Chronic CoccydyniaNCT07427212
Ganglion Impar vs Coccygeal Nerve Radiofrequency Ablation in Chronic Coccydynia
A study testing Ganglion impar radiofrequency ablation and Coccygeal nerve radiofrequency ablation in people with Chronic Coccydynia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that significantly affects daily activities and quality of life. When conservative treatments fail, interventional pain procedures such as radiofrequency ablation may be considered. 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?
- Ganglion impar radiofrequency ablation and Coccygeal nerve 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
- 11 Nov 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 to 75 years Diagnosis of chronic coccydynia lasting longer than 3 months Numeric Rating Scale (NRS) score ≥ 4 at baseline Inadequate response to conservative medical treatment Ability to understand the study procedures and provide written informed consent
Who cannot join
- Acute coccygeal fracture or recent trauma Local or systemic infection Known malignancy involving the pelvic or sacrococcygeal region Coagulation disorders or ongoing anticoagulant therapy that cannot be safely discontinued Known allergy to local anesthetics or materials used in the procedure Severe psychiatric disorders or cognitive impairment interfering with study participation Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology,
Ankara, Etlik, 06010
About this study
Official title: Comparison of Fluoroscopy-Guided Ganglion Impar and Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation in Patients With Chronic Coccydynia: A Prospective Randomized Study
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that significantly affects daily activities and quality of life. When conservative treatments fail, interventional pain procedures such as radiofrequency ablation may be considered.
This single-center, prospective, randomized study compared two radiofrequency ablation techniques used in the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar radiofrequency ablation and ultrasound-guided coccygeal nerve radiofrequency ablation. Adult patients with chronic coccydynia who did not respond to medical treatment were randomly assigned to receive one of these two interventions. Pain intensity and functional disability were evaluated using standardized assessment tools before the procedure and during follow-up visits at 3 weeks and 3 months after treatment. The primary objective was to compare pain relief between the two techniques at 3 months. Secondary objectives included evaluation of functional improvement and procedure-related complications. The results of this study provide comparative information on the effectiveness and safety of these two commonly used radiofrequency techniques and may help guide clinicians in selecting appropriate interventional treatments for patients with chronic coccydynia.
Read the detailed description
This study was designed as a single-center, prospective, randomized clinical trial to compare two radiofrequency ablation techniques used for the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar thermal radiofrequency ablation and ultrasound-guided coccygeal nerve thermal radiofrequency ablation.Adult patients with chronic coccydynia persisting for more than three months and refractory to conservative medical management were evaluated for eligibility. Following informed consent, eligible participants were randomly assigned in a 1:1 ratio to undergo either ganglion impar radiofrequency ablation or coccygeal nerve radiofrequency ablation. Randomization was performed prior to the intervention.All procedures were conducted under standard sterile conditions by experienced pain physicians. Ganglion impar radiofrequency ablation was performed under fluoroscopic guidance, while coccygeal nerve radiofrequency ablation was performed under ultrasound guidance. Both interventions followed established clinical protocols routinely used in interventional pain practice. Pain intensity was assessed using the Numeric Rating Scale (NRS), and functional status was evaluated using the modified Oswestry Disability Index (MODI). Assessments were conducted at baseline prior to the procedure and during follow-up visits at 3 weeks and 3 months after treatment. Adverse events and procedure-related complications were monitored and recorded throughout the follow-up period. The primary outcome measure was the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline. Secondary outcome measures included changes in MODI scores at 3 months and the incidence of procedure-related complications. The study protocol was approved by the local ethics committee, and the study was conducted in accordance with the principles of the Declaration of Helsinki.
- Conditions
- Chronic Coccydynia
- Being tested
- Ganglion impar radiofrequency ablation, Coccygeal nerve radiofrequency ablation
- Keywords
- Chronic coccydynia Ganglion impar Coccygeal nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglion impar radiofrequency ablationProcedure or surgery
Thermal radiofrequency ablation of the ganglion impar performed under fluoroscopic guidance using standard interventional pain management techniques.
Coccygeal nerve radiofrequency ablationProcedure or surgery
Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques.
| Study group | Role | What they receive |
|---|---|---|
| Ganglion Impar Radiofrequency Ablation | Experimental | Participants underwent fluoroscopy-guided ganglion impar thermal radiofrequency ablation. Receives: Procedure: Ganglion impar radiofrequency ablation |
| Coccygeal Nerve Radiofrequency Ablation | Experimental | Thermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques. Receives: Procedure: Coccygeal nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction at 3 months
Pain intensity was assessed using the Numeric Rating Scale (NRS). The primary outcome was defined as the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline.
