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

Not Applicable

Recruiting

• Conditions: Myofascial Pain Syndrome of Neck

• Registration Number: NCT05972837
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-02
• Study Start: 2023-08-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-08-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pain pressure threshold (kg/m2)	8 weeks	The pain pressure threshold is measured by using a hand-held dynamometer.
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.
Beck Anxiety Inventory (BAI, scoring from 0~63)	8 weeks	The BAI is a brief, self-report assessment for measuring anxiety severity and level.
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.
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.

Trial Locations

Locations (1)

WanFang Hospital; 🇨🇳 New Taipei City, Taiwan