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

2026年7月29日 更新者:Gökhan Yıldız、Ankara Etlik City Hospital

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

58

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Numerical rating scale (NRS)
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Neck Disability Index (NDI)
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gokhan Yildiz、Ankara Etlik City Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月29日

初级完成 (估计的)

2027年2月26日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Cervical DRG PRF 45V vs 60V

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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