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

August 4, 2023 updated by: Yen-Nung Lin, Taipei Medical University WanFang Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • WanFang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SES combined with telemedical support
SES device for personal use will be provided for participants in addition to remote medical support.
Device: Surface electrical stimulation (SES)
Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
Other: Remote medical support
The remote medical support includes a session of video call with a rehabilitation doctor in the first week and weekly telehealth visits with a live physical therapist or physician. The contents of the video calls contain patient education, stretching exercises teaching and instructions of using SES for MPS.
Active Comparator: SES
Participants in this group will also attend an appointment via a video call with a rehabilitation doctor in the first week but no weekly telehealth visits. Only SES device for personal use and a user manual will be provided.
Device: Surface electrical stimulation (SES)
Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
No Intervention: No intervention
Participants in this group will not be provided either SES device or weekly telehealth visits. They are only required to attend a session of video call with a rehabilitation doctor in the first week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 8 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 and at its worst during work or at rest over the past 3 days.
8 weeks
Range of motion of the neck
Time Frame: 8 weeks
The range of motion of the neck is measured by using motion capture system with the IMU (inertial measurement unit) sensors.
8 weeks
Pain pressure threshold (kg/m2)
Time Frame: 8 weeks
The pain pressure threshold is measured by using a hand-held dynamometer.
8 weeks
Neck disability index (NDI, 0~100%)
Time Frame: 8 weeks
The NDI is a questionnaire used for assessing self-rated disability in patient participant with neck pain of mechanical origin.
8 weeks
Beck Anxiety Inventory (BAI, scoring from 0~63)
Time Frame: 8 weeks
The BAI is a brief, self-report assessment for measuring anxiety severity and level.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202204099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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