45 V vs 60 V Pulsed Radiofrequency of the Cervical Dorsal Root Ganglion for Cervical Radicular Pain
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gokhan Yildiz
- Phone Number: TR 5059272589
- Email: gkoyldz@gmail.com
Study Locations
-
-
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Gokhan Yildiz
- Phone Number: TR 5059272589
- Email: gkoyldz@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 45 V cervical DRG pulsed radiofrequency group
45 V pulsed radiofrequency applied to the cervical dorsal root ganglion for the treatment of cervical radicular pain.
|
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.
|
|
Active Comparator: 60 V cervical DRG pulsed radiofrequency group
60 V pulsed radiofrequency applied to the cervical dorsal root ganglion for the treatment of cervical radicular pain.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale (NRS)
Time Frame: Change from baseline to post-treatment at 3 and 6 months.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (NDI)
Time Frame: Change from baseline to post-treatment at 3 and 6 months.
|
NDI is a validated questionnaire used to assess functional disability associated with neck pain.
Scores range from 0 to 50, with higher scores indicating greater disability.
|
Change from baseline to post-treatment at 3 and 6 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gokhan Yildiz, Ankara Etlik City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Cervical DRG PRF 45V vs 60V
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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