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临床试验/NCT07021365
NCT07021365尚未招募不适用

Comparison of Ganglion Impar Radiofrequency Ablation and Phenol Neurolysis Techniques for Chronic Coccydynia Treatment

Marmara University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Numeric Rating Scale-11

研究概览

简要总结

Radiofrequency ablation and phenol neurolysis of the ganglion impar are methods used in cases unresponsive to medication, particularly in patients who derive short-term or partial relief from the initial ganglion impar block. In clinical practice, clinicians frequently use these two injections in patients with treatment-resistant pain who only partially benefit from the initial blockade procedure.

To date, the medical literature lacks a comprehensive study comparing the efficacy of radiofrequency ablation and phenol neurolysis in patients who partially benefit from ganglion impar block. Therefore, this study is designed to compare the effectiveness of these two methods in patients with chronic coccydynia.

详细描述

Ganglion impar radiofrequency ablation and phenol neurolysis are treatment options for patients who do not respond to medication, especially those experiencing only temporary or partial relief from an initial ganglion impar block. In clinical practice, these two injection techniques are commonly employed in managing persistent pain in such cases.

Radiofrequency Ablation (RFA):

This technique aims to eliminate pain by thermally damaging the nerves that carry pain sensations. Under real-time imaging guidance, a radiofrequency needle is advanced through the intervertebral disc from the tailbone region to the anatomical area called the ganglion impar. The needle tip location is confirmed with contrast dye. At this point, motor and sensory stimulation is applied to ensure the needle is not affecting motor function and to identify the site where the pain stimulus matches the patient's complaint. Once confirmed, heat application is initiated. Prior to heat delivery, a local anesthetic is administered to ensure the procedure is painless.

Phenol Neurolysis:

This method aims to chemically destroy the nerves carrying pain signals from the coccyx area using phenol. The procedure is performed similarly to RFA: a radiofrequency needle is inserted through the disc between spinal bones under real-time imaging guidance to reach the ganglion impar. After confirming the needle position with contrast dye, a local anesthetic is administered, and then phenol is applied to chemically ablate the sensory fibers without pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Presence of chronic coccydynia lasting at least 3 months
  • Pre-procedural pain score of 4 or higher on the Numeric Rating Scale (NRS)
  • Patients who have undergone a ganglion impar block within the last 3 months and experienced limited benefit (i.e., less than 50% reduction in pain compared to pre-treatment) and/or short-term relief (less than 4 weeks)

排除标准

  • History of surgery involving the sacrococcygeal region
  • Prior treatment with ganglion impar phenol neurolysis or radiofrequency ablation
  • Coagulopathies (bleeding disorders)
  • Infection
  • Spondylolisthesis, scoliosis, or lumbar spinal stenosis
  • Malignancy
  • Pregnancy
  • History of allergic reaction to the administered injectates
  • History of major psychiatric illness

研究组 & 干预措施

Ganglion Impar Radiofrequency Ablation

Active Comparator

干预措施: Radiofrequency ablation alone (Device)

Ganglion Impar Phenol Neurolysis

Active Comparator

干预措施: Phenol Injection (Drug)

结局指标

主要结局

Numeric Rating Scale-11

时间窗: Treatment to 6 months post-treatment

A subjective outcome measure to assess pain (Min:0 Max:10). Higher scores indicate more severe pain.

次要结局

  • Short Form-12 Health Survey(Treatment to 6 months post-treatment.)
  • Douleur Neuropathique 4(Treatment to 6 months post-treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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