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

NCT ID: NCT05972837

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2025-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myofascial Pain Syndrome of Neck

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SES combined with telemedical support

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

Group Type EXPERIMENTAL

Surface electrical stimulation (SES)

Intervention Type DEVICE

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

Remote medical support

Intervention Type OTHER

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.

SES

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.

Group Type ACTIVE_COMPARATOR

Surface electrical stimulation (SES)

Intervention Type DEVICE

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

No intervention

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surface electrical stimulation (SES)

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WanFang Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yen-Nung Lin, MD, MS

Role: primary

+886970746879

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N202204099

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Thai Massage on EMG
NCT02067325 COMPLETED NA