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

NCT ID: NCT06559358

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2024-12-30

Brief Summary

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

Detailed Description

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Conditions

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Pain Trigger Point Pain, Myofascial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

This group will receive subthreshold stimulation

Group Type EXPERIMENTAL

electrical stimulation

Intervention Type DEVICE

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

Group 2

This group will receive suprathreshold stimulation

Group Type EXPERIMENTAL

electrical stimulation

Intervention Type DEVICE

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

Group 3

This group will receive no stimulation

Group Type SHAM_COMPARATOR

electrical stimulation

Intervention Type DEVICE

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

Interventions

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electrical stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Mohamed

Associate Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Beni-Suef University2

Identifier Type: -

Identifier Source: org_study_id

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