Effects of Electrical Muscle Stimulation on Myofascial Pain Syndrome

NCT ID: NCT07315776

Last Updated: 2026-01-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2025-09-20

Brief Summary

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The goal of this clinical trial is to determine if Electrical Muscle Stimulation (EMS) combined with Active Stretching (AS) (EMS+AS) and EMS+AS combined with Trigger Point Pressure Release (TPR) (EMS+AS+TPR) are effective treatments for Myofascial Pain Syndrome (MPS) in working adults. The study will also assess the safety of the EMS+AS intervention. The main questions it aims to answer are: Do EMS+AS and EMS+AS+TPR lead to greater pain reduction, increased pressure pain threshold, and improved surface electromyography (sEMG) activity when compared to standard treatments? Furthermore, what is the participant feedback regarding EMS+AS and other treatments?

Researchers will compare EMS+AS to passive stretching (PS) and TPR to see if EMS+AS and EMS+AS+TPR are effective in treating myofascial trigger points in the trapezius muscle.

Participants will receive seven interventions across a single visit, including PS, EMS+AS, TPR, TPR combined with AS (TPR+AS), EMS+AS+TPR, Sham stimulation, and Transcutaneous Electrical Nerve Stimulation (TENS). Each treatment will consist of three 10-second sets with a 10-second rest between sets, and a 2-minute break provided between different treatments. Participants will have measurements taken on changes in pain intensity, pressure pain threshold, and sEMG activity during trapezius action pre- and post-treatment. Additionally, participants will report personal information, previous MPS treatments, and baseline health status, and provide feedback on satisfaction, treatment preferences, exercise knowledge for MPS prevention, and qualitative comments. For supplementary data, we selected only the EMS+AS and TPR interventions with the same protocol to evaluate changes in range of motion and changes in trigger point size and trapezius thickness (both at rest and during stretching) via ultrasound imaging.

Detailed Description

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The main study measures included changes in pain intensity, pressure pain threshold, and sEMG activity. The supplementary study measures included ultrasound images and range of motion.

Conditions

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Myofascial Pain Syndrome (MPS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Treatments were administered in a computer-generated randomised order, concealed from participants.The principal researcher collected all anonymous data for blinded analysis.

Study Groups

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Therapist-assisted Passive stretching (PS)

Passive Stretching with Therapist Assistance: The protocol consisted of three sets of stretching. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type ACTIVE_COMPARATOR

Therapist-assisted Passive stretching (PS)

Intervention Type OTHER

The therapist stretched the upper trapezius muscle via shoulder depression and neck deviation. The middle trapezius muscle was stretched using scapular protraction while simultaneously stabilizing the mid-spine and gently pulling the arm inward.

The two-combination of EMS+AS

Electrical Muscle Stimulation (EMS) combined with Active Stretching (AS) was applied to the upper or middle trapezius muscle to facilitate muscle elongation. The protocol consisted of three sets of performing. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type EXPERIMENTAL

The two-combination of EMS+AS

Intervention Type OTHER

Electrical Muscle Stimulation combined with Active Stretching: The EMS component utilized parameters of 20 Hz frequency and 100 µs pulse width, with the amplitude adjusted individually for intensity. The EMS electrodes were placed across the muscle fibers with a 1 cm inter-electrode distance. This placement was specifically designed to restrict the electrical field, thereby inducing a local muscle contraction that opposes the direction of the active stretch being performed concurrently.

Trigger point pressure release (TPR)

Trigger Point Pressure Release (TPR): TPR was directly applied to the MTP of upper or middle trapezius muscle.The protocol consisted of three sets of performing. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type ACTIVE_COMPARATOR

Trigger point pressure release (TPR)

Intervention Type OTHER

Trigger point Pressure Release (TPR): The therapist utilized a PAIN TEST™ FPX series pressure gauge (Wagner Instruments). A round rubber 1 cm2 force gauge probe was applied directly on the MTP by gradually increasing the pressure until the participant reached their maximum pressure tolerance level.

Trigger point pressure release combined with active stretching (TPR+AS)

Trigger Point Pressure Release (TPR) combined with Active Stretching (AS) was performed either by using neck deviation for the upper trapezius muscle or by using scapula protraction for the middle trapezius muscle during TPR. The protocol consisted of three sets of performing. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type OTHER

Trigger point pressure release combined with active stretching (TPR+AS)

Intervention Type OTHER

Trigger point Pressure Release combined with Active Stretching (TPR+AS) was performed by applying active stretching of the trapezius muscle concurrently with TPR, using the same protocol as the standalone TPR intervention.

The triple combination therapy of EMS+AS+TPR

This triple combination therapy was applied to enhance MTP release in the upper or middle trapezius muscles. The protocol consisted of three sets of performing. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type EXPERIMENTAL

The triple combination therapy of EMS+AS+TPR

Intervention Type OTHER

Electrical Muscle Stimulation combined with Active Stretching during Trigger point Pressure Release (EMS+AS+TPR): This triple combination therapy utilized the EMS+AS component protocol concurrently with the TPR intervention, applying the identical protocols established for the standalone EMS+AS and TPR procedures.

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous Electrical Nerve Stimulation (TENS) was applied on the upper or middle trapezius muscles without stretching. The protocol consisted of three sets of operating. Each set was performed for 10 seconds and followed by a 10-second break, totaling one minute for the single session.

