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Clinical Trials/NCT05972837
NCT05972837
Recruiting
Not Applicable

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

Taipei Medical University WanFang Hospital1 site in 1 country60 target enrollmentAugust 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myofascial Pain Syndrome of Neck
Sponsor
Taipei Medical University WanFang Hospital
Enrollment
60
Locations
1
Primary Endpoint
Pain intensity
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 4, 2023
End Date
November 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Taipei Medical University WanFang Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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