Back to resultsEffect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Primary Purpose
Cervicogenic Headache
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Shock Wave Therapy
US, TENS, IR and exercises.
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Shock wave therapy, Trapezius trigger points, Cervicogenic headache
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: All other disorders.
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Group
Control Group
Arm Description
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
Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks
Outcomes
Primary Outcome Measures
Visual analogue scale
Assess degree of pain
Neck disability index
Assess degree of neck disability.
Kinesiological EMG
Will be used for analysis of upper trapezius muscle functions in forms of root mean square and median frequency
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05939583
Brief Title
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Official Title
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Shock wave therapy, Trapezius trigger points, Cervicogenic headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Shock Wave Therapy
Other Intervention Name(s)
US, TENS, IR and exercises.
Intervention Description
Receiving Shock wave therapy + US, TENS, IR and exercises.
Intervention Type
Other
Intervention Name(s)
US, TENS, IR and exercises.
Intervention Description
Receiving US, TENS, IR and exercises only.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Assess degree of pain
Time Frame
4 weeks
Title
Neck disability index
Description
Assess degree of neck disability.
Time Frame
4 weeks
Title
Kinesiological EMG
Description
Will be used for analysis of upper trapezius muscle functions in forms of root mean square and median frequency
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
All other disorders.
Facility Information:
Facility Name
October 6 University
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
1133
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
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