Ganglion Impar vs Coccygeal Nerve Radiofrequency Ablation in Chronic Coccydynia

NCT07427212 | Completed

• 1 other identifier: GULHANE-ALG-COCCY-RF-2025-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Coccydynia

Keywords

Chronic coccydynia Ganglion impar Coccygeal nerve

Outcome Measures

Primary Outcomes (1)

• Pain reduction at 3 months

  Pain intensity was assessed using the Numeric Rating Scale (NRS). The primary outcome was defined as the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline.

  3 months

Secondary Outcomes (3)

• Functional improvement at 3 months

  3 months

• Change in pain intensity over time

  Baseline, 3 weeks, and 3 months

• Procedure-related complications

  Up to 3 months

Study Arms (2)

Ganglion Impar Radiofrequency Ablation

EXPERIMENTAL

Participants underwent fluoroscopy-guided ganglion impar thermal radiofrequency ablation.

Procedure: Ganglion impar radiofrequency ablation

Coccygeal Nerve Radiofrequency Ablation

EXPERIMENTAL

Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques.

Procedure: Coccygeal nerve radiofrequency ablation

Interventions

Ganglion impar radiofrequency ablation PROCEDURE

Thermal radiofrequency ablation of the ganglion impar performed under fluoroscopic guidance using standard interventional pain management techniques.

Ganglion Impar Radiofrequency Ablation

Coccygeal nerve radiofrequency ablation PROCEDURE

Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques.

Coccygeal Nerve 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:

• Adults aged 18 to 75 years Diagnosis of chronic coccydynia lasting longer than 3 months Numeric Rating Scale (NRS) score ≥ 4 at baseline Inadequate response to conservative medical treatment Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• Acute coccygeal fracture or recent trauma Local or systemic infection Known malignancy involving the pelvic or sacrococcygeal region Coagulation disorders or ongoing anticoagulant therapy that cannot be safely discontinued Known allergy to local anesthetics or materials used in the procedure Severe psychiatric disorders or cognitive impairment interfering with study participation Pregnancy or breastfeeding

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology,

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

Related Publications (5)

• Genc Perdecioglu GR, Yildiz G. Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial. Cureus. 2024;16(9):e69118.

  BACKGROUND

• Can E, Yildiz G, Akkaya OT, et al. Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation and Steroid Injection: Combination Therapy for Coccydynia. J Ultrasound Med. 2024;43(1):57-64.

  BACKGROUND

• Choudhary R, et al. Improvement in pain following ganglion impar blocks and radiofrequency ablation in coccygodynia patients: a systematic review. Rev Bras Ortop (Sao Paulo). 2021;56(5):558-566.

  BACKGROUND

• Elkhashab Y, Ng A. A review of current treatment options for coccygodynia. Curr Pain Headache Rep. 2018;22(4):28.

  BACKGROUND

• Patijn J, Janssen M, Hayek S, Mekhail N, Van Zundert J. Coccygodynia. Pain Pract. 2010;10(6):554-559.

  RESULT

Study Officials

• ALP E Çelenlioğlu, MD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: November 11, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 months after publication
• Access Criteria: Access to de-identified individual participant data and supporting documents, including the study protocol and statistical analysis plan, will be granted to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and must include a methodologically sound proposal. Data sharing will be conducted in accordance with institutional policies and applicable data protection regulations.

Locations

TU (1)