Chronic CoccydyniaNCT07509593
Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia
A study testing Single-Level Ganglion Impar Radiofrequency Ablation and Double-Level Ganglion Impar Radiofrequency Ablation in people with Chronic Coccydynia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Coccydynia
- What is being tested?
- Single-Level Ganglion Impar Radiofrequency Ablation and Double-Level Ganglion Impar Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Faculty of Medicine
Istanbul, PENDİK, 34899
Gaye Boztepe, +90 2166254545, gayeboztepe@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Coccydynia
- Being tested
- Single-Level Ganglion Impar Radiofrequency Ablation, Double-Level Ganglion Impar Radiofrequency Ablation
- Keywords
- Chronic coccydynia, Ganglion impar, Radiofrequency ablation, Interventional pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Level Ganglion Impar Radiofrequency AblationProcedure or surgery
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 AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Level Radiofrequency Ablation | Active comparator | Participants in this arm will undergo fluoroscopy-guided single-level radiofrequency ablation of the ganglion impar using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists. Receives: Procedure: Single-Level Ganglion Impar Radiofrequency Ablation |
| Double-Level Radiofrequency Ablation | Active comparator | Participants in this arm will undergo fluoroscopy-guided double-level radiofrequency ablation of the ganglion impar, targeting two adjacent levels using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists. Receives: Procedure: Double-Level Ganglion Impar Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 hour, 3 weeks, and 2 months post-procedure
Secondary outcomes (2)
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.
Measured: Baseline, 3 weeks, and 2 months post-procedure
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.
Measured: Baseline, 3 weeks, and 2 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoccydyniaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: single-level or double-level radiofrequency ablation of the ganglion impar. Each participant will receive only one assigned intervention, and outcomes will be assessed and compared between groups over the follow-up period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509593
- Sponsor's protocol ID
- 09.2026.718
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia
- ClinicalTrials.gov ID
- NCT07509593
- Acronym / sponsor ID
- 09.2026.718
- Conditions
- Chronic Coccydynia
- Keywords
- Chronic coccydynia, Ganglion impar, Radiofrequency ablation, Interventional pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: single-level or double-level radiofrequency ablation of the ganglion impar. Each participant will receive only one assigned intervention, and outcomes will be assessed and compared between groups over the follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Single-Level Radiofrequency Ablation | Active comparator | Procedure: Single-Level Ganglion Impar Radiofrequency AblationParticipants in this arm will undergo fluoroscopy-guided single-level radiofrequency ablation of the ganglion impar using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists. |
| Double-Level Radiofrequency Ablation | Active comparator | Procedure: Double-Level Ganglion Impar Radiofrequency AblationParticipants in this arm will undergo fluoroscopy-guided double-level radiofrequency ablation of the ganglion impar, targeting two adjacent levels using a standardized technique. The procedure will be performed under sterile conditions by experienced pain specialists. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Level Ganglion Impar Radiofrequency AblationFluoroscopy-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. | Procedure or surgery | Single-Level Radiofrequency Ablation |
| Double-Level Ganglion Impar Radiofrequency AblationFluoroscopy-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. | Procedure or surgery | Double-Level Radiofrequency Ablation |
Primary outcome
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.
2 secondary outcomes
Quality of life (EuroQol-5D-3L, EQ-5D-3L)
Time frame: Baseline, 3 weeks, and 2 months post-procedure
Functional status (Paris Coccydynia Questionnaire)
Time frame: Baseline, 3 weeks, and 2 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Level Ganglion Impar Radiofrequency Ablation and Double-Level Ganglion Impar Radiofrequency Ablation in people with Chronic Coccydynia, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaye Boztepe, MD (+902166254545, gayeboztepe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Numeric Rating Scale, NRS) (time frame: Baseline, 1 hour, 3 weeks, and 2 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.