NCT07427212

Ganglion Impar vs Coccygeal Nerve Radiofrequency Ablation in Chronic Coccydynia

Comparison of Fluoroscopy-Guided Ganglion Impar and Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation in Patients With Chronic Coccydynia: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that significantly affects daily activities and quality of life. When conservative treatments fail, interventional pain procedures such as radiofrequency ablation may be considered. This single-center, prospective, randomized study compared two radiofrequency ablation techniques used in the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar radiofrequency ablation and ultrasound-guided coccygeal nerve radiofrequency ablation. Adult patients with chronic coccydynia who did not respond to medical treatment were randomly assigned to receive one of these two interventions. Pain intensity and functional disability were evaluated using standardized assessment tools before the procedure and during follow-up visits at 3 weeks and 3 months after treatment. The primary objective was to compare pain relief between the two techniques at 3 months. Secondary objectives included evaluation of functional improvement and procedure-related complications. The results of this study provide comparative information on the effectiveness and safety of these two commonly used radiofrequency techniques and may help guide clinicians in selecting appropriate interventional treatments for patients with chronic coccydynia.

Detailed description

This study was designed as a single-center, prospective, randomized clinical trial to compare two radiofrequency ablation techniques used for the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar thermal radiofrequency ablation and ultrasound-guided coccygeal nerve thermal radiofrequency ablation.Adult patients with chronic coccydynia persisting for more than three months and refractory to conservative medical management were evaluated for eligibility. Following informed consent, eligible participants were randomly assigned in a 1:1 ratio to undergo either ganglion impar radiofrequency ablation or coccygeal nerve radiofrequency ablation. Randomization was performed prior to the intervention.All procedures were conducted under standard sterile conditions by experienced pain physicians. Ganglion impar radiofrequency ablation was performed under fluoroscopic guidance, while coccygeal nerve radiofrequency ablation was performed under ultrasound guidance. Both interventions followed established clinical protocols routinely used in interventional pain practice. Pain intensity was assessed using the Numeric Rating Scale (NRS), and functional status was evaluated using the modified Oswestry Disability Index (MODI). Assessments were conducted at baseline prior to the procedure and during follow-up visits at 3 weeks and 3 months after treatment. Adverse events and procedure-related complications were monitored and recorded throughout the follow-up period. The primary outcome measure was the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline. Secondary outcome measures included changes in MODI scores at 3 months and the incidence of procedure-related complications. The study protocol was approved by the local ethics committee, and the study was conducted in accordance with the principles of the Declaration of Helsinki.

Conditions

• Chronic Coccydynia

Interventions

Type	Name	Description
PROCEDURE	Ganglion impar radiofrequency ablation	Thermal radiofrequency ablation of the ganglion impar performed under fluoroscopic guidance using standard interventional pain management techniques.
PROCEDURE	Coccygeal nerve radiofrequency ablation	Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques.

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Turkey (Türkiye)