Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome
NCT ID: NCT05972837
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-04
2025-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SES combined with telemedical support
SES device for personal use will be provided for participants in addition to remote medical support.
Surface electrical stimulation (SES)
Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
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.
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.
Surface electrical stimulation (SES)
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.
No interventions assigned to this group
Interventions
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Surface electrical stimulation (SES)
Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
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.
Eligibility Criteria
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Inclusion Criteria
* Neck pain \> 2 months
* Diagnosis of cervical myofascial pain syndrome
* VAS pain ≥ 3 (0\~10)
Exclusion Criteria
* 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
20 Years
60 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Yen-Nung Lin
Director of Physical Medicine and Rehabilitation
Locations
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WanFang Hospital
New Taipei City, , Taiwan
Countries
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Facility Contacts
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Other Identifiers
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N202204099
Identifier Type: -
Identifier Source: org_study_id
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