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

NCT06559358 | Not Yet Recruiting

• 1 other identifier: Beni-Suef University2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain; Trigger Point Pain, Myofascial

Outcome Measures

Primary Outcomes (4)

• Pain intensity

  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"

  2-3 months

• Pressure threshold

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

  2-3 months

• Electromyography

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

  2-3 months

• Range of motion

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

  2-3 months

Study Arms (3)

Group 1

EXPERIMENTAL

This group will receive subthreshold stimulation

Device: electrical stimulation

Group 2

EXPERIMENTAL

This group will receive suprathreshold stimulation

Device: electrical stimulation

Group 3

SHAM COMPARATOR

This group will receive no stimulation

Device: electrical stimulation

Interventions

electrical stimulation DEVICE

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

MeSH Terms

Conditions

Pain; Myofascial Pain Syndromes

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08