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NCT Number: NCT06559358

Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain

this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.

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Key information

Conditions

Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigger Point Pain, Myofascial

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 40 to 65 years old participated in this study, 2
  • Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
  • Having one or more trigger points in the upper trapezius muscle,
  • A significant increase in neck muscle EMG activity indicates the presence of tender points.

Exclusion criteria

  • Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
  • Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
  • Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities

Treatment and study plan

Electrical Stimulation

Device

A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).

Primary outcomes

  1. Pain intensity

    Time frame: 2-3 months

    Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain"

  2. Pressure threshold

    Time frame: 2-3 months

    Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle.

  3. Electromyography

    Time frame: 2-3 months

    The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.

  4. Range of motion

    Time frame: 2-3 months

    Flexion, lateral rotation to both sides, lateral flexion to both sides

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 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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