NCT05939583

Brief Summary

Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

July 3, 2023

Last Update Submit

March 12, 2024

Conditions

Cervicogenic Headache

Keywords

Shock wave therapyTrapezius trigger pointsCervicogenic headache

Outcome Measures

Primary Outcomes (4)

  • Visual analogue scale

    Assess degree of pain from 1 (No Pain) to 10 (Severe Pain)

    4 weeks

  • Neck disability index

    Assess degree of neck disability.

    4 weeks

  • Kinesiological EMG

    Analysis of root mean square for upper trapezius muscle functions.

    4 weeks

  • Kinesiological EMG

    Analysis of median frequency for upper trapezius muscle functions.

    4 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group will receive US, TENS, IR and exercises in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks

Other: Shock Wave TherapyOther: US, TENS, IR and exercises.

Control Group

EXPERIMENTAL

Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks

Other: US, TENS, IR and exercises.

Interventions

Shock Wave TherapyOTHER

Receiving Shock wave therapy + US, TENS, IR and exercises.

Also known as: US, TENS, IR and exercises.
Treatment Group
US, TENS, IR and exercises.OTHER

Receiving US, TENS, IR and exercises only.

Control GroupTreatment Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty patients from both genders.
  • Age ranging from 20 to 40 years.
  • Referred by an orthopedist with a diagnosis of Mechanical neck dysfunction (MND) to physical therapy at the outpatient clinic of the Faculty of Physical Therapy, MTI University.

You may not qualify if:

  • All other disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

El-Sheikh Zayed City, Giza Governorate, 1133, Egypt

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Extracorporeal Shockwave TherapyTranscutaneous Electric Nerve StimulationExercise

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and AnalgesiaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Of Neurological Physical Therapy - Faculty Of Physical Therapy - October 6 University

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

February 1, 2022

Primary Completion

September 1, 2022

Study Completion

February 1, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)