跳至主要内容
临床试验/NCT06604962
NCT06604962已完成不适用

Intramuscular Electrical Stimulation Using Inverse Electrodes Placement on Electromyographic Activity and Pressure Pain Threshold in the Upper Trapezius With Trigger Points - A Randomized Controlled Trial

Gulf Medical University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Pressure pain threshold (PPT)

研究概览

简要总结

The prevalence of myofascial pain ranges from 30 to 93% and can result in sensorimotor and autonomic deficits. In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) and inverse electrode placement (IEP) are used to deliver electrical stimulation for pain modulation. However, Whether pain modulation can be achieved better from the intramuscular electrical stimulation (IMES) using the inverse electrode placement (IEP) or the conventional electrode placement (CEP) is still an open issue. Thus, current study's aim to compare the effects of IMES using IEP and CEP, and sham-IMES on pressure pain threshold (PPT), EMG activity, upper trapezius (UT) muscle length and pain severity in the UT muscle with myofascial trigger points (MTrPs) among young adults.

详细描述

Myofascial trigger points (MTrPs) are defined as discrete areas of tenderness in taut bands of skeletal muscles that are painful. The upper trapezius (UT) muscle has been found to be often affected by MTrPs, which can result in altered sensory-motor function.

MTrPs may be related to pressure pain sensitivity and alterations in the upper trapezius muscle activity. A reduction in PPTs and increased electromyographic (EMG) activity of the UT muscle with MTrPs can be respectively interpreted as increased pain receptors sensitization and motor endplate activity.

In routine clinical practice, exercises, TrP injections, medications, and alternative therapies such as acupuncture dry needling (DN) are used to treat MTrPs. In recent years, some studies have reported that intramuscularly delivered electrical stimulation is a potential resource for the management of myofascial pain syndrome (MPS). Evidence from the literature suggests that IMES is effective in conditions such as adhesive capsulitis, MPS, and other non-traumatic musculoskeletal disorders.

In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) is used, in which an active cathode pole is placed in the peripheral target tissue and a reference anode is placed over the spinal level for peripheral pain modulation. Inverse electrode placement (IEP) is a alternate electrode placement method in which a cathode pole is placed over the spinal level and an anode pole over the distal parts of the limbs. IEP model experiments on MPS and non-traumatic shoulder pain disorders achieved significant clinical outcomes for shoulder pain and associated functional disabilities.

Although IMES is effective in reducing the pain threshold and changing EMG activity, the difference between the effects of IMES based on IEP and CEP on PPT and EMG activity (%MVIC) remains unknown. In line with previous study findings, this study hypothesized that IMES using IEP would achieve significant changes in the PPT, EMG activity, muscle length, and pain severity of the UT muscle with TrPs compared with IMES using CEP and Sham-IMES

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Each random number concealed within the small opaque envelope, later all numbers concealed within the large opaque envelope. An independent researcher who was not part of the study generated 36 random (computer generated) numbers, and an office clerk was involved in the allotment of the specified interventions. The intervention provider, outcome assessors and statistician are blinded to interventions.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of myofascial trigger points in the upper trapezius (UT) muscle.
  • Pressure pain threshold range between 0.5 to 1.5 kg/cm2

排除标准

  • Shoulder conditions such as adhesive capsulitis, impingement syndrome, etc.
  • Individuals with cervical radiculopathy,
  • Nutritional deficiencies,
  • Metabolic disorders such as obesity, diabetes mellitus,
  • Participation in strength training,
  • Cardiac pacemakers,
  • History of migraine, epilepsy, electrophobia, needle phobia, skin diseases.

结局指标

主要结局

Pressure pain threshold (PPT)

时间窗: Day one before the treatment, day one post treatment and day three follow-up

Pressure algometry, a device that applies an increasing force over a limited constant surface, allows the quantification of the minimum pressure, which induces pain or discomfort, indicated as the PPT. PPT in the UT muscle area was assessed using a pressure algometer (JTECH Medical Commander Echo-Algometer with Console, Serial No-0d219167) by an experienced physiotherapist blinded to the intervention groups

Upper trapezius' Surface Electromyographic activity

时间窗: Day one before the treatment, day one post treatment and day three follow-up

The surface Electromyography (EMG) recording during the experimental condition and Maximum Voluntary Isometric Contraction (MVIC) of the UT muscle was performed using a BTS FREEEMG 1000 system (BTS Bioengineering, Milan, Italy) in three sessions: day one before and after treatment and day three follow-up. EMG data collected during the MVIC of the right-side UT muscle was used as a reference value to normalize the EMG activity of the experimental condition.

次要结局

  • Pain severity(Day one before the treatment, day one post treatment and day three follow-up)
  • Upper trapezius' muscle length(Day one before the treatment, day one post treatment and day three follow-up)

研究者

发起方
Gulf Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Intramuscular Electrical Stimulation on Upper... | 临床试验