Clinical trial NCT05852613: Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients
Official title: Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Radiculopathy
Keywords: High power laser therapy
Cervical radiculopathy
Electrophysiological study
nerve conduction study
electromyography
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: pain severity
timeFrame: before and after one month of treatment
measure: F wave
timeFrame: before and after one month of treatment
Secondary outcomes:
measure: nerve conduction studies (NCS)
timeFrame: before and after one month of treatment
measure: electromyography (EMG)
timeFrame: before and after one month of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: El Behoth
Study officials:
affiliation: Cairo University
name: Ashraf A Darwish
role: STUDY_CHAIR
References:
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.
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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.
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.
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.