Measured: 3 months
Secondary outcomes (3)
Functional improvement at 3 months
Functional disability was evaluated using the modified Oswestry Disability Index (MODI). A reduction of at least 50% in MODI score at 3 months compared with baseline was assessed.
Measured: 3 months
Change in pain intensity over time
Changes in pain intensity were assessed using the Numeric Rating Scale (NRS) at baseline, 3 weeks, and 3 months after the procedure.
Measured: Baseline, 3 weeks, and 3 months
Procedure-related complications
The incidence of procedure-related adverse events and complications was recorded throughout the follow-up period.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start11 Nov 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic CoccydyniaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALP E Çelenlioğlu, MD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427212
- Sponsor's protocol ID
- GULHANE-ALG-COCCY-RF-2025-01
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article.
Publications
Genc Perdecioglu GR, Yildiz G. Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial. Cureus. 2024 Sep 10;16(9):e69118. doi: 10.7759/cureus.69118. eCollection 2024 Sep.
PubMed 39398734Can E, Yildiz G, Akkaya OT, Perdecioglu GRG, Yuruk D. Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation and Steroid Injection: Combination Therapy for Coccydynia. J Ultrasound Med. 2024 Jan;43(1):57-64. doi: 10.1002/jum.16334. Epub 2023 Sep 14.
PubMed 37706553Choudhary R, Kunal K, Kumar D, Nagaraju V, Verma S. Improvement in Pain Following Ganglion Impar Blocks and Radiofrequency Ablation in Coccygodynia Patients: A Systematic Review. Rev Bras Ortop (Sao Paulo). 2021 Oct 28;56(5):558-566. doi: 10.1055/s-0041-1735829. eCollection 2021 Oct.
PubMed 34733426Elkhashab Y, Ng A. A Review of Current Treatment Options for Coccygodynia. Curr Pain Headache Rep. 2018 Mar 19;22(4):28. doi: 10.1007/s11916-018-0683-7.
PubMed 29556817Patijn J, Janssen M, Hayek S, Mekhail N, Van Zundert J, van Kleef M. 14. Coccygodynia. Pain Pract. 2010 Nov-Dec;10(6):554-9. doi: 10.1111/j.1533-2500.2010.00404.x. Epub 2010 Sep 6.
PubMed 20825565
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fluoroscopy-Guided Ganglion Impar and Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation in Patients With Chronic Coccydynia: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07427212
- Acronym / sponsor ID
- GULHANE-ALG-COCCY-RF-2025-01
- Conditions
- Chronic Coccydynia
- Keywords
- Chronic coccydynia Ganglion impar Coccygeal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Feb 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.
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that significantly affects daily activities and quality of life. When conservative treatments fail, interventional pain procedures such as radiofrequency ablation may be considered.
This single-center, prospective, randomized study compared two radiofrequency ablation techniques used in the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar radiofrequency ablation and ultrasound-guided coccygeal nerve radiofrequency ablation. Adult patients with chronic coccydynia who did not respond to medical treatment were randomly assigned to receive one of these two interventions. Pain intensity and functional disability were evaluated using standardized assessment tools before the procedure and during follow-up visits at 3 weeks and 3 months after treatment. The primary objective was to compare pain relief between the two techniques at 3 months. Secondary objectives included evaluation of functional improvement and procedure-related complications. The results of this study provide comparative information on the effectiveness and safety of these two commonly used radiofrequency techniques and may help guide clinicians in selecting appropriate interventional treatments for patients with chronic coccydynia.
