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临床试验/NCT05972837
NCT05972837招募中不适用

Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

The aim of this study is to compare the developed home-based surface electrical stimulation program to the controls in computer office workers with MPS.

详细描述

Cervical myofascial pain syndrome (MPS) is a common problem among workers who have large amount of computer use. Additionally, owing to the high workload and long hours of staying in thier cubicle, the office employees are often unable to have extra time to receive rehabilitation and treatment regularly. A home-based surface electrical stimulation (SES) program is developed to help intervention be time-saving and more accessible for office-based staff busy at work.

In this single-blind randomized controlled trial, participants will be assigned to one of the following three groups and undergo 3 weeks (20 minutes/ time, three times/ week) of intervention:

  1. SES combined with telemedical support
  2. SES
  3. No intervention

The outcome assessments will be performed before and after the intervention (0-wk and 4-wk) and 4 weeks after the endpoint of intervention (8-wk). The outcome assessor was blind to the intervention and group allocation.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Time of using computer > 4hrs/day
  • Neck pain > 2 months
  • Diagnosis of cervical myofascial pain syndrome
  • VAS pain ≥ 3 (0~10)

排除标准

  • Had a history of neck surgery
  • Pregnancy
  • Systematic disease (e.g. autoimmune disorders, arthritis, infection, etc.)
  • Malignancy
  • Neurological signs such as radiating pain, motor weakness in the upper extremities.
  • Skin defect or scars at the planned placement of SES
  • Pacemaker user
  • History of seizure attack
  • History of diabetes
  • Fear of receiving SES

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

A visual analog scale (VAS, scoring from 0-10) is used to measure a participant's pain intensity. The participant indicates their level of pain on average over the past 3 days.

次要结局

  • Pain pressure threshold (kg/m2)(8 weeks)
  • Neck disability index (NDI, 0~100%)(8 weeks)
  • Beck Anxiety Inventory (BAI, scoring from 0~63)(8 weeks)
  • Pain intensity(8 weeks)
  • Range of motion of the neck(8 weeks)

研究者

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

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Taipei Medical University WanFang Hospital

研究点 (1)

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