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

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05972837
Collaborator
(none)
60
1
3
14.9
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Surface electrical stimulation (SES)
  • Other: Remote medical support
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Home-based Surface Electrical Stimulation for Patients With Cervical Myofascial Pain Syndrome
Actual Study Start Date :
Aug 4, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [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 Outcome Measures

  1. Pain intensity [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.

  2. Range of motion of the neck [8 weeks]

    The range of motion of the neck is measured by using motion capture system with the IMU (inertial measurement unit) sensors.

  3. Pain pressure threshold (kg/m2) [8 weeks]

    The pain pressure threshold is measured by using a hand-held dynamometer.

  4. Neck disability index (NDI, 0~100%) [8 weeks]

    The NDI is a questionnaire used for assessing self-rated disability in patient participant with neck pain of mechanical origin.

  5. Beck Anxiety Inventory (BAI, scoring from 0~63) [8 weeks]

    The BAI is a brief, self-report assessment for measuring anxiety severity and level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WanFang Hospital New Taipei City Taiwan

Sponsors and Collaborators

  • Taipei Medical University WanFang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yen-Nung Lin, Director of Physical Medicine and Rehabilitation, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT05972837
Other Study ID Numbers:
  • N202204099
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yen-Nung Lin, Director of Physical Medicine and Rehabilitation, Taipei Medical University WanFang Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2023