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NCT Number: NCT07509593

Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Medicine

Istanbul, PENDİK, 34899, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gaye Boztepe

CONTACT

[email protected]

+90 2166254545

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-Level Ganglion Impar Radiofrequency Ablation

Procedure

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.

Double-Level Ganglion Impar Radiofrequency Ablation

Procedure

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.

Primary outcomes

  1. Change in pain intensity (Numeric Rating Scale, NRS)

    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.

Secondary outcomes

  1. Quality of life (EuroQol-5D-3L, EQ-5D-3L)

    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.

  2. Functional status (Paris Coccydynia Questionnaire)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gaye Boztepe, MD

CONTACT

[email protected]

+902166254545

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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