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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Device: high power laser therapy (HPLT)
* Combination Product: selected physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Twenty patients with unilateral cervical radiculopathy due to disc prolapse at the level of C5 - C6 or C6 - C7. Age ranges from 30 to 50 years. Patients will be both sexes. Patients will be diagnosed by clinical and radiological examination. Presence of sensory changes as pain and paresthesia (numbness, tingling, burning) in the upper extremity. Pain severity should be moderate or severe. Reporting a minimum pain score of 4 on a 10-point Visual Analogue Scale (VAS). Duration of pain ranges from (3-12) months. Exclusion Criteria: Diabetic patient. Patients with peripheral neuropathy or entrapment syndrome. Previous cervical or shoulder surgery. Fracture of the bones of upper extremity. Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The current study will include twenty patients with unilateral cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7. Patients will be diagnosed on the basis of clinical (history and physical examination) and radiological examination (MRI). All subjects will be evaluated using the same procedures. - Patients will be randomly assigned into two equal matched groups Group (A) study group: (N=10) this group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program (hot pack, US for 5 min, exercise for 20min) for 8 session two times weekly for 4 weeks. 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 attended the physical therapy clinic two times weekly for 4 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (A)<br>this group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program for 8 session two times weekly for 4 weeks. | Device: high power laser therapy (HPLT)<br>* 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.<br>* Other names: LEVELASER EZ1 EASYONE device;Combination Product: selected physical therapy program<br>* hot pack, US for 5 min, exercise for 20 min.<br>|
| Active Comparator: Group (B)<br>this group will receive the same selected physical therapy program only for 8 session. All patients will attended the physical therapy clinic two times weekly for 4 weeks . | Combination Product: selected physical therapy program<br>* hot pack, US for 5 min, exercise for 20 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| F wave | for both median and ulnar nerves of both upper extremities | before and after one month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nerve conduction studies (NCS) | for both median and ulnar nerves of both upper extremities | before and after one month of treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electromyography, High power laser therapy, Cervical radiculopathy, Electrophysiological study, nerve conduction study