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临床试验/NCT07509593
NCT07509593招募中不适用

Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia

Marmara University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Change in pain intensity (Numeric Rating Scale, NRS)

研究概览

简要总结

This study aims to compare two commonly used radiofrequency ablation (RFA) techniques for the treatment of chronic tailbone (coccyx) pain, also known as coccydynia. Chronic coccydynia can significantly impair daily activities and reduce quality of life, particularly in patients who do not respond adequately to conservative treatments. Participants in this study will be randomly assigned to receive either a single-level or double-level radiofrequency ablation (RFA) procedure targeting the coccygeal nerve pathways. These procedures are minimally invasive and are routinely performed in pain management practice. The primary objective of the study is to determine which technique provides superior pain relief and functional improvement. Patients will be followed for up to two months after the procedure, and pain intensity and quality of life will be evaluated using validated outcome measures. The results of this study may help optimize interventional treatment strategies for patients suffering from chronic coccydynia.

详细描述

Chronic coccydynia is a persistent pain condition localized to the coccygeal region, often exacerbated by sitting and significantly impairing quality of life. While conservative treatments such as pharmacotherapy, physical therapy, and local injections may provide relief, a subset of patients remains refractory to these approaches. Radiofrequency ablation (RFA) targeting the ganglion impar has emerged as an effective minimally invasive option for managing refractory coccydynia.

Different technical approaches to ganglion impar RFA have been described, including single-level and double-level lesioning techniques. However, there is limited evidence directly comparing the clinical efficacy of these approaches. It remains unclear whether creating lesions at two levels provides superior pain relief and functional outcomes compared to a single-level approach.

This prospective randomized controlled study aims to compare the effectiveness of single-level versus double-level radiofrequency ablation of the ganglion impar in patients with chronic coccydynia who previously responded to diagnostic or therapeutic ganglion impar block but experienced recurrence of pain. The primary objective is to evaluate pain reduction, while secondary objectives include assessment of functional status and quality of life over a two-month follow-up period.

All procedures will be performed under fluoroscopic guidance using standardized techniques. Patients will be evaluated at baseline and at predefined follow-up intervals using validated outcome measures. The findings of this study are expected to contribute to optimizing interventional treatment strategies for chronic coccydynia.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with coccygeal pain lasting longer than 2 months
  • Patients who experienced significant pain relief (≥50% reduction) after a ganglion impar block performed within the last 6 months, but whose pain has subsequently recurred
  • Patients who provide informed consent to participate in the study

排除标准

  • Acute coccydynia (pain duration less than 2 months)
  • Patients who did not achieve significant benefit (<50% pain reduction) from prior ganglion impar block
  • Patients with severe neurological or psychiatric disorders that impair communication or ability to follow instructions

研究组 & 干预措施

Single-Level Radiofrequency Ablation

Active Comparator

Participants in this arm will undergo fluoroscopy-guided single-level radiofrequency ablation of the ganglion impar using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists.

干预措施: Single-Level Ganglion Impar Radiofrequency Ablation (Procedure)

Double-Level Radiofrequency Ablation

Active Comparator

Participants in this arm will undergo fluoroscopy-guided double-level radiofrequency ablation of the ganglion impar, targeting two adjacent levels using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists.

干预措施: Double-Level Ganglion Impar Radiofrequency Ablation (Procedure)

结局指标

主要结局

Change in pain intensity (Numeric Rating Scale, NRS)

时间窗: Baseline, 1 hour, 3 weeks, and 2 months post-procedure

Pain intensity will be assessed using the Numeric Rating Scale (NRS), a self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes in pain scores from baseline will be evaluated at 1 hour, 3 weeks, and 2 months after the procedure. Higher scores indicate worse pain intensity.

次要结局

  • Quality of life (EuroQol-5D-3L, EQ-5D-3L)(Baseline, 3 weeks, and 2 months post-procedure)
  • Functional status (Paris Coccydynia Questionnaire)(Baseline, 3 weeks, and 2 months post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haner Direskeneli

Professor, MD

Marmara University

研究点 (1)

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