Back to resultsLow Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
Primary Purpose
Disc Degeneration
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low level Lazer therapy
Routine exercises
Sponsored by
About this trial
This is an interventional treatment trial for Disc Degeneration
Eligibility Criteria
Inclusion Criteria: elderly patients with age range between 60 and 75 years old. with cervical disc degeneration. Exclusion Criteria: patients with uncontrolled hypertension. Patients with uncontrolled diabetes mellitus. Patients with severe cardiac or chest diseases.
Sites / Locations
- Shymaa yussuf abo zaid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lazer group
Control group
Arm Description
30 patients will receive low level lazer therapy 3 times per week for 12 weeks.
30 patients will receive only exercises.
Outcomes
Primary Outcome Measures
Resistivity index of both right and left vertebral arteries
Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT06025175
First Posted
August 20, 2023
Last Updated
September 2, 2023
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT06025175
Brief Title
Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
Official Title
Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley 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
This study will include 60 elderly patients with cervical disc degeneration, from both gender who are aged from 60 - 75 years old.
Detailed Description
The 60 patients will divided into two groups, with 30 patients in each group. group(A): will receive low level lazer and exercises for three times per week for 12 weeks.
Group (B): will receive only exercises. Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups Group (A) and group(B)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lazer group
Arm Type
Experimental
Arm Description
30 patients will receive low level lazer therapy 3 times per week for 12 weeks.
Arm Title
Control group
Arm Type
Other
Arm Description
30 patients will receive only exercises.
Intervention Type
Radiation
Intervention Name(s)
Low level Lazer therapy
Intervention Description
30 patients will receive low level lazer therapy 3 times a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Routine exercises
Intervention Description
30 patients will receive only routine exercises 3 times a week for 12 weeks.
Primary Outcome Measure Information:
Title
Resistivity index of both right and left vertebral arteries
Description
Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
elderly patients with age range between 60 and 75 years old.
with cervical disc degeneration.
Exclusion Criteria:
patients with uncontrolled hypertension.
Patients with uncontrolled diabetes mellitus.
Patients with severe cardiac or chest diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shymaa Y Abo zaid
Phone
01010941685
Ext
01091631018
Email
shaymaayoussef397@gmail.com
Facility Information:
Facility Name
Shymaa yussuf abo zaid
City
Qinā
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shymaa Y Abo zaid, Doctoral
Phone
01010941685
Ext
01091631018
Email
shaymaayoussef397@gmail.com
First Name & Middle Initial & Last Name & Degree
Shymaa Y Abo zaid, Doctoral
Phone
01010941685
Ext
01010941685
12. IPD Sharing Statement
Learn more about this trial
Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
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