跳至主要内容
临床试验/NCT06559358
NCT06559358尚未招募不适用

Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain

Beni-Suef University0 个研究点目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Pressure threshold

研究概览

简要总结

this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 40 to 65 years old participated in this study, 2
  • •Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
  • •Having one or more trigger points in the upper trapezius muscle,
  • •A significant increase in neck muscle EMG activity indicates the presence of tender points.

排除标准

  • •Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
  • •Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
  • •Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities

研究组 & 干预措施

Group 1

Experimental

This group will receive subthreshold stimulation

干预措施: electrical stimulation (Device)

Group 2

Experimental

This group will receive suprathreshold stimulation

干预措施: electrical stimulation (Device)

Group 3

Sham Comparator

This group will receive no stimulation

干预措施: electrical stimulation (Device)

结局指标

主要结局

Pressure threshold

时间窗: 2-3 months

Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle.

Pain intensity

时间窗: 2-3 months

Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain"

Electromyography

时间窗: 2-3 months

The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.

Range of motion

时间窗: 2-3 months

Flexion, lateral rotation to both sides, lateral flexion to both sides

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Mohamed

Associate Lecturer

Beni-Suef University

相似试验