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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Single-Level Ganglion Impar Radiofrequency Ablation
  Fluoroscopy-guided radiofrequency ablation of the ganglion impar will be performed using a transsacrococcygeal approach. After appropriate needle placement and confirmation, thermal radiofrequency lesioning will be applied at a single level using standardized parameters.
• Процедура Double-Level Ganglion Impar Radiofrequency Ablation
  Fluoroscopy-guided radiofrequency ablation of the ganglion impar will be performed using a combined transsacrococcygeal and transcoccygeal approach. After appropriate needle placement and confirmation, thermal radiofrequency lesioning will be applied at two adjacent levels using standardized parameters.

Первичные конечные точки

• Change in pain intensity (Numeric Rating Scale, NRS) [Срок оценки: Baseline, 1 hour, 3 weeks, and 2 months post-procedure]

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University Faculty of Medicine — Istanbul

Идентификаторы

NCT: NCT07509593 · 09.2026.718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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