Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): high power laser therapy (HPLT); selected physical therapy program
Intervention type(s): Device; Combination Product
Intervention description(s): 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.; hot pack, US for 5 min, exercise for 20 min.
Other intervention name(s): LEVELASER EZ1 EASYONE device
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High power laser therapy; Cervical radiculopathy; Electrophysiological study; nerve conduction study; electromyography