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

Taipei Medical University WanFang Hospital60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myofascial Pain Syndrome of Neck

Interventions

Surface electrical stimulation (SES)DEVICE

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

Remote medical supportOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

WanFang Hospital

New Taipei City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks

Pain pressure threshold (kg/m2)

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

Time frame: 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.

Time frame: 8 weeks

Beck Anxiety Inventory (BAI, scoring from 0~63)

The BAI is a brief, self-report assessment for measuring anxiety severity and level.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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