Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia
ConditionChronic Coccydynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Single-Level Ganglion Impar Radiofrequency Ablation
Procedure/SurgeryFluoroscopy-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.
Double-Level Ganglion Impar Radiofrequency Ablation
Procedure/SurgeryFluoroscopy-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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Single-Level Radiofrequency AblationActive comparator 1 intervention
Group B: Double-Level Radiofrequency AblationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 1 hour, 3 weeks, and 2 months post-procedureSecondary outcomes
1
Quality of life (EuroQol-5D-3L, EQ-5D-3L)
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-procedure2
Functional status (Paris Coccydynia Questionnaire)
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.
Time frame
Baseline, 3 weeks, and 2 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov