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

Myofascial Pain Syndrome of Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972837
• Other study ID #: N202204099
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: August 2023
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome of Neck
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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