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

Not Applicable

Completed

• Conditions: Chronic Cervical Radiculopathy
• Interventions: Device: radiofrequency high voltage; Procedure: standard RF

• Registration Number: NCT05749185
• Lead Sponsor: Minia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-18
• Study Start: 2023-02-22
• Study First Posted: 2023-03-01
• Primary Completion: 2024-03-12
• Study Completion: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group H ( high voltage) radiofrequency	radiofrequency high voltage	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).
Group S ( standard) radiofrequency	standard RF	utilized a standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V).

Primary Outcome Measures

Name	Time	Method
visual analogue score	pre-treatment, 1,3, and 6 month after intervention	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mina Raouf; 🇪🇬 Fayoum, Egypt