Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points

September 29, 2024 updated by: Gulf Medical University

Intramuscular Electrical Stimulation Using Inverse Electrodes Placement on Electromyographic Activity and Pressure Pain Threshold in the Upper Trapezius With Trigger Points - A Randomized Controlled Trial

The prevalence of myofascial pain ranges from 30 to 93% and can result in sensorimotor and autonomic deficits. In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) and inverse electrode placement (IEP) are used to deliver electrical stimulation for pain modulation. However, Whether pain modulation can be achieved better from the intramuscular electrical stimulation (IMES) using the inverse electrode placement (IEP) or the conventional electrode placement (CEP) is still an open issue. Thus, current study's aim to compare the effects of IMES using IEP and CEP, and sham-IMES on pressure pain threshold (PPT), EMG activity, upper trapezius (UT) muscle length and pain severity in the UT muscle with myofascial trigger points (MTrPs) among young adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myofascial trigger points (MTrPs) are defined as discrete areas of tenderness in taut bands of skeletal muscles that are painful. The upper trapezius (UT) muscle has been found to be often affected by MTrPs, which can result in altered sensory-motor function.

MTrPs may be related to pressure pain sensitivity and alterations in the upper trapezius muscle activity. A reduction in PPTs and increased electromyographic (EMG) activity of the UT muscle with MTrPs can be respectively interpreted as increased pain receptors sensitization and motor endplate activity.

In routine clinical practice, exercises, TrP injections, medications, and alternative therapies such as acupuncture dry needling (DN) are used to treat MTrPs. In recent years, some studies have reported that intramuscularly delivered electrical stimulation is a potential resource for the management of myofascial pain syndrome (MPS). Evidence from the literature suggests that IMES is effective in conditions such as adhesive capsulitis, MPS, and other non-traumatic musculoskeletal disorders.

In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) is used, in which an active cathode pole is placed in the peripheral target tissue and a reference anode is placed over the spinal level for peripheral pain modulation. Inverse electrode placement (IEP) is a alternate electrode placement method in which a cathode pole is placed over the spinal level and an anode pole over the distal parts of the limbs. IEP model experiments on MPS and non-traumatic shoulder pain disorders achieved significant clinical outcomes for shoulder pain and associated functional disabilities.

Although IMES is effective in reducing the pain threshold and changing EMG activity, the difference between the effects of IMES based on IEP and CEP on PPT and EMG activity (%MVIC) remains unknown. In line with previous study findings, this study hypothesized that IMES using IEP would achieve significant changes in the PPT, EMG activity, muscle length, and pain severity of the UT muscle with TrPs compared with IMES using CEP and Sham-IMES

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Clinical diagnosis of myofascial trigger points in the upper trapezius (UT) muscle.
  • Pressure pain threshold range between 0.5 to 1.5 kg/cm2

Exclusion Criteria:

  • Shoulder conditions such as adhesive capsulitis, impingement syndrome, etc.
  • Individuals with cervical radiculopathy,
  • Nutritional deficiencies,
  • Metabolic disorders such as obesity, diabetes mellitus,
  • Participation in strength training,
  • Cardiac pacemakers,
  • History of migraine, epilepsy, electrophobia, needle phobia, skin diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: IMES using IEP
Participants in this group has allocated to the Intramuscular electrical stimulation using inverse electrode placement
Procedure: IMES using IEP
First group (n=12) received IMES using inverse electrode placement. The needle electrode inserted into the paraspinal region was connected to the active or cathode pole of the electrical stimulator. The reference or anode pole of the electrical stimulator was connected to the electrode that was inserted into the MTrP area of the UT muscle. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation
Active Comparator: Group II: IMES using CEP
Participants in this group has allocated to the Intramuscular electrical stimulation using conventional electrode placement
Procedure: IMES using CEP
Second group (n=12) underwent IMES with conventional electrode placement. In this group, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. Needle electrodes were connected using alligator clip connectors. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation.
Sham Comparator: Group III: Sham-IMES
Participants in this group has allocated to the Sham Intramuscular electrical stimulation
Other: Sham-IMES
Third group (n=12) received sham-IMES. Similar to the experimental intervention groups, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. However, the delivered IMES was very minimal intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold (PPT)
Time Frame: Day one before the treatment, day one post treatment and day three follow-up
Pressure algometry, a device that applies an increasing force over a limited constant surface, allows the quantification of the minimum pressure, which induces pain or discomfort, indicated as the PPT. PPT in the UT muscle area was assessed using a pressure algometer (JTECH Medical Commander Echo-Algometer with Console, Serial No-0d219167) by an experienced physiotherapist blinded to the intervention groups
Day one before the treatment, day one post treatment and day three follow-up
Upper trapezius' Surface Electromyographic activity
Time Frame: Day one before the treatment, day one post treatment and day three follow-up
The surface Electromyography (EMG) recording during the experimental condition and Maximum Voluntary Isometric Contraction (MVIC) of the UT muscle was performed using a BTS FREEEMG 1000 system (BTS Bioengineering, Milan, Italy) in three sessions: day one before and after treatment and day three follow-up. EMG data collected during the MVIC of the right-side UT muscle was used as a reference value to normalize the EMG activity of the experimental condition.
Day one before the treatment, day one post treatment and day three follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper trapezius' muscle length
Time Frame: Day one before the treatment, day one post treatment and day three follow-up
The upper trapezius length test was used to assess the UT muscle length. This involves gently lifting the patient's head off the table, flexing the neck slightly to take the upper trapezius to a lengthened position, and assessing the range of motion and any restrictions or discomfort experienced by the patient during this maneuver. This test is a valid assessment tool for identifying restrictions or tightness in the upper trapezius muscle. The reliability coefficients for muscle length were generally higher for the healthy group compared to the neck pain group, with ICC values ranging from 0.19 to 0.93 for the neck pain group and 0.40 to 0.93 for the healthy group
Day one before the treatment, day one post treatment and day three follow-up
Pain severity
Time Frame: Day one before the treatment, day one post treatment and day three follow-up
The severity of Upper Trapezius muscle pain was assessed using a visual analog scale (VAS: 0-10 cm, where 0 indicates no pain and 10 indicates severe pain), which has high intra- and inter-rater reliability to measure pain severity.
Day one before the treatment, day one post treatment and day three follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulf Medical University

Collaborators

Universidade do Sul de Santa Catarina

Investigators

  • Study Chair: Ramprasad Muthukrishnan, PhD, Gulf Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

April 25, 2024

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 29, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-COHS-FAC-28-OCT-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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