Clinical trial
Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
Name
Dina Ahmed Sherif Sherif
Description
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.
Trial arms
Trial start
2023-05-06
Estimated PCD
2023-06-01
Trial end
2023-07-20
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Group (A)
Other names:
LEVELASER EZ1 EASYONE device
selected physical therapy program
hot pack, US for 5 min, exercise for 20 min.
Arms:
Group (A), Group (B)
Size
20
Primary endpoint
pain severity
before and after one month of treatment
F wave
before and after one month of treatment
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).
Protocol
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Updated at
2023-08-29
1 organization
1 product
1 indication
Organization
Cairo UniversityIndication
Cervical Radiculopathy