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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-06

Study Completion Date

2023-07-20

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.

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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).

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group (A)

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.

Group Type EXPERIMENTAL

high power laser therapy (HPLT)

Intervention Type DEVICE

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.

selected physical therapy program

Intervention Type COMBINATION_PRODUCT

hot pack, US for 5 min, exercise for 20 min.

Group (B)

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 .

Group Type ACTIVE_COMPARATOR

selected physical therapy program

Intervention Type COMBINATION_PRODUCT

hot pack, US for 5 min, exercise for 20 min.

Interventions

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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.

Intervention Type DEVICE

selected physical therapy program

hot pack, US for 5 min, exercise for 20 min.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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LEVELASER EZ1 EASYONE device

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).

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No