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NCT Number: NCT06604962

Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points

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.

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Key information

Conditions

Myofacial Pain Syndrome Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulf Medical University

Ajman, 4184, United Arab Emirates

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Collaborators

  • Universidade do Sul de Santa Catarina

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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