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

NCT07744438 | Recruiting

• 1 other identifier: Cervical DRG PRF 45V vs 60V
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Radicular Pain

Keywords

Pulsed Radiofrequency Treatment; Dorsal Root Ganglion; Voltage; Neck Disability Index

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

  Change from baseline to post-treatment at 3 and 6 months.

Secondary Outcomes (1)

• Neck Disability Index (NDI)

  Change from baseline to post-treatment at 3 and 6 months.

Study Arms (2)

45 V cervical DRG pulsed radiofrequency group

ACTIVE COMPARATOR

45 V pulsed radiofrequency applied to the cervical dorsal root ganglion for the treatment of cervical radicular pain.

Procedure: 45 V cervical dorsal root ganglion pulsed radiofrequency

60 V cervical DRG pulsed radiofrequency group

ACTIVE COMPARATOR

60 V pulsed radiofrequency applied to the cervical dorsal root ganglion for the treatment of cervical radicular pain.

Procedure: 60 V cervical dorsal root ganglion pulsed radiofrequency

Interventions

45 V cervical dorsal root ganglion pulsed radiofrequency PROCEDURE

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 elicited concordant paresthesia in the corresponding dermatome. Pulsed radiofrequency was then applied for 240 seconds at a maximum temperature of 42°C using a voltage of 45 V. After completion of the procedure, the cannula was removed, a sterile dressing was applied, and patients were observed for 60 minutes before discharge.

45 V cervical DRG pulsed radiofrequency group

60 V cervical dorsal root ganglion pulsed radiofrequency PROCEDURE

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 elicited concordant paresthesia in the corresponding dermatome. Pulsed radiofrequency was then applied for 240 seconds at a maximum temperature of 42°C using a voltage of 60 V. After completion of the procedure, the cannula was removed, a sterile dressing was applied, and patients were observed for 60 minutes before discharge.

60 V cervical DRG pulsed radiofrequency group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

• Gokhan Yildiz

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gokhan Yildiz

CONTACT

5059272589; gkoyldz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

TU (1)