Effects of Electrical Muscle Stimulation on Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Changes in pressure pain threshold
研究概览
简要总结
The goal of this clinical trial is to determine if Electrical Muscle Stimulation (EMS) combined with Active Stretching (AS) (EMS+AS) and EMS+AS combined with Trigger Point Pressure Release (TPR) (EMS+AS+TPR) are effective treatments for Myofascial Pain Syndrome (MPS) in working adults. The study will also assess the safety of the EMS+AS intervention. The main questions it aims to answer are: Do EMS+AS and EMS+AS+TPR lead to greater pain reduction, increased pressure pain threshold, and improved surface electromyography (sEMG) activity when compared to standard treatments? Furthermore, what is the participant feedback regarding EMS+AS and other treatments?
Researchers will compare EMS+AS to passive stretching (PS) and TPR to see if EMS+AS and EMS+AS+TPR are effective in treating myofascial trigger points in the trapezius muscle.
Participants will receive seven interventions across a single visit, including PS, EMS+AS, TPR, TPR combined with AS (TPR+AS), EMS+AS+TPR, Sham stimulation, and Transcutaneous Electrical Nerve Stimulation (TENS). Each treatment will consist of three 10-second sets with a 10-second rest between sets, and a 2-minute break provided between different treatments. Participants will have measurements taken on changes in pain intensity, pressure pain threshold, and sEMG activity during trapezius action pre- and post-treatment. Additionally, participants will report personal information, previous MPS treatments, and baseline health status, and provide feedback on satisfaction, treatment preferences, exercise knowledge for MPS prevention, and qualitative comments. For supplementary data, we selected only the EMS+AS and TPR interventions with the same protocol to evaluate changes in range of motion and changes in trigger point size and trapezius thickness (both at rest and during stretching) via ultrasound imaging.
详细描述
The main study measures included changes in pain intensity, pressure pain threshold, and sEMG activity. The supplementary study measures included ultrasound images and range of motion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Treatments were administered in a computer-generated randomised order, concealed from participants.The principal researcher collected all anonymous data for blinded analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants over 18 years old with either active or latent myofascial trigger points in the trapezius muscle were diagnosed with MPS by a General Practitioner (GP).
- •Participants have no history of chronic diseases (cancer, cervical nerve root compression, heart arrhythmias, including hyperthyroid, muscle weakness, seizure, skin infection at the upper back, spinal cord injury, stroke).
- •Participants have ability to move the upper limbs.
- •Participants reported no use of pacemakers or strong pain relievers, no allergies to metals, gels, or cleaning products, and no pre-existing severe muscle soreness.
排除标准
- •Participants less 18 years old with no myofascial trigger points in the trapezius muscle.
- •Participants to have history of chronic diseases (cancer, cervical nerve root compression, heart arrhythmias, including hyperthyroid, muscle weakness, seizure, skin infection at the upper back, spinal cord injury, stroke).
- •Participants cannot move the upper limbs.
- •Participants reported use of pacemakers or strong pain relievers, and allergies to metals, gels, or cleaning products, and pre-existing severe muscle soreness.
结局指标
主要结局
Changes in pressure pain threshold
时间窗: Baseline and Day 1 (immediately post-intervention)
Changes in pressure pain threshold between before and after treatment were measured using a digital algometer (Wagner, Greenwich, USA). Pressure pain threshold was measured in kilogram force (kgf) or kilograms per square centimeter (kg/cm²). An increased score indicates a better outcome.
Changes in median frequency of EMG activity
时间窗: Baseline and Day 1 (immediately post-intervention)
Changes in the median frequency of surface electromyography (EMG) before and after treatment were recorded in hertz (Hz) using a 16-channel sEMG (Delsys Trigno Maize Sensor system). Changes in median frequency reflect physiological changes in muscle function. An increase in median frequency during trapezius muscle activity indicates physiological improvement.
Changes in Pain intensity
时间窗: Baseline and Day 1 (immediately post-intervention)
Changes in pain intensity before and after treatment were measured using a numeric rating scale (0-10), where 0 represents no pain and 10 represents the worst possible pain. A reduced score indicates a better outcome.
% maximum volunatary contraction (MVC) improvement
时间窗: Baseline and Day 1 (immediately post-intervention)
%MVC improvement of EMG activity before and after treatment was recorded in percent (%) after calculating the root mean square normalized to pre-treatment values using a 16-channel sEMG (Delsys Trigno Maize Sensor system). An increase in %MVC during trapezius muscle activity indicates muscle function improvement.
次要结局
- Changes in myofascial trigger point (MTP) size(Baseline and Day 1 (immediately post-intervention))
- Changes in range of motion (ROM) of neck deviation(Baseline and Day 1 (immediately post-intervention))
- Changes in trapezius muscle thickness(Baseline and Day 1 (immediately post-intervention))
- Changes in echointensiy at the myofascial trigger point (MTP)(Baseline and Day 1 (immediately post-intervention))
研究者
SEEKAOW CHURPROONG
Principal Investigator
University of Bath