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

Minia University

Status: Completed

Conditions: Chronic Cervical Radiculopathy

Treatments: Procedure: standard RF; Device: radiofrequency high voltage

Study type: Interventional

Funder types: Other

Identifiers

NCT05749185

R-247

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group H ( high voltage) radiofrequency

Active Comparator group

Description:

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).

Treatment:

Device: radiofrequency high voltage

Group S ( standard) radiofrequency

Active Comparator group

Description:

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

Treatment:

Procedure: standard RF