Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points

Effect of Subthreshold Stimulation on Pain and Muscle Activity in Patients With Chronic Low Neck Pain and Myofascial Trigger Points

This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Device: Subthreshold Electrical stimulation

Detailed Description

The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• chronic neck pain
• One or more trigger point

Exclusion Criteria:

• any musculoskeletal or neuromuscular diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; This group will receive subthreshold stimulation	Device: Subthreshold Electrical stimulation; We will use a electrotherapy device to deliver subthreshold Electrical stimulation
No Intervention: Group II; This group will receive no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographical signals	We will record the the Trapezius muscle activity of both sides.	2 months
Pressure sensitivity using pressure ergometer	We will measure pain threshold produced from Trapezius muscle	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain and disability	We will record the level of pain and disability in neck using neck pain and disability index. standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score	2 months
Functional ability	We will measure the functional ability. The Copenhagen Neck Functional Disability Scale has been developed for those who have neck pain and disabilities due to the pain. The scale includes questions relating to headache, ability to sleep and to concentrate and activities of daily living.	2 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Beni-Suef University 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No