High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius

TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value

Study Overview

• Status: Active, not recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Device: TENs , ultrasound therapy

Detailed Description

Randomized controlled Trial , participants will be assigned into three groups (study group A ,study group B and study group c ) Subject selection will be 63 subjects , 21 subjects in each group with trigger points in the upper trapezius.

Groups

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• The age of patients range from 20 to 50 years .
• patient Body mass index starting from 19 to 25 kg\m.
• presence of myofascial trigger points in the shortened upper trapezius muscle evaluated .

Exclusion Criteria:

• patients with fibromyalgia syndrome.
• cancer or tumor or any type diagnosed .
• patients with disc herniation or spinal canal stenosis.
• pregnancy -
• patients diagnosed with epilepsy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high intensity laser , TENs and ultrasound and isometric exercise; Group A ( study group )will receive high intensity laser ,TENs , ultrasound therapy , and isometric exercise.	Device: TENs , ultrasound therapy; effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius; Other Names: high intensity (power) laser, ischemic compression; TENs , ultrasound therapy , isometric exercise and stretching exercise.
Experimental: ischemic compression ,TENs , ultrasound and isometric exercise; Group B ( study group) will receive ischemic compression ,TENs and ultrasound therapy and isometric exercise.	Device: TENs , ultrasound therapy; effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius; Other Names: high intensity (power) laser, ischemic compression; TENs , ultrasound therapy , isometric exercise and stretching exercise.
Experimental: TENs , ultrasound and isometric exercise; Group C (control group ) will receive TENs and ultrasound therapy and isometric exercise only.	Device: TENs , ultrasound therapy; effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius; Other Names: high intensity (power) laser, ischemic compression; TENs , ultrasound therapy , isometric exercise and stretching exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical range of motion (CROM)	All the cervical active movements will be measured by cervical range of motion device (CROM) especially in cervical flexion ,extension and medial and lateral rotation.one tester will document the results. cervical range of motion (cROM) will be measured by using Electronic CROM Goniometer in all ranges.	30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical pain	Cervical pain will be measured by Cervical range of motion device (CROM) .The patient will actively perform cervical movements in flexion ,extension and medial and lateral rotation then one tester will document the results as VAS will be used to measure pain levels .The VAS is a 10_cm line divided into 10 equal sections , with 10 expressing "unbearable pain " and 0 indicating no pain .each patient will be asked to point on this line to their level of neck pain .as pain level decreases ,the patient state improves. Pain will be assessed before and after treatment.	one minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure pain threshold (PPT)	Pressure pain threshold (PPT) ,measured by Algometer is defined as the point at which painless stimulation such as pressure turns into a painful sensation,so that we will measure PPT for each patient before and after treatment by one tester as pressure Algometry is a method that objectively describes PPT	10 seconds

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: RAGIAA KAMEL, PROFFESOR DR, RAGIAA M KAMEL , PROF DR

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 10, 2024
• First Submitted That Met QC Criteria: August 10, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: "myofascial pain syndrome" "trigger points" "high intensity laser " "ischemic compression"
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 012\005287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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