Comparison of Ganglion Impar Radiofrequency Ablation and Phenol Neurolysis Techniques for Chronic Coccydynia Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Phenol Injection

    Drug

    n 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

    Device

    In 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

30 Participants
are divided into 2 treatment groups
Group A: Ganglion Impar Radiofrequency AblationActive comparator 1 intervention
Group B: Ganglion Impar Phenol NeurolysisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Rating Scale-11

A subjective outcome measure to assess pain (Min:0 Max:10). Higher scores indicate more severe pain.

Time frame
Treatment to 6 months post-treatment

Secondary outcomes

1

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.

Time frame
Treatment to 6 months post-treatment.
2

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.

Time frame
Treatment to 6 months post-treatment.

Other outcomes

Sponsors and contacts

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