Clinical trial NCT06604962: Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofacial Pain Syndrome
Keywords: Myofascial trigger points
Electrical stimulation
Pressure pain threshold
Electromyography
Intramuscular stimulation
Intramuscular electrical stimulation
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
Collaborators: name: Universidade do Sul de Santa Catarina
First posted: 2024-09-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an experimental study to study the effects of intramuscular electrical stimulation using different electrode placements over sham comparator group
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: Day one before the treatment, day one post treatment and day three follow-up
measure: Upper trapezius' Surface Electromyographic activity
timeFrame: Day one before the treatment, day one post treatment and day three follow-up
Secondary outcomes:
measure: Pain severity
timeFrame: Day one before the treatment, day one post treatment and day three follow-up
measure: Upper trapezius' muscle length
timeFrame: Day one before the treatment, day one post treatment and day three follow-up
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Gulf Medical University
Study officials:
affiliation: Gulf Medical University
name: Ramprasad Muthukrishnan, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.