Detailed description
This study was designed as a single-center, prospective, randomized clinical trial to compare two radiofrequency ablation techniques used for the treatment of chronic coccydynia: fluoroscopy-guided ganglion impar thermal radiofrequency ablation and ultrasound-guided coccygeal nerve thermal radiofrequency ablation.Adult patients with chronic coccydynia persisting for more than three months and refractory to conservative medical management were evaluated for eligibility. Following informed consent, eligible participants were randomly assigned in a 1:1 ratio to undergo either ganglion impar radiofrequency ablation or coccygeal nerve radiofrequency ablation. Randomization was performed prior to the intervention.All procedures were conducted under standard sterile conditions by experienced pain physicians. Ganglion impar radiofrequency ablation was performed under fluoroscopic guidance, while coccygeal nerve radiofrequency ablation was performed under ultrasound guidance. Both interventions followed established clinical protocols routinely used in interventional pain practice. Pain intensity was assessed using the Numeric Rating Scale (NRS), and functional status was evaluated using the modified Oswestry Disability Index (MODI). Assessments were conducted at baseline prior to the procedure and during follow-up visits at 3 weeks and 3 months after treatment. Adverse events and procedure-related complications were monitored and recorded throughout the follow-up period. The primary outcome measure was the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline. Secondary outcome measures included changes in MODI scores at 3 months and the incidence of procedure-related complications. The study protocol was approved by the local ethics committee, and the study was conducted in accordance with the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganglion Impar Radiofrequency Ablation | Experimental | Procedure: Ganglion impar radiofrequency ablationParticipants underwent fluoroscopy-guided ganglion impar thermal radiofrequency ablation. |
| Coccygeal Nerve Radiofrequency Ablation | Experimental | Procedure: Coccygeal nerve radiofrequency ablationThermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 75 years Diagnosis of chronic coccydynia lasting longer than 3 months Numeric Rating Scale (NRS) score ≥ 4 at baseline Inadequate response to conservative medical treatment Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (1 listed)
- Acute coccygeal fracture or recent trauma Local or systemic infection Known malignancy involving the pelvic or sacrococcygeal region Coagulation disorders or ongoing anticoagulant therapy that cannot be safely discontinued Known allergy to local anesthetics or materials used in the procedure Severe psychiatric disorders or cognitive impairment interfering with study participation Pregnancy or breastfeeding
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 |
|---|---|---|
| Ganglion impar radiofrequency ablationThermal radiofrequency ablation of the ganglion impar performed under fluoroscopic guidance using standard interventional pain management techniques. | Procedure or surgery | Ganglion Impar Radiofrequency Ablation |
| Coccygeal nerve radiofrequency ablationThermal radiofrequency ablation of the coccygeal nerve performed under ultrasound guidance using standard interventional pain management techniques. | Procedure or surgery | Coccygeal Nerve Radiofrequency Ablation |
Primary outcome
Pain reduction at 3 months
Time frame: 3 months
Pain intensity was assessed using the Numeric Rating Scale (NRS). The primary outcome was defined as the proportion of patients achieving at least a 50% reduction in NRS score at 3 months compared with baseline.
3 secondary outcomes
Functional improvement at 3 months
Time frame: 3 months
Change in pain intensity over time
Time frame: Baseline, 3 weeks, and 3 months
Procedure-related complications
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 39398734Genc Perdecioglu GR, Yildiz G. Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial. Cureus. 2024 Sep 10;16(9):e69118. doi: 10.7759/cureus.69118. eCollection 2024 Sep.
- Background: PubMed 37706553Can E, Yildiz G, Akkaya OT, Perdecioglu GRG, Yuruk D. Ultrasound-Guided Coccygeal Nerve Radiofrequency Ablation and Steroid Injection: Combination Therapy for Coccydynia. J Ultrasound Med. 2024 Jan;43(1):57-64. doi: 10.1002/jum.16334. Epub 2023 Sep 14.
- Background: PubMed 34733426Choudhary R, Kunal K, Kumar D, Nagaraju V, Verma S. Improvement in Pain Following Ganglion Impar Blocks and Radiofrequency Ablation in Coccygodynia Patients: A Systematic Review. Rev Bras Ortop (Sao Paulo). 2021 Oct 28;56(5):558-566. doi: 10.1055/s-0041-1735829. eCollection 2021 Oct.
- Background: PubMed 29556817Elkhashab Y, Ng A. A Review of Current Treatment Options for Coccygodynia. Curr Pain Headache Rep. 2018 Mar 19;22(4):28. doi: 10.1007/s11916-018-0683-7.
- Results publication: PubMed 20825565Patijn J, Janssen M, Hayek S, Mekhail N, Van Zundert J, van Kleef M. 14. Coccygodynia. Pain Pract. 2010 Nov-Dec;10(6):554-9. doi: 10.1111/j.1533-2500.2010.00404.x. Epub 2010 Sep 6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article.
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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. This study is not recruiting at the moment.
ALP E Çelenlioğlu, MD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganglion impar radiofrequency ablation and Coccygeal nerve radiofrequency ablation in people with Chronic Coccydynia, run by Saglik Bilimleri Universitesi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427212, which also lists 5 linked publications.
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 23 Feb 2026.