Caudal Epidural BlockNCT07200765
Efficacy of Combining Caudal Epidural Steroid With Ganglion Impar Block in Chronic Coccydynia
An observational study of Caudal Epidural Block and Coccygodynia, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Coccydynia refers to pain localized to the tailbone (coccygeal) region. Initial management is conservative-nonsteroidal anti-inflammatory drugs (NSAIDs), use of a seat cushion, and physical therapy-yet a proportion of patients remain symptomatic and subsequently pursue interventional options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caudal Epidural Block, Coccygodynia, Coccydynia
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Nov 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults with chronic coccydynia who received either a ganglion impar block (GIB) alone or a combined with caudal epidural steroid injection as part of routine clinical care at the Algology Clinic of Mersin University Hospital between January 1, 2020, and May 20, 2025. Patients were not assigned to treatments by protocol; intervention choice reflected clinician judgment and patient characteristics. Outcomes (e.g., NRS-11 pain scores) were abstracted from medical records at baseline and follow-up.
Who may be able to join
- Age ≥18 years
- Chronic coccydynia >3 months
- Inadequate response to conservative treatments
- Written informed consent documented for the procedure (per records)
Who cannot join
- Active infection on the injection date.
- History of lumbar or coccygeal surgery
- Allergy to local anesthetics or contrast media
- Coagulopathy / anticoagulant therapy contraindicating the procedure
- Inadequate follow-up documentation
- Injection performed to a different region during the indexed procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Department of Algology
Mersin, Mersin, 33110
About this study
Official title: Is the Combination of Ganglion Impar Block and Caudal Epidural Steroid Injection Superior to Ganglion Impar Block Alone in Chronic Coccydynia? A Retrospective Study
Coccydynia refers to pain localized to the tailbone (coccygeal) region. Initial management is conservative-nonsteroidal anti-inflammatory drugs (NSAIDs), use of a seat cushion, and physical therapy-yet a proportion of patients remain symptomatic and subsequently pursue interventional options. The ganglion impar block (GIB), originally used to treat perineal cancer pain, is now recognized as an effective approach for perineal and coccygeal pain of both malignant and benign etiologies. Caudal epidural steroid injection (CESI) is also employed, either as monotherapy or in conjunction with other treatments; however, its precise role in coccydynia has not been clearly defined. Evidence directly comparing these injections is limited, and whether the combination confers superiority over GIB alone remains unresolved.
In this retrospective study, we will compare GIB alone versus GIB combined with CESI in adults treated for chronic coccydynia refractory to noninterventional management and evaluate any incremental benefit of the combination.
Read the detailed description
Coccydynia refers to pain localized to the coccygeal region that commonly intensifies with sitting and forward flexion. It frequently follows a fall or direct trauma and can constrain routine activities. The majority of patients respond to conservative management, including rest, use of a seat cushion, physical therapy, nonsteroidal anti-inflammatory agents, and lifestyle modification. For patients who remain symptomatic, a fluoroscopy-guided ganglion impar block can alleviate pain by modulating sympathetic pathways. The procedure is usually well tolerated; reported complications include infection, bleeding, and, rarely, rectal perforation.
Caudal epidural steroid injection (CESI), administered via the sacral canal, is an adjunctive option used to mitigate inflammation in the lumbosacral region. In selected patients, combining CESI with a ganglion impar block may enhance analgesic control by attenuating inflammation and sympathetic input.
In this retrospective cohort study, the comparative effectiveness of two injection strategies (GIB alone and GIB plus CESI) will be evaluated in adults with chronic coccydynia.
The medical records of patients who presented to the Algology Outpatient Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2020, and May 20, 2025, with chronic coccydynia and who underwent a ganglion impar block will be evaluated in a retrospective review. A minimum target sample size of 50 patients is planned. All included patients had previously received conservative treatment without clinical benefit. Patients were excluded if, at the time of injection, they had an active infection; a history of lumbar or coccygeal surgery; a documented hypersensitivity to local anesthetics or iodinated contrast agents; or a bleeding diathesis. Data collected: age, sex, trauma history, NRS-11 scores pre-procedure, 1 hour, 1 month and 6 month post-procedure.
The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach. The injectate volume was 5 mL, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride.
The caudal epidural steroid injection (CESI) was performed under fluoroscopic guidance with both lateral and anteroposterior views. A total of 5 mL was administered, comprising 40 mg methylprednisolone acetate diluted in 4 mL normal saline.
Outcome measures included:
Primary: Pain relief measured using a Numerical Rating Scale (NRS) at baseline and 6 months post-procedure.
Secondary: Change in NRS-11 pain score from baseline to 1 hour after the procedure and treatment success rate at 6 months, defined as the proportion of participants achieving ≥50% reduction in NRS-11 pain score or a ≥4-point decrease from baseline (per IMMPACT).
