45 V vs 60 V Pulsed Radiofrequency of the Cervical Dorsal Root Ganglion for Cervical Radicular Pain

Official title

Does Higher Voltage Improve Outcomes in Cervical Radicular Pain? A Comparison of 45 V and 60 V Pulsed Radiofrequency of the Cervical Dorsal Root Ganglion

Overview

This study aims to compare the clinical outcomes of 45 V and 60 V pulsed radiofrequency (PRF) applied to the cervical dorsal root ganglion (DRG) in patients with cervical radicular pain. Treatment efficacy will be evaluated using the Numerical Rating Scale (NRS) for pain intensity and the Neck Disability Index (NDI) for functional disability. Procedure-related adverse events will also be compared to assess the safety of both voltage settings.

Detailed description

Pulsed radiofrequency (PRF) applied to the dorsal root ganglion (DRG) is a well-established minimally invasive treatment for patients with cervical radicular pain who do not respond adequately to conservative management. Although PRF has demonstrated favorable efficacy and safety, the optimal procedural parameters, particularly the applied voltage, remain uncertain. Previous studies have reported conflicting findings regarding the influence of voltage on treatment outcomes, with some suggesting improved long-term pain relief with higher voltages, while others have associated lower voltage settings with better clinical results. More recent evidence has shown favorable outcomes with higher-voltage PRF in cervical radicular pain; however, direct comparisons between commonly used voltage settings, such as 45 V and 60 V, are lacking.

The primary aim of this study is to compare the effectiveness of 45 V and 60 V PRF applied to the cervical DRG in patients with cervical radicular pain using the Numerical Rating Scale (NRS). Secondary aims include comparing functional outcomes using the Neck Disability Index (NDI) and evaluating the safety of both treatment protocols by comparing the incidence of procedure-related adverse events.

Patients who have undergone cervical DRG PRF for cervical radicular pain and completed their treatment will be evaluated according to the voltage applied during the procedure (45 V or 60 V). Pain intensity will be assessed using the Numerical Rating Scale (NRS), and functional disability will be evaluated using the Neck Disability Index (NDI) before treatment and at 3 and 6 months after the procedure. In addition to between-group comparisons, changes from baseline within each group will also be analyzed. Procedure-related adverse events will be recorded throughout the follow-up period.

Interventions

• Procedure 45 V cervical dorsal root ganglion pulsed radiofrequency
  After standard hemodynamic monitoring, the patient was placed in the supine position, and the cervical region was prepared using sterile technique. Under fluoroscopic guidance, the target cervical neural foramen was identified in anteroposterior and lateral views. Following local infiltration with 2 mL of 1% lidocaine, a radiofrequency cannula was advanced to the target cervical dorsal root ganglion. Correct needle placement was confirmed fluoroscopically and by sensory stimulation, which elicit
• Procedure 60 V cervical dorsal root ganglion pulsed radiofrequency
  After standard hemodynamic monitoring, the patient was placed in the supine position, and the cervical region was prepared using sterile technique. Under fluoroscopic guidance, the target cervical neural foramen was identified in anteroposterior and lateral views. Following local infiltration with 2 mL of 1% lidocaine, a radiofrequency cannula was advanced to the target cervical dorsal root ganglion. Correct needle placement was confirmed fluoroscopically and by sensory stimulation, which elicit

Primary outcome measures

• Numerical rating scale (NRS) [Time frame: Change from baseline to post-treatment at 3 and 6 months.]

Secondary outcome measures (1)

• Neck Disability Index (NDI) [Time frame: Change from baseline to post-treatment at 3 and 6 months.]

Eligibility criteria

Inclusion criteria

• Unilateral cervical radicular pain consistent with cervical disc herniation.
• Pain intensity of ≥6 on the Numerical Rating Scale (NRS).
• Radicular pain persisting for at least 3 months.
• MRI evidence of lower cervical nerve root compression consistent with clinical findings.
• Inadequate response to conservative treatment, including analgesic medications and physical therapy.
• Completion of cervical dorsal root ganglion pulsed radiofrequency (PRF) treatment.

Exclusion criteria

• Bilateral upper extremity pain or predominant axial neck pain.
• Cervical spinal stenosis, spondylolisthesis, cervical myelopathy, or other structural spinal disorders causing radicular pain.
• Previous cervical spine surgery at the target level.
• Cognitive impairment preventing reliable outcome assessment.
• Active local or systemic infection.
• Coagulopathy or inability to discontinue anticoagulant/antiplatelet therapy for the procedure.
• Severe hepatic or renal failure.
• Pregnancy.
• Unstable psychiatric disorders.
• Any condition that could interfere with completion of follow-up evaluations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07744438 · Cervical DRG PRF 45V vs 60V

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