An Investigation Into the Short-term Effects of Capacitive and Resistive Electrical Transfer Therapy Alone Versus Combined With Electrical Stimulation in Chronic Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 37
- 主要终点
- Pain intensity at rest
研究概览
简要总结
The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. The main questions it aims to answer are:
- Does adding Hi-EMS to TECAR therapy reduce low back pain at rest?
- Does adding Hi-EMS reduce pain during the Five-Times-Sit-to-Stand Test?
- Does adding Hi-EMS improve pressure pain threshold and performance on the - Five-Times-Sit-to-Stand Test?
Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS.
Participants will:
- Receive both treatment conditions in a randomized order
- Wait one week between treatment sessions
- Receive 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer during each session
- Receive Hi-EMS during the 10-minute resistive electrical transfer phase in one of the sessions
- Complete pain, pressure pain threshold, and functional performance assessments immediately before and after each session
详细描述
Capacitive and resistive electric transfer (TECAR) therapy is a radiofrequency-based electrothermal modality designed to generate endogenous tissue heating. Preliminary evidence suggests that TECAR therapy may provide short-term improvements in pain and disability in individuals with low back pain. Some TECAR devices also incorporate a manufacturer-specific electrical stimulation function known as high-intensity electromyostimulation (Hi-EMS). However, the additional effects of combining Hi-EMS with TECAR therapy have not been established.
This randomized, assessor-blinded crossover trial will investigate whether adding Hi-EMS to TECAR therapy produces greater immediate improvements in pain and functional performance than TECAR therapy alone in individuals with chronic nonspecific low back pain. Each participant will receive both treatment conditions in a randomized order, allowing participants to serve as their own controls. The treatment sessions will be separated by a one-week washout period.
The study will evaluate immediate within-session responses and compare the magnitude of change between the two treatment conditions. The findings will help determine whether the concurrent use of Hi-EMS provides additional short-term benefits beyond those produced by TECAR therapy alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 to 60 years old
- •chronic nonspecific low back pain
- •minimum pain intensity of 3 on a 0-10 scale
- •be able to provide consent and comply with study procedures
排除标准
- •spinal fracture
- •radiculopathy
- •neurological or vascular condition
- •pregnancy
- •cardiac pacemaker or other implanted device
- •skin disorder or allergy
- •altered sensation in the treatment area
- •active or recent hemorrhage
- •cognitive impairments
- •liniments or heat rubs immediately before a study session
- •treatment for low back within the previous 6 weeks
- •currently receiving disability benefits because of low back pain
- •current or pending litigation related to low back pain
研究组 & 干预措施
TECAR Therapy Plus Hi-EMS
Participants will receive TECAR therapy with concurrent Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer, with Hi-EMS delivered only during the 10-minute resistive electrical transfer phase.
干预措施: TECAR Therapy plus Hi-EMS (Device)
TECAR Therapy Alone
Participants will receive TECAR therapy without Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer.
干预措施: Tecar therapy alone (Device)
结局指标
主要结局
Pain intensity at rest
时间窗: Immediately before and immediately after each treatment session
Low back pain intensity at rest will be assessed using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate their current low back pain while at rest before performing the functional test. Higher scores indicate greater pain intensity.
Movement-Evoked Pain Intensity
时间窗: Immediately before and immediately after each treatment session.
Movement-evoked low back pain intensity will be assessed immediately after the Five-Times-Sit-to-Stand Test using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate the greatest low back pain experienced while performing the test. Higher scores indicate greater pain intensity.
次要结局
- Pressure pain threshold(Immediately before and immediately after each treatment session.)
- Five-Times-Sit-to-Stand Test(Immediately before and immediately after each treatment session.)
研究者
Richard Liebano
PhD
University of Hartford