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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852613
• Other study ID #: Dina Ahmed Sherif Sherif
• Status: Completed
• Phase: Phase 3
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

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)

Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25. — View Citation

Barassi G, Supplizi M, Prosperi L, Irace G, Younes A, Della Rovere M, Rabini A, Colombo A, Di Iorio A. Dual-wavelength high-power laser therapy and neuromuscular manual therapy in chronic neck pain: a randomized clinical trial. J Biol Regul Homeost Agents. 2021 Mar-Apr;35(2):767-773. doi: 10.23812/21-37-L. No abstract available. — View Citation

Conforti M, Fachinetti GP. High power laser therapy treatment compared to simple segmental physical rehabilitation in whiplash injuries (1 degrees and 2 degrees grade of the Quebec Task Force classification) involving muscles and ligaments. Muscles Ligaments Tendons J. 2013 Jul 9;3(2):106-11. doi: 10.11138/mltj/2013.3.2.106. Print 2013 Apr. — View Citation

Kenareh R, Mirmohammadi SJ, Khatibi A, Shamsi F, Mehrparvar AH. The Comparison of The Efficacy of Photobiomodulation and Ultrasound in the Treatment of Chronic Non-specific Neck Pain: A Randomized Single-Blind Controlled Trial. J Lasers Med Sci. 2021 May 17;12:e20. doi: 10.34172/jlms.2021.20. eCollection 2021. — View Citation

Venosa M, Romanini E, Padua R, Cerciello S. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation in patients with cervical spondylosis: a randomized controlled trial. Lasers Med Sci. 2019 Jul;34(5):947-953. doi: 10.1007/s10103-018-2682-7. Epub 2018 Nov 15. — View Citation

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