Chronic Coccydynia
Conditions
Keywords
Chronic coccydynia, Ganglion impar, Radiofrequency ablation, Interventional pain management
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.
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.
Interventions
PROCEDURESingle-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.
PROCEDUREDouble-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.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (Numeric Rating Scale, NRS) | Baseline, 1 hour, 3 weeks, and 2 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EuroQol-5D-3L, EQ-5D-3L) | Baseline, 3 weeks, and 2 months post-procedure | Quality of life will be assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire, which includes a descriptive system and a visual analog scale. The EQ-5D-3L index value typically ranges from less than 0 (health states worse than death) to 1 (perfect health). Changes from baseline will be evaluated at follow-up time points. Higher scores indicate better health-related quality of life. |
| Functional status (Paris Coccydynia Questionnaire) | Baseline, 3 weeks, and 2 months post-procedure | Functional status and the impact on daily living will be assessed using the Paris Coccydynia Questionnaire before and after radiofrequency ablation. Changes from baseline will be evaluated. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGaye Boztepe, MD
Outcome results
None listed