Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points

NCT ID: NCT06604962

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-28
• Study Completion Date: 2024-04-25

Brief Summary

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.

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

Conditions

Myofacial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I: IMES using IEP

Participants in this group has allocated to the Intramuscular electrical stimulation using inverse electrode placement

Group Type: EXPERIMENTAL

IMES using IEP

Intervention Type: PROCEDURE

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

Group II: IMES using CEP

Participants in this group has allocated to the Intramuscular electrical stimulation using conventional electrode placement

Group Type: ACTIVE_COMPARATOR

IMES using CEP

Intervention Type: PROCEDURE

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.

Group III: Sham-IMES

Participants in this group has allocated to the Sham Intramuscular electrical stimulation

Group Type: SHAM_COMPARATOR

Sham-IMES

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Sul de Santa Catarina

OTHER_GOV

Sponsor Role: collaborator

Gulf Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramprasad Muthukrishnan, PhD

Role: STUDY_CHAIR

Gulf Medical University

Locations

Gulf Medical University

Ajman, , United Arab Emirates

Countries

United Arab Emirates

References

Shanmugam S. Inverse Electrode Placement May Help to Improve Electrotherapeutic Effects in the Field of Chronic Pain Management. Korean J Pain. 2016 Jul;29(3):202-4. doi: 10.3344/kjp.2016.29.3.202. Epub 2016 Jul 1. No abstract available.

Reference Type: BACKGROUND

PMID: 27413488 (View on PubMed)

Shanmugam S, Mathias L, Thakur A, Kumar D. Effects of Intramuscular Electrical Stimulation Using Inversely Placed Electrodes on Myofascial Pain Syndrome in the Shoulder: A Case Series. Korean J Pain. 2016 Apr;29(2):136-40. doi: 10.3344/kjp.2016.29.2.136. Epub 2016 Apr 1.

Reference Type: BACKGROUND

PMID: 27103970 (View on PubMed)

Shanmugam S, Mathias L, Manickaraj N, Kumar KUD, Kandakurti PK, Dorairaj SK, Muthukrishnan R. Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial. Int J Surg Protoc. 2021 May 18;25(1):71-83. doi: 10.29337/ijsp.25.

Reference Type: BACKGROUND

PMID: 34056148 (View on PubMed)

Other Identifiers

IRB-COHS-FAC-28-OCT-2023

Identifier Type: -

Identifier Source: org_study_id