The Effect of Frequency Modulation in Transcutaneous Electrical Nerve Stimulation (TENS) on Habituation and Pain Threshold: a Randomized, Double Blind, Controlled Cross-over
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Habituation to electrical stimulation
研究概览
简要总结
Purpose
The purpose of this study is to determine whether application of Transcutaneous Electrical Nerve Stimulation (TENS) is effective on habituation to electrical current whether delivered at a fixed frequency of 100 Hz or at patterned frequency. The secondary purposes are to determine the effectiveness on mechanical pressure pain and the subjective perception of the subjects regarding habituation and comfort of the different stimulations.
详细描述
Low frequency and low intensity TENS showed strong evidence of inefficiency while conventional high frequency TENS (around 100Hz) applied at "strong but comfortable" intensity proved strong evidence of efficacy on pressure pain. In addition, some studies have shown the importance of current intensity in the effect of TENS.
Either in clinical practice and in research, TENS intensity is usually adjusted according to the sensation of the subjects "strong but comfortable" "strong just below the motor threshold", ...). Usually throughout the TENS applications there is a phenomenon called "habituation" that involve a wide decrease of the sensation of the current applied, even though the perception the output-parameters are maintained.
In this sense, It has been seem that adjusting the intensity throughout the TENS intervention produced a greater hypoalgesic effect than when the intensity remained fixed.
On the other hand, most TENS devices offer the possibility of modulating current with the aim of preventing habituation phenomenon. The modulation of the electric current consists of changing the characteristics of the current (pulse width, pulse frequency, ...) every few seconds during the intervention. Nevertheless, the most common pattern used is the frequency modulation. However, there is a lack of evidence regarding what it is the better methods to avoid habituation during a TENS application.
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 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. Cancer. 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.
研究组 & 干预措施
TENS: Fixed frequency
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
干预措施: TENS: Fixed frequency (Device)
TENS: Randomized frequency modulation
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
干预措施: TENS: Randomized frequency modulation (Device)
TENS: Scan 6/6 of frequency modulation
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
干预措施: TENS: Scan 6/6 of frequency modulation (Device)
TENS: Sham stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Habituation to electrical stimulation
时间窗: at 10 min. post-treatment
Due to habituation it is necessary to increase the intensity of the current throughout the session. Two measures were recorded within this variable: i) the increase in current density (mA / cm2) throughout the session (difference between its initial frequency and final frequency value of the current) and the number of times the participant requested to increase the intensity (subjects were instructed to maintain the same threshold)
次要结局
- Perception current comfortability(at 1min. post-treatment)
- Mechanical pain threshold(at 10 min. post-treatment)
- Perception current habituation(at 1min. post-treatment)