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

August 16, 2024 updated by: Ayman Mohamed, Beni-Suef University
this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
This group will receive subthreshold stimulation
Device: electrical stimulation
A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).
Experimental: Group 2
This group will receive suprathreshold stimulation
Device: electrical stimulation
A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).
Sham Comparator: Group 3
This group will receive no stimulation
Device: electrical stimulation
A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
2-3 months
Pressure threshold
Time Frame: 2-3 months
Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle.
2-3 months
Electromyography
Time Frame: 2-3 months
The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.
2-3 months
Range of motion
Time Frame: 2-3 months
Flexion, lateral rotation to both sides, lateral flexion to both sides
2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef University2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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