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

Taipei Medical University

Status: Enrolling

Conditions: Myofascial Pain Syndrome of Neck

Treatments: Device: Surface electrical stimulation (SES); Other: Remote medical support

Study type: Interventional

Funder types: Other

Identifiers

NCT05972837

N202204099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

SES combined with telemedical support

Experimental group

Description:

SES device for personal use will be provided for participants in addition to remote medical support.

Treatment:

Other: Remote medical support

Device: Surface electrical stimulation (SES)

SES

Active Comparator group

Description:

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.

Treatment:

Device: Surface electrical stimulation (SES)

No intervention

No Intervention group

Description:

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.