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

NCT06879418 | Completed DMC

• 1 other identifier: P.T.REC/012/005500
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervicogenic Headache

Keywords

shock wave therapy

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Group A

EXPERIMENTAL

Low dose shock wave therapy plus strengthening and stretching exercise.

Other: Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius

Group B

EXPERIMENTAL

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

Group C

SHAM COMPARATOR

Sham shock wave therapy plus strengthening and stretching exercises

Other: sham shock wave therapy plus strengthening and stretching exercise for upper trapezius

Interventions

Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius OTHER

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.

Group A

Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius OTHER

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

Group B

sham shock wave therapy plus strengthening and stretching exercise for upper trapezius OTHER

patients will receive 2000 shock with energy flus density 0.00 on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius.

Group C

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Modern University for Technology and Information

Cairo, Egypt

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Basic Science, Faculty of Physical Therapy, MTI University.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: March 17, 2025
• Study Start: March 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 15, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-10

Locations

EG (1)