to relieve pain. Percutaneous Electrical Nerve Stimulation (PENS) is a minimally invasive technique that delivers the electrical current through fine needles inserted near a peripheral nerve, potentially producing stronger physiological effects.
In this randomized, double-blind controlled clinical trial, 120 healthy participants aged 18-60 years will be randomly assigned to one of four groups:
Transcutaneous Electrical Nerve Stimulation (TENS)
Percutaneous Electrical Nerve Stimulation (PENS)
Sham Transcutaneous Electrical Nerve Stimulation (TENS) (placebo)
Sham Percutaneous Electrical Nerve Stimulation (placebo)
Each participant will receive one 20-minute stimulation session. Outcomes will include:
Pressure pain threshold (PPT) (measured with an algometer),
Thermal pain threshold (measured with a thermode),
Maximal Isometric wrist extensor strength (measured with a hand-held dynamometer).
The goal is to determine whether Percutaneous Electrical Nerve Stimulation (PENS) produces greater changes in sensory and motor parameters than Transcutaneous Electrical Nerve Stimulation (TENS) and to evaluate differences compared to placebo. This research will improve understanding of the physiological effects of these commonly used electrotherapy modalities and support evidence-based decision-making in clinical practice.
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 aged between 18 and 60 years.
- •No history of musculoskeletal or neurological disorders.
- •No alterations in sensitivity in the upper limb.
- •Not taking any medication in the previous two weeks.
- •Able to understand the study procedures and provide informed consent.
排除标准
- •Any neurological or neuromuscular disease.
- •History of upper limb trauma, surgery, or persistent pain.
- •Contraindications to electrical stimulation or invasive techniques.
- •Presence of cardiac pacemaker, epilepsy, diabetes, cancer, or cardiovascular disease.
- •Skin lesions or infections in the stimulation area.
- •Pregnancy or suspected pregnancy.
研究组 & 干预措施
Transcutaneous Electrical Nerve Stimulation (TENS)
Participants will receive one session of Transcutaneous Electrical Nerve Stimulation (TENS) applied over the radial nerve using surface electrodes. Stimulation parameters: 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and intensity set at the individual tolerance threshold for 20 minutes.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Percutaneous Electrical Nerve Stimulation (PENS)
Participants will receive one session of Percutaneous Electrical Nerve Stimulation (PENS). A sterile 0.30 × 50 millimeter (mm) needle will be inserted near the radial nerve under ultrasound guidance. Stimulation parameters: 2 Hertz (Hz) frequency, 250 microseconds (µs) pulse width, and intensity set at the individual tolerance threshold for 20 minutes.
干预措施: Percutaneous Electrical Nerve Stimulation (PENS) (Device)
Sham TENS
Participants will undergo a sham Transcutaneous Electrical Nerve Stimulation (TENS) procedure identical in setup and duration to the active TENS group. Electrodes will be placed in the same positions, and the current intensity will be increased for about 30 seconds until a strong but comfortable tingling is felt, then gradually reduced to 0 milliamperes (mA). The electrodes will remain in place for 20 minutes to mimic the active procedure. Neither participants nor evaluators will have visual access to the device display.
Participants will also receive a placebo needle intervention, consisting of a non-penetrating sham needle applied to the same anatomical region without skin insertion. This procedure mimics the sensation of needling but does not break the skin or produce physiological effects.
干预措施: Sham Transcutaneous Electrical Nerve Stimulation (Device)
Sham PENS
Participants will undergo a sham Percutaneous Electrical Nerve Stimulation (PENS) procedure. A real sterile acupuncture needle (0.30 × 50 millimeters (mm)) will be inserted at the same anatomical location used in the active PENS group, following the same ultrasound-guided procedure. The stimulator will remain switched off, following the same procedure used in the sham TENS group: the intensity will be increased for approximately 30 seconds until a comfortable tingling sensation is perceived and then gradually reduced to 0 milliamperes (mA), ensuring that no real stimulation is delivered.
The needle will remain in place for 20 minutes to mimic the duration and setup of the active treatment.
干预措施: Sham Percutaneous Electrical Nerve Stimulation (Device)
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: Baseline and immediately post-intervention
Description: It will be assessed as an indirect measure of the effect on the Aδ sensory fibers of the radial nerve. To record the mechanical pain threshold, a point will be marked on the dorsal surface of the trapeziometacarpal joint. A digital algometer with an increment scale of 0.1 Newtons (N) (Wagner Instruments, model FDIX) and a circular probe of 1 centimeter (cm) in diameter will be used. Once the probe is placed perpendicular to the skin, pressure will be increased at a rate of approximately 5 Newtons per second (N/s). Three measurements will be taken, with 15-second intervals between them, and the mean of the three values will be recorded as the pressure pain threshold. The reproducibility and reliability of pressure algometry to measure pressure pain threshold have been demonstrated in previous studies.
Thermal Pain Threshold
时间窗: Baseline and immediately post-intervention
Thermal pain threshold will be assessed as an indirect measure of the effect on unmyelinated C-type sensory fibers of the radial nerve. Hot stimuli will be applied to the dorsal area of the second metacarpal (radial nerve dermatome) using a 9 square centimeters (cm²) Peltier thermode (TSA 2, MEDOC, Israel). Three ascending temperature ramps will be performed with one-minute intervals. The heat pain threshold will be determined by the method of limits, and the average of the three measurements will be recorded. Baseline temperature: 32 degrees Celsius (°C); increase rate: 1 degree Celsius per second (°C/s); decrease rate: 3 °C/s. Participants will press a button with the contralateral hand when the heat becomes painful, triggering automatic cooling. For safety, a 50 °C cutoff temperature will be used. Prior to testing, a familiarization trial will be conducted on the dominant hand over the first and second metacarpals.
次要结局
- Maximal Isometric Wrist Extensor Strength(Baseline and immediately post-intervention)