NCT06482736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 22, 2024

Last Update Submit

June 27, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

Control group

EXPERIMENTAL

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

Study group

EXPERIMENTAL

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

Interventions

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.

Control groupStudy group

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerolous Ishak Shehata Kelini

Cairo, Egypt

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kerolous IS kelini

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 22, 2024

First Posted

July 1, 2024

Study Start

January 5, 2023

Primary Completion

August 8, 2023

Study Completion

January 22, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations