CoccygodyniaNCT06858917
Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia
A study testing Ganglion Impar Block and Sacral Erector Spinae Plane Block in people with Coccygodynia and Coccydynia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Coccygodynia is a condition that causes pain in the tailbone (coccyx) area. While it can develop after trauma, such as a fall or fracture, in some cases, no clear cause is identified. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccygodynia, Coccydynia
- What is being tested?
- Ganglion Impar Block and Sacral Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Oct 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who have had chronic coccygodynia for at least 3 months
- Being between the ages of 18-65
- Patients who do not respond to conservative treatments (analgesics, physical therapy modalities etc.) and are scheduled for interventional pain procedures
Who cannot join
- Patients who have undergone surgery to the coccyx region
- Having undergone an interventional pain procedure in the lumbar, sacral and coccyx regions within the last year
- Patients with systemic infection, local infection at the application site, and coagulopathy
- Pregnant and breastfeeding patients
- Having endocrine or rheumatological disease that may affect the musculoskeletal system in the relevant region and lead to diagnostic complexity (such as spondyloarthropathy)
- Patients with musculoskeletal system pathology that may contribute to symptoms in the relevant region and affect the evaluation of treatment results (such as lumbar disc herniation, sacroiliitis, spinal stenosis)
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- Those with lumbar, sacral or coccygeal vertebra fractures
- Those with a history of allergic reactions to the contents of the injectate to be administered during an interventional pain procedure (especially contrast agent and local anesthetic)
- Those with mental disorders that may affect the evaluation during the follow-up periods during the study
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
Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir
Tuba Tanyel Saraçoğlu, Medical Doctor, +0905396210136, tuba.saracoglu1@saglik.gov.tr
About this study
Official title: Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block for Chronic Coccygodynia: a Randomized Controlled Trial
Coccygodynia is a condition that causes pain in the tailbone (coccyx) area. While it can develop after trauma, such as a fall or fracture, in some cases, no clear cause is identified. Patients who do not experience relief from standard treatments like pain medications, physical therapy, and posture adjustments may be referred to specialized pain management clinics for further treatment options.
Several interventional procedures can help manage coccygodynia. These include impar ganglion block, radiofrequency ablation, caudal epidural steroid injections, sacral erector spinae plane (ESP) block, and coccygeal nerve blocks. These procedures are commonly performed in pain treatment centers and aim to reduce discomfort by targeting specific nerves responsible for transmitting pain signals.
Read more
Impar ganglion block is one of the most frequently used treatments for coccygodynia. It involves injecting a local anesthetic, with or without steroids, into a small nerve cluster in front of the sacrococcygeal joint. This procedure is performed under ultrasound and/or fluoroscopic (X-ray) guidance in a sterile operating room setting to ensure accuracy and safety. While the goal is to relieve pain, potential risks include temporary worsening of pain, bleeding, infection, or, in rare cases, rectal injury.
Another interventional option is the sacral erector spinae plane (ESP) block, a technique that delivers local anesthetic under the erector spinae muscles in the sacrum. This procedure, also performed under ultrasound guidance in a sterile environment, is used to block pain signals from the coccyx and surrounding areas. Like the impar ganglion block, it can be effective for pain relief, but possible side effects include temporary pain increase, bleeding, and infection at the injection site.
Both procedures are minimally invasive.