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type OTHER

Transcutaneous Electrical Nerve Stimulation (TENS) was applied using the conventional protocol (60 Hz,100 µs,5 mA) with two electrodes placed directly over the MTP region, without stretching.

Sham stimulation combined with active stretching (SS+AS)

SS+AS consisted only of active stretching of the upper or middle trapezius muscle, with no electrical current applied from EMS device. Self-stretching was performed for three sets, with each 10-second stretch followed by a 10-second break, resulting in a total session time of one minute.

Group Type SHAM_COMPARATOR

Sham stimulation combined with active stretching (SS+AS)

Intervention Type OTHER

Sham stimulation combined with active stretching (SS+AS): Participants performed AS using the same EMS device and electrode placement as in the EMS+AS protocol. However, no electrical current was applied. The procedure began with a conversation about the treatment from the researcher while the current amplitude was reduced from 1 mA to 0 mA during the trapezius muscle stretching, accompanied by a beeping sound to simulate stimulation. Participants were subsequently informed that this was the intended treatment.

Interventions

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Therapist-assisted Passive stretching (PS)

The therapist stretched the upper trapezius muscle via shoulder depression and neck deviation. The middle trapezius muscle was stretched using scapular protraction while simultaneously stabilizing the mid-spine and gently pulling the arm inward.

Intervention Type OTHER

The two-combination of EMS+AS

Electrical Muscle Stimulation combined with Active Stretching: The EMS component utilized parameters of 20 Hz frequency and 100 µs pulse width, with the amplitude adjusted individually for intensity. The EMS electrodes were placed across the muscle fibers with a 1 cm inter-electrode distance. This placement was specifically designed to restrict the electrical field, thereby inducing a local muscle contraction that opposes the direction of the active stretch being performed concurrently.

Intervention Type OTHER

Trigger point pressure release (TPR)

Trigger point Pressure Release (TPR): The therapist utilized a PAIN TEST™ FPX series pressure gauge (Wagner Instruments). A round rubber 1 cm2 force gauge probe was applied directly on the MTP by gradually increasing the pressure until the participant reached their maximum pressure tolerance level.

Intervention Type OTHER

Trigger point pressure release combined with active stretching (TPR+AS)

Trigger point Pressure Release combined with Active Stretching (TPR+AS) was performed by applying active stretching of the trapezius muscle concurrently with TPR, using the same protocol as the standalone TPR intervention.

Intervention Type OTHER

The triple combination therapy of EMS+AS+TPR

Electrical Muscle Stimulation combined with Active Stretching during Trigger point Pressure Release (EMS+AS+TPR): This triple combination therapy utilized the EMS+AS component protocol concurrently with the TPR intervention, applying the identical protocols established for the standalone EMS+AS and TPR procedures.

Intervention Type OTHER

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous Electrical Nerve Stimulation (TENS) was applied using the conventional protocol (60 Hz,100 µs,5 mA) with two electrodes placed directly over the MTP region, without stretching.

Intervention Type OTHER

Sham stimulation combined with active stretching (SS+AS)

Sham stimulation combined with active stretching (SS+AS): Participants performed AS using the same EMS device and electrode placement as in the EMS+AS protocol. However, no electrical current was applied. The procedure began with a conversation about the treatment from the researcher while the current amplitude was reduced from 1 mA to 0 mA during the trapezius muscle stretching, accompanied by a beeping sound to simulate stimulation. Participants were subsequently informed that this was the intended treatment.

Intervention Type OTHER

Other Intervention Names

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PS EMS+AS TPR TPR+AS EMS+AS+TPR TENS SS+AS

Eligibility Criteria

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Inclusion Criteria

* Participants over 18 years old with either active or latent myofascial trigger points in the trapezius muscle were diagnosed with MPS by a General Practitioner (GP).
* Participants have no history of chronic diseases (cancer, cervical nerve root compression, heart arrhythmias, including hyperthyroid, muscle weakness, seizure, skin infection at the upper back, spinal cord injury, stroke).
* Participants have ability to move the upper limbs.
* Participants reported no use of pacemakers or strong pain relievers, no allergies to metals, gels, or cleaning products, and no pre-existing severe muscle soreness.

Exclusion Criteria

* Participants less 18 years old with no myofascial trigger points in the trapezius muscle.
* Participants to have history of chronic diseases (cancer, cervical nerve root compression, heart arrhythmias, including hyperthyroid, muscle weakness, seizure, skin infection at the upper back, spinal cord injury, stroke).
* Participants cannot move the upper limbs.
* Participants reported use of pacemakers or strong pain relievers, and allergies to metals, gels, or cleaning products, and pre-existing severe muscle soreness.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suranaree University of Technology

OTHER

Sponsor Role collaborator

University of Bath

OTHER

Sponsor Role lead

Responsible Party

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SEEKAOW CHURPROONG

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SEEKAOW CHURPROONG, MD.

Role: PRINCIPAL_INVESTIGATOR

University of Bath, United Kingdom.

Locations

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Department of Electronic and Electrical Engineering

Bath, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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4961-6056

Identifier Type: OTHER

Identifier Source: secondary_id

EP 22 081

Identifier Type: -

Identifier Source: org_study_id

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