Marmara University Faculty of Medicine
Istanbul, PENDİK, 34899, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07509593
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Istanbul, PENDİK, 34899, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Marmara University
Other
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