Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients

Cervical Radiculopathy Clinical Trial

Official title: Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial

Status Completed

Clinical Trial 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) N=10: this group will receive high power laser therapy (HPLT) for 8 minutes in addition to selected physical therapy program

• group B (control group) N=10: 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.

Clinical Trial 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 G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) and revealed that the required sample size for this study is N=20.

Statistical analysis

• Descriptive statistics in form of mean, standard deviation and frequency will be conducted for the subject's 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 < 0.05.

• All statistical tests will be performed through the statistical package for social studies (SPSS) version 25 for windows. (IBM SPSS, Chicago, IL, USA). ;

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

• NCT number: NCT05852613
• Study type: Interventional
• Source: Cairo University
• Status: Completed
• Phase: Phase 3
• Start date: May 6, 2023
• Completion date: July 20, 2023