Dose Related Effects of Radial Extracorporeal Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache.

Dose Related Effects of Radial Extracorporeal Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache: A Randomized Controlled Trial

A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Participants will be assigned randomly into three groups Group (A) will receive 2000 shock waves at frequency 10 MHz and 0.045 mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (B) will receive 2000 shock waves at frequency 10 MHz and 0.18 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (C) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: sham shock wave therapy plus strengthening and stretching exercise for upper trapezius; Other: Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius; Other: Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Modern University for technology and information

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Symptoms of mechanical neck pain lasting for more than three months
• Skeletal muscle with a palpable taut band
• Hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated,
• Joint soreness in at least one of the upper cervical spine's joints (c1-c3)
• Unilateral discomfort that originates in the neck and radiates to the frontotemporal area
• Pain that is made worse by moving the neck
• Headaches that occur at least once a week for a duration longer than three months.

Exclusion Criteria:

• Other primary headaches (i.e., migraine, tension-type headache)
• Bilateral headaches,
• Other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Low dose shock wave therapy plus strengthening and stretching exercise.	Other: Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius; Patients will receive 2000 shocks, 1 bar (energy flux density 0.045 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching exercises for upper trapezius.
Experimental: Group B; Medium dose shock wave therapy on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius	Other: Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius; patients will receive 2000 shock with 4 bars (Energy flux density 0.18 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching for upper trapezius
Sham Comparator: Group C; Sham shock wave therapy plus strengthening and stretching exercises	Other: sham shock wave therapy plus strengthening and stretching exercise for upper trapezius; patients will receive 2000 shock with energy flus density 0.00 on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Henry Ford Hospital Headache disability inventory (HDI)	before the first session and after the last session (Four weeks)
Upper trapezius electromyographic activity	before the first session and after the last session (Four weeks)

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: shock wave therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Post-Traumatic Headache; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: P.T.REC/012/005500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No