Read the detailed description
Coccygodynia is defined as pain localized in the coccygeal region. While previous trauma and fractures may contribute to its development, in many cases, no identifiable etiology can be determined. Patients who continue to experience pain despite conservative treatment and physiotherapy are often referred to pain management outpatient clinics for interventional treatment options. Various interventional procedures are utilized in the management of coccygodynia, including impar ganglion block and radiofrequency applications, caudal epidural steroid injections, sacral erector spinae plane block, and coccygeal nerve blocks, all of which are commonly performed in pain treatment clinics. Impar ganglion block is administered under sterile conditions in the sacrococcygeal region within an operating room setting, utilizing ultrasound and/or fluoroscopic guidance. This procedure aims to alleviate pain; however, potential complications include increased pain, bleeding at the procedural site, rectal perforation, and infection. Sacral erector spinae plane block is another interventional approach performed under sterile conditions in the operating room using ultrasound guidance. Similar to the impar ganglion block, its primary objective is pain reduction, though it also carries risks such as increased pain, bleeding, and infection at the procedural site
- Conditions
- Coccygodynia, Coccydynia
- Being tested
- Ganglion Impar Block, Sacral Erector Spinae Plane Block
- Keywords
- Coccygodynia, Coccydynia, impar block, sacral erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglion Impar BlockProcedure or surgery
Also called impar block
Block of the ganglion impar is performed by injecting a mixture of steroid and local anaesthetic in front of the sacrococcygeal joint. This procedure is performed in a sterile operating theatre under ultrasound and/or fluoroscopic (X-ray) guidance. Radiopaque agents are also used during the procedure to confirm the location.
Sacral Erector Spinae Plane BlockProcedure or surgery
Also called Sacral multifidus plane block
The sacral erector spina plan block is performed with ultrasound guidance by injecting a high volume mixture of local anaesthetic and steroid into the fascia under the erector spina muscles in the sacral region.
| Study group | Role | What they receive |
|---|---|---|
| Ganglion İmpar Block Group | Active comparator | Participants in this group will performed ganglion impar block Receives: Procedure: Ganglion Impar Block |
| Sacral Erector Spinae Plane Block | Active comparator | Participants in this group will performed sacral erector spinae plane block Receives: Procedure: Sacral Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
The Numeric Rating Scale (NRS) is an 11-point scale (0-10) used to assess pain intensity, with 0 indicating 'no pain' and 10 representing 'worst possible pain.
Measured: Preprocedural, Week 1, Week 4, Week 12
Secondary outcomes (3)
Short Form-12
The Short Form-12 (SF-12) is a validated questionnaire assessing health-related quality of life. It generates separate Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, where higher scores indicate better physical and mental health, while lower scores reflect poorer health status.
Measured: Preprocedural, Week 1, Week 4, Week 12
Pain-free sitting duration
Patients will be asked to assess and record their pain-free sitting durations on the hard and soft surfaces they regularly use during pre-procedural and post-procedural follow-ups. They will be specifically instructed to perform these assessments using the same hard and soft surfaces each time.
Measured: Preprocedural, Week 1, Week 4, Week 12
Oswetry Disability Index
The Oswestry Disability Index (ODI) was used to assess the degree of disability. The ODI consists of 10 items, evaluating pain intensity, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling, and pain-related distress.
Measured: Preprocedural, Week 1, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Mar 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccygodyniaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuba Tanyel Saraçoğlu, Başakşehir Çam & Sakura City Hospital
- Investigators
- Tuba Tanyel Saraçoğlu, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858917
- Sponsor's protocol ID
- 22.05.2024.01
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block for Chronic Coccygodynia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06858917
- Acronym / sponsor ID
- 22.05.2024.01
- Conditions
- Coccygodynia, Coccydynia
- Keywords
- Coccygodynia, Coccydynia, impar block, sacral erector spinae plane block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 5 Mar 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.
Coccygodynia is a condition that causes pain in the tailbone (coccyx) area. While it can develop after trauma, such as a fall or fracture, in some cases, no clear cause is identified. Patients who do not experience relief from standard treatments like pain medications, physical therapy, and posture adjustments may be referred to specialized pain management clinics for further treatment options.
Several interventional procedures can help manage coccygodynia. These include impar ganglion block, radiofrequency ablation, caudal epidural steroid injections, sacral erector spinae plane (ESP) block, and coccygeal nerve blocks. These procedures are commonly performed in pain treatment centers and aim to reduce discomfort by targeting specific nerves responsible for transmitting pain signals.
Impar ganglion block is one of the most frequently used treatments for coccygodynia. It involves injecting a local anesthetic, with or without steroids, into a small nerve cluster in front of the sacrococcygeal joint. This procedure is performed under ultrasound and/or fluoroscopic (X-ray) guidance in a sterile operating room setting to ensure accuracy and safety. While the goal is to relieve pain, potential risks include temporary worsening of pain, bleeding, infection, or, in rare cases, rectal injury.
