Myofascial Pain Syndrome of NeckNCT05972837
Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome
A study testing Surface electrical stimulation (SES) and Remote medical support in people with Myofascial Pain Syndrome of Neck, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Myofascial Pain Syndrome of Neck
- What is being tested?
- Surface electrical stimulation (SES) and Remote medical support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Time of using computer > 4hrs/day
- Neck pain > 2 months
- Diagnosis of cervical myofascial pain syndrome
- VAS pain ≥ 3 (0~10)
Who cannot join
- 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
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- Pacemaker user
- History of seizure attack
- History of diabetes
- Fear of receiving SES
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Hospital
New Taipei City
Yen-Nung Lin, MD, MS, +886970746879, semitune@gmail.com
About this study
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.
Read the detailed 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:
- SES combined with telemedical support
- SES
- 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
- Myofascial Pain Syndrome of Neck
- Being tested
- Surface electrical stimulation (SES), Remote medical support
- Keywords
- Myofascial Pain Syndromes, Surface electrical stimulation, Remote medical support, Telemedicine
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SES combined with telemedical support | Experimental | SES device for personal use will be provided for participants in addition to remote medical support. Receives: Device: Surface electrical stimulation (SES); Other: Remote medical support |
| SES | Active comparator | 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. Receives: Device: Surface electrical stimulation (SES) |
| No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 8 weeks
Pain pressure threshold (kg/m2)
The pain pressure threshold is measured by using a hand-held dynamometer.
Measured: 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.
Measured: 8 weeks
Beck Anxiety Inventory (BAI, scoring from 0~63)
The BAI is a brief, self-report assessment for measuring anxiety severity and level.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start4 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome of NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972837
- Sponsor's protocol ID
- N202204099
- Status last verified
- Jan 2025
- First submitted
- 25 Jul 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05972837
- Acronym / sponsor ID
- N202204099
- Conditions
- Myofascial Pain Syndrome of Neck
- Keywords
- Myofascial Pain Syndromes, Surface electrical stimulation, Remote medical support, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- SES combined with telemedical support
- SES
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SES combined with telemedical support | Experimental | Device: Surface electrical stimulation (SES), Other: Remote medical supportSES device for personal use will be provided for participants in addition to remote medical support. |
| SES | Active comparator | Device: Surface electrical stimulation (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. |
| No 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Time of using computer > 4hrs/day
- Neck pain > 2 months
- Diagnosis of cervical myofascial pain syndrome
- VAS pain ≥ 3 (0~10)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface electrical stimulation (SES)Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention. | Device | SES, SES combined with telemedical support |
| Remote medical supportThe 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. | Other | SES combined with telemedical support |
Primary outcome
Pain intensity
Time frame: 4 weeks
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.
5 secondary outcomes
Pain intensity
Time frame: 8 weeks
Range of motion of the neck
Time frame: 8 weeks
Pain pressure threshold (kg/m2)
Time frame: 8 weeks
Neck disability index (NDI, 0~100%)
Time frame: 8 weeks
Beck Anxiety Inventory (BAI, scoring from 0~63)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface electrical stimulation (SES) and Remote medical support in people with Myofascial Pain Syndrome of Neck, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.