About this trial
Radiofrequency ablation and phenol neurolysis of the ganglion impar are methods used in cases unresponsive to medication, particularly in patients who derive short-term or partial relief from the initial ganglion impar block. In clinical practice, clinicians frequently use these two injections in patients with treatment-resistant pain who only partially benefit from the initial blockade procedure.
To date, the medical literature lacks a comprehensive study comparing the efficacy of radiofrequency ablation and phenol neurolysis in patients who partially benefit from ganglion impar block. Therefore, this study is designed to compare the effectiveness of these two methods in patients with chronic coccydynia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years
Presence of chronic coccydynia lasting at least 3 months
Pre-procedural pain score of 4 or higher on the Numeric Rating Scale (NRS)
Patients who have undergone a ganglion impar block within the last 3 months and experienced limited benefit (i.e., less than 50% reduction in pain compared to pre-treatment) and/or short-term relief (less than 4 weeks)
Disqualifiers
History of surgery involving the sacrococcygeal region
Prior treatment with ganglion impar phenol neurolysis or radiofrequency ablation
Coagulopathies (bleeding disorders)
Infection
Trial design
Parallel
Treatments tested in this trial
Phenol Injection
Drugn patients diagnosed with chronic coccydynia, a ganglion impar block is initially performed following conservative treatment. In cases where this intervention provides limited benefit, ganglion impar phenol neurolysis is performed. A short-acting local anesthetic (3-4 mL of 1% prilocaine) will be administered into the skin and subcutaneous tissues. A 90 mm 22-gauge Quincke-tipped spinal needle will be advanced via the trans-coccygeal route under fluoroscopic guidance with intermittent imaging. The needle's position in the area anterior to the coccyx, where the ganglion impar is located, will be confirmed using 1-2 mL of contrast agent (iohexol). If the desired spread of contrast is observed, 5 mL of 7% phenol will be injected.
Radiofrequency ablation alone
DeviceIn patients diagnosed with chronic coccydynia, a ganglion impar block is initially performed following conservative treatment. In cases where this intervention provides limited benefit, ganglion impar radiofrequency (RF) ablation-routinely used in clinical practice-will be performed by an experienced pain specialist (SŞ) with at least 10 years of expertise in this procedure. Using fluoroscopic guidance and intermittent imaging, a 100 mm RF cannula with an injection tube will be advanced trans-coccygeally. After confirming the needle's position at the site of the ganglion impar in front of the coccyx with 1-2 mL of contrast agent (iohexol), sensory stimulation will be applied via the RF generator to confirm that the needle tip is at the patient's pain site. Motor stimulation will also be performed to ensure there is no muscle contraction. At this stage, 2 mL of lidocaine will be administered before initiating ablation at 80°C for 90 seconds.
Treatment groups
Trial outcomes
Primary outcomes
Numeric Rating Scale-11
A subjective outcome measure to assess pain (Min:0 Max:10). Higher scores indicate more severe pain.
Secondary outcomes
Short Form-12 Health Survey
The SF-12 (Short Form-12 Health Survey) is a validated instrument used to evaluate health-related quality of life, with scores ranging from 0 to 100. Higher scores reflect better overall health status.
Douleur Neuropathique 4
The DN4 (Douleur Neuropathique 4) questionnaire is a diagnostic screening tool designed to detect the presence of neuropathic pain, with scores ranging from 1 to 10. Higher scores suggest a greater probability of neuropathic pain.
Sponsors and contacts
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