Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852613
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2023-04-27
Brief Title:
Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is
To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy
The main question it aims to answer
Is there a significant effect of high power laser therapy HPLT on pain and electrophysiological study in patients with cervical radiculopathy
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 will randomly assigned into two equal matched groups
group A study group N10 this group will receive high power laser therapy HPLT for 8 minutes in addition to selected physical therapy program
group B control group N10 this group will receive the same selected physical therapy program only hot pack US for 5 min exercise for 20 min for 8 session
All patients will attend the physical therapy clinic two times weekly for 4 weeks
The evaluation was done by nerve conduction study NCS and needle electromyography EMG before and after the treatment in addition to visual analogue scale VAS
HYPOTHESES
Null hypothesis There is no significant effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy
To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy
The main question it aims to answer
Is there a significant effect of high power laser therapy HPLT on pain and electrophysiological study in patients with cervical radiculopathy
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 will randomly assigned into two equal matched groups
group A study group N10 this group will receive high power laser therapy HPLT for 8 minutes in addition to selected physical therapy program
group B control group N10 this group will receive the same selected physical therapy program only hot pack US for 5 min exercise for 20 min for 8 session
All patients will attend the physical therapy clinic two times weekly for 4 weeks
The evaluation was done by nerve conduction study NCS and needle electromyography EMG before and after the treatment in addition to visual analogue scale VAS
HYPOTHESES
Null hypothesis There is no significant effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy
Detailed Description:
This current study will be designed to determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy This study will be carried out at outpatient clinic of Faculty of Physical Therapy Cairo University
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 cervical radiculopathy will be selected from outpatient clinic of Faculty of Physical Therapy Cairo University and outpatient clinic of Qasr El- Aini Hospitals
On approval to participate in the study all subjects will sign an informed consent form after receiving full information on the purpose of study procedure possible benefits privacy and use of data and their rights to withdraw from the study whenever they want
Sample size
Sample size calculation is performed using GPOWER statistical software version 3192 Franz Faul Universitat Kiel Germany and revealed that the required sample size for this study is N20
Statistical analysis
Descriptive statistics in form of mean standard deviation and frequency will be conducted for the subjects demographics and collected data
Paired samples T Test procedure will be used to compare the means of two variables for a single group
Independent sample T Test Procedure will be used to compares means for two groups
Pearson Correlation Coefficient will be conducted to determine the correlation between electrophysiological study and pain intensity
The level of significance for all statistical tests will be set at p 005
All statistical tests will be performed through the statistical package for social studies SPSS version 25 for windows IBM SPSS Chicago IL USA
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 cervical radiculopathy will be selected from outpatient clinic of Faculty of Physical Therapy Cairo University and outpatient clinic of Qasr El- Aini Hospitals
On approval to participate in the study all subjects will sign an informed consent form after receiving full information on the purpose of study procedure possible benefits privacy and use of data and their rights to withdraw from the study whenever they want
Sample size
Sample size calculation is performed using GPOWER statistical software version 3192 Franz Faul Universitat Kiel Germany and revealed that the required sample size for this study is N20
Statistical analysis
Descriptive statistics in form of mean standard deviation and frequency will be conducted for the subjects demographics and collected data
Paired samples T Test procedure will be used to compare the means of two variables for a single group
Independent sample T Test Procedure will be used to compares means for two groups
Pearson Correlation Coefficient will be conducted to determine the correlation between electrophysiological study and pain intensity
The level of significance for all statistical tests will be set at p 005
All statistical tests will be performed through the statistical package for social studies SPSS version 25 for windows IBM SPSS Chicago IL USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None