High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain

Minia University100 enrolled

Overview

The goal of this interventional study is to compare efficacy of either standard versus supra-voltage radiofrequency cervical epidural injection in pain alleviation in population with chronic cervical radiculopathy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Chronic Cervical Radiculopathy

Interventions

radiofrequency high voltageDEVICE

nvolved a high voltage PRF technique, where the voltage started at 65 V and could be adjusted up to 80 V based on patient tolerance. Both protocols involved two cycles of PRF application, with each cycle lasting 240 seconds and comprising alternating periods of current application and deactivation. The pulse rate frequency was set at 2 Hertz (Hz), resulting in two active phases/second (20 milliseconds (ms) of current application followed by 480 ms without stimulation)

standard RFPROCEDURE

A standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 70 years, both genders. * American Society of Anesthesiologists (ASA) physical status grades I or II. * Unilateral cervical radicular pain secondary to cervical disc prolapse affecting single nerve root which was refractory to conventional conservative and physiotherapy measures for 12 weeks or more. * All candidates received 1 millilitre of 2% lidocaine via an ultrasound-guided diagnostic nerve block and informed at least 50% momentary reduction of their pain. * Diagnosis was confirmed by cervical MRI and nerve conduction tests. Exclusion Criteria: * Refusal to participate. * Cervical radiculopathy pain recurrence after surgery. * Previous attempt of radiofrequency ablation. * Concomitant coagulopathic state ( decompensated liver disease, clopidogrel use) . * Metastatic lesion in the cervical vertebral column.

Locations (1)

Mina Raouf

Al Fayyum, Egypt

Outcomes

Primary Outcomes

visual analogue score

Number of patients with successful pain relief at 6 months post-intervention which is defined as more than or equal 50% reduction in VAS from pre-interventional level Vas score ranges from 0 to ten . 0= NO pain.... 1-3= mild pain .... 4-6 = moderate pain ... 6-10= severe untearable pain

Time frame: pre-treatment, 1,3, and 6 month after intervention

Secondary Outcomes

Neck disability index

1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment

Time frame: pre-treatment, 1,3 and 6 months after intervention

Incidence of procedure related adverse events

cervical epidural hematoma, nerve injury

Time frame: 6 hours after the procedure

Data from ClinicalTrials.gov

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