Data was extracted from electronic records and procedure reports. Statistical comparisons will be made using appropriate parametric or non-parametric tests based on data distribution. This study seeks to contribute real-world evidence to guide clinicians in selecting safer, more effective injection strategies for managing chronic coccydynia
- Conditions
- Caudal Epidural Block, Coccygodynia, Coccydynia
- Keywords
- Chronic Coccydynia, Ganglion impar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ganglion Impar Block | This group includes adults with a diagnosis of chronic coccydynia who underwent a ganglion impar block as part of routine clinical care.The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach, with lateral and anteroposterior (AP) views obtained. With the loss-of-resistance technique, the needle was advanced along the intervertebral disc and the ventral tip was positioned anterior to the sacrococcygeal ligament. Needle placement was confirmed by injecting 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350, GE Healthcare, Ireland) into the retroperitoneal space. A total of 5 mL was then administered, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure. | |
| Group B: Ganglion Impar Block Combined with Caudal Epidural Steroid Injection | This group includes adults with chronic coccydynia who, as part of routine clinical care, received a combined caudal epidural steroid injection and ganglion impar block. The Caudal Epidural Steroid Injection procedure was performed under fluoroscopic guidance with both lateral and anteroposterior (AP) views. After subcutaneous infiltration of 1 mL of 2% lidocaine, a 22-gauge spinal needle was advanced into the caudal epidural space, and correct placement was confirmed by injection of 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350; GE Healthcare, Ireland). A total of 5 mL was then administered, consisting of 40 mg methylprednisolone acetate diluted in 4 mL of normal saline. Following the caudal epidural steroid injection, the ganglion impar block was performed as described for Group A. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS-11 pain score from baseline to 6 months
Within-participant change in pain intensity (ΔNRS = 6-month NRS-11 minus baseline NRS-11); negative values indicate improvement. NRS-11: 0=no pain, 10=worst pain.
Measured: Baseline and 6 months post-procedure
Secondary outcomes (2)
Treatment success rate at 6 months (IMMPACT)
Proportion of participants achieving ≥50% reduction in NRS-11 pain score or a ≥4-point decrease from baseline at 6 months (per IMMPACT). Non-responders are all others. NRS-11: 0=no pain, 10=worst pain.
Measured: Baseline and 6 months post-procedure
Change in NRS-11 pain score from baseline to 1 hour
Within-participant change in pain intensity (ΔNRS = 1-hour NRS-11 minus baseline NRS-11); negative values indicate improvement. NRS-11: 0=no pain, 10=worst pain.
Measured: Baseline and 1 hour post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2020
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caudal Epidural BlockStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Bakır, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200765
- Sponsor's protocol ID
- MERSINALG-COCCYDYNIA-2025
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared upon reasonable request. Data will be available after publication and can be requested by contacting the principal investigator.
Publications
Yavuz K, Bakir M, Ilcan B, Bercem E, Teker N, Rumeli S. Predictors of Long-Term Response to Ganglion Impar Block With or Without Caudal Epidural Steroid Injection in Chronic Coccydynia: A Retrospective Study. Pain Res Manag. 2026 Feb 26;2026:8614330. doi: 10.1155/prm/8614330. eCollection 2026.
PubMed 41768001
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Combination of Ganglion Impar Block and Caudal Epidural Steroid Injection Superior to Ganglion Impar Block Alone in Chronic Coccydynia? A Retrospective Study
- ClinicalTrials.gov ID
- NCT07200765
- Acronym / sponsor ID
- MERSINALG-COCCYDYNIA-2025
- Conditions
- Caudal Epidural Block, Coccygodynia, Coccydynia
- Keywords
- Chronic Coccydynia, Ganglion impar block
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 1 Oct 2025 (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.
Coccydynia refers to pain localized to the tailbone (coccygeal) region. Initial management is conservative-nonsteroidal anti-inflammatory drugs (NSAIDs), use of a seat cushion, and physical therapy-yet a proportion of patients remain symptomatic and subsequently pursue interventional options. The ganglion impar block (GIB), originally used to treat perineal cancer pain, is now recognized as an effective approach for perineal and coccygeal pain of both malignant and benign etiologies. Caudal epidural steroid injection (CESI) is also employed, either as monotherapy or in conjunction with other treatments; however, its precise role in coccydynia has not been clearly defined. Evidence directly comparing these injections is limited, and whether the combination confers superiority over GIB alone remains unresolved.
In this retrospective study, we will compare GIB alone versus GIB combined with CESI in adults treated for chronic coccydynia refractory to noninterventional management and evaluate any incremental benefit of the combination.
Detailed description
Coccydynia refers to pain localized to the coccygeal region that commonly intensifies with sitting and forward flexion. It frequently follows a fall or direct trauma and can constrain routine activities. The majority of patients respond to conservative management, including rest, use of a seat cushion, physical therapy, nonsteroidal anti-inflammatory agents, and lifestyle modification. For patients who remain symptomatic, a fluoroscopy-guided ganglion impar block can alleviate pain by modulating sympathetic pathways. The procedure is usually well tolerated; reported complications include infection, bleeding, and, rarely, rectal perforation.
Caudal epidural steroid injection (CESI), administered via the sacral canal, is an adjunctive option used to mitigate inflammation in the lumbosacral region. In selected patients, combining CESI with a ganglion impar block may enhance analgesic control by attenuating inflammation and sympathetic input.
