Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points

NCT06604962 | Completed DMC

• 1 other identifier: IRB-COHS-FAC-28-OCT-2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain Syndrome

Keywords

Myofascial trigger points; Electrical stimulation; Pressure pain threshold; Electromyography; Intramuscular stimulation; Intramuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Pressure pain threshold (PPT)

  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

  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 Outcomes (2)

• Pain severity

  Day one before the treatment, day one post treatment and day three follow-up

• Upper trapezius' muscle length

  Day one before the treatment, day one post treatment and day three follow-up

Study Arms (3)

Group I: IMES using IEP

EXPERIMENTAL

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

Procedure: IMES using IEP

Group II: IMES using CEP

ACTIVE COMPARATOR

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

Procedure: IMES using CEP

Group III: Sham-IMES

SHAM COMPARATOR

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

Other: Sham-IMES

Interventions

IMES using IEP 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 I: IMES using IEP

IMES using CEP 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 II: IMES using CEP

Sham-IMES 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

Group III: Sham-IMES

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulf Medical University: lead
• Universidade do Sul de Santa Catarina: collaborator

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

Related Publications (3)

• 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.

  PMID: 27413488 BACKGROUND

• 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.

  PMID: 27103970 BACKGROUND

• 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.

  PMID: 34056148 BACKGROUND

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Ramprasad Muthukrishnan, PhD

  Gulf Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each random number concealed within the small opaque envelope, later all numbers concealed within the large opaque envelope. An independent researcher who was not part of the study generated 36 random (computer generated) numbers, and an office clerk was involved in the allotment of the specified interventions. The intervention provider, outcome assessors and statistician are blinded to interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an experimental study to study the effects of intramuscular electrical stimulation using different electrode placements over sham comparator group

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 20, 2024
• Study Start: October 28, 2023
• Primary Completion: March 30, 2024
• Study Completion: April 25, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)