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NCT Number: NCT05972837

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

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.

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Key information

Conditions

Myofascial Pain Syndrome of Neck Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • SES combined with telemedical support
  • SES
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surface electrical stimulation (SES)

Device

Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.

Remote medical support

Other

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. Pain pressure threshold (kg/m2)

    Time frame: 8 weeks

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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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