Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females

Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females

Study Overview

• Status: Completed
• Conditions: Tension-Type Headache
• Intervention / Treatment: Device: Extracorporeal Shockwave Therapy

Detailed Description

The prevalence of headaches increases with age, with a prevalence of 82% during adolescence. Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kerolous ishak shehata kelini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Suffering from chronic tension headache (headaches occur 15 or more days a month for at least three months).
• Their age will range from 15 to 18 years.
• Having a sedentary lifestyle (A weekly physical activity of < 600 MET-minutes/ week in the international physical activity questionnaire)
• Having regular menstruation (28 to 34 days).

Exclusion Criteria:

• Using oral contraceptives or
• any hormonal treatment in the previous six months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; receive exercise program for 20-30 min which include include cervical ROM to warm up,cool down, and stretching of cervical, upper thoracic spine (trapezius,levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric,concentric conctration of deep flexor muscles) each exercise consist of three sets of five to ten repetitions will be performed with 30-60S rest period between sets	Device: Extracorporeal Shockwave Therapy; Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia.
Experimental: Study group; receive Extracorporeal Shockwave Therapy and the same exercise program as group A, three sessions per week for 12 weeks (3 menstrual cycles).	Device: Extracorporeal Shockwave Therapy; Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
digital algometer	Measure pain intensity pre and post treatment which tested the pain points of the muscles: upper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally.	The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Electromyography (EMG) for neck muscles	Measure muscle activity pre and post treatmentupper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally	The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Headache impact test questionnaire	The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.	The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Study Director: Kerolous IS kelini, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: P.T.REC/012/004547

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