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Recruiting NCT05972837

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

No phase Interventional Myofascial Pain Syndrome of Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surface electrical stimulation (SES), Remote medical support.
Who it may be relevant to
Registry conditions: Myofascial Pain Syndrome of Neck. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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:

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.

Interventions

  • Device Surface electrical stimulation (SES)
    Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
  • Other 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.

Primary outcome measures

  • Pain intensity [Time frame: 4 weeks]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • WanFang Hospital — New Taipei City

Identifiers

NCT: NCT05972837 · N202204099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