NCT05972837

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

July 25, 2023

Last Update Submit

January 15, 2025

Conditions

Myofascial Pain Syndrome of Neck

Keywords

Myofascial Pain SyndromesSurface electrical stimulationRemote medical supportTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (5)

  • Pain intensity

    8 weeks

  • Range of motion of the neck

    8 weeks

  • Pain pressure threshold (kg/m2)

    8 weeks

  • Neck disability index (NDI, 0~100%)

    8 weeks

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

    8 weeks

Study Arms (3)

SES combined with telemedical support

EXPERIMENTAL

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

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.

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.

Interventions

Surface electrical stimulation (SES)DEVICE

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

SESSES combined with telemedical support
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.

SES combined with telemedical support

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Time of using computer \> 4hrs/day
  • Neck pain \> 2 months
  • Diagnosis of cervical myofascial pain syndrome
  • VAS pain ≥ 3 (0\~10)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

August 4, 2023

Primary Completion

August 1, 2025

Study Completion

November 1, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)