In this retrospective cohort study, the comparative effectiveness of two injection strategies (GIB alone and GIB plus CESI) will be evaluated in adults with chronic coccydynia.
The medical records of patients who presented to the Algology Outpatient Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2020, and May 20, 2025, with chronic coccydynia and who underwent a ganglion impar block will be evaluated in a retrospective review. A minimum target sample size of 50 patients is planned. All included patients had previously received conservative treatment without clinical benefit. Patients were excluded if, at the time of injection, they had an active infection; a history of lumbar or coccygeal surgery; a documented hypersensitivity to local anesthetics or iodinated contrast agents; or a bleeding diathesis. Data collected: age, sex, trauma history, NRS-11 scores pre-procedure, 1 hour, 1 month and 6 month post-procedure.
The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach. The injectate volume was 5 mL, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride.
The caudal epidural steroid injection (CESI) was performed under fluoroscopic guidance with both lateral and anteroposterior views. A total of 5 mL was administered, comprising 40 mg methylprednisolone acetate diluted in 4 mL normal saline.
Outcome measures included:
Primary: Pain relief measured using a Numerical Rating Scale (NRS) at baseline and 6 months post-procedure.
Secondary: Change in NRS-11 pain score from baseline to 1 hour after the procedure and treatment success rate at 6 months, defined as the proportion of participants achieving ≥50% reduction in NRS-11 pain score or a ≥4-point decrease from baseline (per IMMPACT).
Data was extracted from electronic records and procedure reports. Statistical comparisons will be made using appropriate parametric or non-parametric tests based on data distribution. This study seeks to contribute real-world evidence to guide clinicians in selecting safer, more effective injection strategies for managing chronic coccydynia
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Ganglion Impar Block | – | –This group includes adults with a diagnosis of chronic coccydynia who underwent a ganglion impar block as part of routine clinical care.The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach, with lateral and anteroposterior (AP) views obtained. With the loss-of-resistance technique, the needle was advanced along the intervertebral disc and the ventral tip was positioned anterior to the sacrococcygeal ligament. Needle placement was confirmed by injecting 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350, GE Healthcare, Ireland) into the retroperitoneal space. A total of 5 mL was then administered, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure. |
| Group B: Ganglion Impar Block Combined with Caudal Epidural Steroid Injection | – | –This group includes adults with chronic coccydynia who, as part of routine clinical care, received a combined caudal epidural steroid injection and ganglion impar block. The Caudal Epidural Steroid Injection procedure was performed under fluoroscopic guidance with both lateral and anteroposterior (AP) views. After subcutaneous infiltration of 1 mL of 2% lidocaine, a 22-gauge spinal needle was advanced into the caudal epidural space, and correct placement was confirmed by injection of 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350; GE Healthcare, Ireland). A total of 5 mL was then administered, consisting of 40 mg methylprednisolone acetate diluted in 4 mL of normal saline. Following the caudal epidural steroid injection, the ganglion impar block was performed as described for Group A. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults with chronic coccydynia who received either a ganglion impar block (GIB) alone or a combined with caudal epidural steroid injection as part of routine clinical care at the Algology Clinic of Mersin University Hospital between January 1, 2020, and May 20, 2025. Patients were not assigned to treatments by protocol; intervention choice reflected clinician judgment and patient characteristics. Outcomes (e.g., NRS-11 pain scores) were abstracted from medical records at baseline and follow-up.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Chronic coccydynia >3 months
- Inadequate response to conservative treatments
- Written informed consent documented for the procedure (per records)
Key exclusion criteria (6 listed)
- Active infection on the injection date.
- History of lumbar or coccygeal surgery
- Allergy to local anesthetics or contrast media
- Coagulopathy / anticoagulant therapy contraindicating the procedure
- Inadequate follow-up documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in NRS-11 pain score from baseline to 6 months
Time frame: Baseline and 6 months post-procedure
Within-participant change in pain intensity (ΔNRS = 6-month NRS-11 minus baseline NRS-11); negative values indicate improvement. NRS-11: 0=no pain, 10=worst pain.
2 secondary outcomes
Treatment success rate at 6 months (IMMPACT)
Time frame: Baseline and 6 months post-procedure
Change in NRS-11 pain score from baseline to 1 hour
Time frame: Baseline and 1 hour 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 1 Oct 2025.
- Derived from this study: PubMed 41768001Yavuz K, Bakir M, Ilcan B, Bercem E, Teker N, Rumeli S. Predictors of Long-Term Response to Ganglion Impar Block With or Without Caudal Epidural Steroid Injection in Chronic Coccydynia: A Retrospective Study. Pain Res Manag. 2026 Feb 26;2026:8614330. doi: 10.1155/prm/8614330. eCollection 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared upon reasonable request. Data will be available after publication and can be requested by contacting the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caudal Epidural Block and Coccygodynia, run by Mersin 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. 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?
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?
Change in NRS-11 pain score from baseline to 6 months (time frame: Baseline and 6 months post-procedure). 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 NCT07200765, which also lists 1 linked publication.
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 1 Oct 2025.