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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Cervical Radiculopathy

Treatments: Combination Product: selected physical therapy program; Device: high power laser therapy (HPLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05852613

Dina Ahmed Sherif Sherif

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group (A)

Experimental group

Description:

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.

Treatment:

Combination Product: selected physical therapy program

Device: high power laser therapy (HPLT)

Group (B)

Active Comparator group

Description:

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 .

Treatment:

Combination Product: selected physical therapy program