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

Comparison Between the Effectiveness of Ultrasound-Guided High Voltage Pulsed Radiofrequency Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots in Patients With Refractory Chronic Unilateral Cervical Radicular Pain

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 Overview

• Status: Completed
• Conditions: Chronic Cervical Radiculopathy
• Intervention / Treatment: Device: radiofrequency high voltage; Procedure: standard RF

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 61511
    • Mina Raouf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group H ( high voltage) radiofrequency; Group H, involved 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).	Device: radiofrequency high voltage; 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)
Active Comparator: Group S ( standard) radiofrequency; utilized a standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V).	Procedure: standard RF; A standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-treatment, 1,3, and 6 month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck disability index	1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment	pre-treatment, 1,3 and 6 months after intervention
Incidence of procedure related adverse events	cervical epidural hematoma, nerve injury	6 hours after the procedure

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: R-247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No