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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05852613
Other study ID # Dina Ahmed Sherif Sherif
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 6, 2023
Est. completion date July 20, 2023

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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).


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
high power laser therapy (HPLT)
high power laser therapy (HPLT) will be produced by A LEVELASER EZ1 EASYONE device which produces a Ga Al As CW diode laser with pulsed emission 980 nm and maximum average power 5 W with a high level of energy penetration. While the patient is in a prone position and the head slightly bends to the front, The treatment will be performed at a distance of 60-70 cm, perpendicular to the cervical region, in a pulsed mode of 4 Hz, wavelength = 980 nm, radiation power density P = 4 W in the scan phase and 2 W in the acupuncture phase and energy 840 J. Patients will receive pulsed HPLT laser treatment for 8 minutes. Scanning will be performed transversely and longitudinally to the bilateral paraspinal muscles, inter-scapular area, upper trapezius and the neck region for 6 minutes followed by 2 minutes acupuncture. Protective goggles will be used to prevent direct eye contact of the laser beam.
Combination Product:
selected physical therapy program
hot pack, US for 5 min, exercise for 20 min.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo University Cairo El Behoth

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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Outcome

Type Measure Description Time frame Safety issue
Primary pain severity using a 0-10 cm visual analog scale (VAS). Patients were asked to make a handwritten mark on a 100 mm line (10cm). This line represents a continuum between no pain or discomfort (zero), to the worst pain (10) that the patient could feel. The measure was taken by a ruler from the starting point of the scale to the mark the patient scored in millimeters.
The results were interpreted as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm), (Jensen 2003). Patients should have moderate to severe neck pain to be included in the study. The pain intensity was recorded before and after the study.
before and after one month of treatment
Primary F wave for both median and ulnar nerves of both upper extremities before and after one month of treatment
Secondary nerve conduction studies (NCS) for both median and ulnar nerves of both upper extremities before and after one month of treatment
Secondary electromyography (EMG) using a bipolar needle electrode to biceps brachii, triceps and first dorsal interosseus muscles of both upper extremities. before and after one month of treatment
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