NCT07509593

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare two commonly used radiofrequency ablation techniques for the treatment of chronic tailbone (coccyx) pain. Chronic coccydynia can significantly affect daily activities and quality of life, especially 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 procedure targeting the coccygeal nerves. These procedures are minimally invasive and are routinely performed in pain management clinics. The goal of the study is to determine which technique provides better pain relief and functional improvement. Patients will be followed for up to two months after the procedure, and pain levels and quality of life will be evaluated. The results of this study may help improve treatment strategies for patients suffering from chronic coccydynia.

Detailed description

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.

Conditions

• Chronic Coccydynia

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2026-04-03
• Last updated: 2026-04-03