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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myofascial Pain Syndrome of Neck

Intervention / Treatment
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* Device: Surface electrical stimulation (SES)
* Other: Remote medical support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SES combined with telemedical support<br>SES device for personal use will be provided for participants in addition to remote medical support. | Device: Surface electrical stimulation (SES)<br>* Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.<br>Other: Remote medical support<br>* 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.<br>|
| Active Comparator: SES<br>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)<br>* Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.<br>|
| No Intervention: No intervention<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 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 | 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 | 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) | The pain pressure threshold is measured by using a hand-held dynamometer. | 8 weeks | 
| Neck disability index (NDI, 0 100%) | 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) | The BAI is a brief, self-report assessment for measuring anxiety severity and level. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndromes, Surface electrical stimulation, Remote medical support, Telemedicine