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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganglion Impar Radiofrequency Ablation | Experimental | Participants underwent fluoroscopy-guided ganglion impar thermal radiofrequency ablation. |
|
| Coccygeal Nerve Radiofrequency Ablation | Experimental | Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganglion impar radiofrequency ablation | Procedure | Thermal radiofrequency ablation of the ganglion impar performed under fluoroscopic guidance using standard interventional pain management techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement at 3 months | Functional disability was evaluated using the modified Oswestry Disability Index (MODI). A reduction of at least 50% in MODI score at 3 months compared with baseline was assessed. | 3 months |
| Change in pain intensity over time |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| ALP E Çelenlioğlu, MD | Saglik Bilimleri Universitesi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, | Ankara | Etlik | 06010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39398734 | Background | Genc Perdecioglu GR, Yildiz G. Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial. Cureus. 2024 Sep 10;16(9):e69118. doi: 10.7759/cureus.69118. eCollection 2024 Sep. | |
| 37706553 | Background | Can E, Yildiz G, Akkaya OT, Perdecioglu GRG, Yuruk D. Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation and Steroid Injection: Combination Therapy for Coccydynia. J Ultrasound Med. 2024 Jan;43(1):57-64. doi: 10.1002/jum.16334. Epub 2023 Sep 14. |
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De-identified individual participant data underlying the results reported in the published article.
3 months after publication
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.
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| Coccygeal nerve radiofrequency ablation | Procedure | Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques. |
|
Changes in pain intensity were assessed using the Numeric Rating Scale (NRS) at baseline, 3 weeks, and 3 months after the procedure. |
| Baseline, 3 weeks, and 3 months |
| Procedure-related complications | The incidence of procedure-related adverse events and complications was recorded throughout the follow-up period. | Up to 3 months |
| 34733426 | Background | Choudhary R, Kunal K, Kumar D, Nagaraju V, Verma S. Improvement in Pain Following Ganglion Impar Blocks and Radiofrequency Ablation in Coccygodynia Patients: A Systematic Review. Rev Bras Ortop (Sao Paulo). 2021 Oct 28;56(5):558-566. doi: 10.1055/s-0041-1735829. eCollection 2021 Oct. |
| 29556817 | Background | Elkhashab Y, Ng A. A Review of Current Treatment Options for Coccygodynia. Curr Pain Headache Rep. 2018 Mar 19;22(4):28. doi: 10.1007/s11916-018-0683-7. |
| 20825565 | Result | Patijn J, Janssen M, Hayek S, Mekhail N, Van Zundert J, van Kleef M. 14. Coccygodynia. Pain Pract. 2010 Nov-Dec;10(6):554-9. doi: 10.1111/j.1533-2500.2010.00404.x. Epub 2010 Sep 6. |