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

NCT07509593 | Recruiting

• 1 other identifier: 09.2026.718
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Coccydynia

Keywords

Chronic coccydynia; Ganglion impar; Radiofrequency ablation; Interventional pain management

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity (Numeric Rating Scale, NRS)

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Procedure: Single-Level Ganglion Impar Radiofrequency Ablation

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.

Procedure: Double-Level Ganglion Impar Radiofrequency Ablation

Interventions

Single-Level Ganglion Impar Radiofrequency Ablation PROCEDURE

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.

Single-Level Radiofrequency Ablation

Double-Level Ganglion Impar Radiofrequency Ablation PROCEDURE

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.

Double-Level Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine

Istanbul, PENDİK, 34899, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Gaye Boztepe, MD

CONTACT

+902166254545; gayeboztepe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: single-level or double-level radiofrequency ablation of the ganglion impar. Each participant will receive only one assigned intervention, and outcomes will be assessed and compared between groups over the follow-up period.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TU (1)