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

Primary Purpose

Myofascial Pain Syndrome of Neck

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Surface electrical stimulation (SES)
Remote medical support
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring Myofascial Pain Syndromes, Surface electrical stimulation, Remote medical support, Telemedicine

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • WanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

SES combined with telemedical support

SES

No intervention

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Pain pressure threshold (kg/m2)
The pain pressure threshold is measured by using a hand-held dynamometer.
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.
Beck Anxiety Inventory (BAI, scoring from 0~63)
The BAI is a brief, self-report assessment for measuring anxiety severity and level.

Full Information

First Posted
July 25, 2023
Last Updated
August 4, 2023
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05972837
Brief Title
Effects of Home-based Surface Electrical Stimulation for Patients With Cervical Myofascial Pain Syndrome
Official Title
Effects of Home-based Surface Electrical Stimulation for Patients With Cervical Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck
Keywords
Myofascial Pain Syndromes, Surface electrical stimulation, Remote medical support, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SES combined with telemedical support
Arm Type
Experimental
Arm Description
SES device for personal use will be provided for participants in addition to remote medical support.
Arm Title
SES
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Surface electrical stimulation (SES)
Intervention Description
Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
Intervention Type
Other
Intervention Name(s)
Remote medical support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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 Outcome Measure Information:
Title
Pain intensity
Description
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
Title
Range of motion of the neck
Description
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
Title
Pain pressure threshold (kg/m2)
Description
The pain pressure threshold is measured by using a hand-held dynamometer.
Time Frame
8 weeks
Title
Neck disability index (NDI, 0~100%)
Description
The NDI is a questionnaire used for assessing self-rated disability in patient participant with neck pain of mechanical origin.
Time Frame
8 weeks
Title
Beck Anxiety Inventory (BAI, scoring from 0~63)
Description
The BAI is a brief, self-report assessment for measuring anxiety severity and level.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
WanFang Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin, MD, MS
Phone
+886970746879
Email
semitune@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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