Another interventional option is the sacral erector spinae plane (ESP) block, a technique that delivers local anesthetic under the erector spinae muscles in the sacrum. This procedure, also performed under ultrasound guidance in a sterile environment, is used to block pain signals from the coccyx and surrounding areas. Like the impar ganglion block, it can be effective for pain relief, but possible side effects include temporary pain increase, bleeding, and infection at the injection site.
Both procedures are minimally invasive.
Detailed description
Coccygodynia is defined as pain localized in the coccygeal region. While previous trauma and fractures may contribute to its development, in many cases, no identifiable etiology can be determined. Patients who continue to experience pain despite conservative treatment and physiotherapy are often referred to pain management outpatient clinics for interventional treatment options. Various interventional procedures are utilized in the management of coccygodynia, including impar ganglion block and radiofrequency applications, caudal epidural steroid injections, sacral erector spinae plane block, and coccygeal nerve blocks, all of which are commonly performed in pain treatment clinics. Impar ganglion block is administered under sterile conditions in the sacrococcygeal region within an operating room setting, utilizing ultrasound and/or fluoroscopic guidance. This procedure aims to alleviate pain; however, potential complications include increased pain, bleeding at the procedural site, rectal perforation, and infection. Sacral erector spinae plane block is another interventional approach performed under sterile conditions in the operating room using ultrasound guidance. Similar to the impar ganglion block, its primary objective is pain reduction, though it also carries risks such as increased pain, bleeding, and infection at the procedural site
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganglion İmpar Block Group | Active comparator | Procedure: Ganglion Impar BlockParticipants in this group will performed ganglion impar block |
| Sacral Erector Spinae Plane Block | Active comparator | Procedure: Sacral Erector Spinae Plane BlockParticipants in this group will performed sacral erector spinae plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who have had chronic coccygodynia for at least 3 months
- Being between the ages of 18-65
- Patients who do not respond to conservative treatments (analgesics, physical therapy modalities etc.) and are scheduled for interventional pain procedures
Key exclusion criteria (9 listed)
- Patients who have undergone surgery to the coccyx region
- Having undergone an interventional pain procedure in the lumbar, sacral and coccyx regions within the last year
- Patients with systemic infection, local infection at the application site, and coagulopathy
- Pregnant and breastfeeding patients
- Having endocrine or rheumatological disease that may affect the musculoskeletal system in the relevant region and lead to diagnostic complexity (such as spondyloarthropathy)
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 BlockAlso: impar blockBlock of the ganglion impar is performed by injecting a mixture of steroid and local anaesthetic in front of the sacrococcygeal joint. This procedure is performed in a sterile operating theatre under ultrasound and/or fluoroscopic (X-ray) guidance. Radiopaque agents are also used during the procedure to confirm the location. | Procedure or surgery | Ganglion İmpar Block Group |
| Sacral Erector Spinae Plane BlockAlso: Sacral multifidus plane blockThe sacral erector spina plan block is performed with ultrasound guidance by injecting a high volume mixture of local anaesthetic and steroid into the fascia under the erector spina muscles in the sacral region. | Procedure or surgery | Sacral Erector Spinae Plane Block |
Primary outcome
Numeric Rating Scale
Time frame: Preprocedural, Week 1, Week 4, Week 12
The Numeric Rating Scale (NRS) is an 11-point scale (0-10) used to assess pain intensity, with 0 indicating 'no pain' and 10 representing 'worst possible pain.
3 secondary outcomes
Short Form-12
Time frame: Preprocedural, Week 1, Week 4, Week 12
Pain-free sitting duration
Time frame: Preprocedural, Week 1, Week 4, Week 12
Oswetry Disability Index
Time frame: Preprocedural, Week 1, Week 4, Week 12
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 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Coccygodynia
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Conventional vs Pulsed RF in Coccydynia
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Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
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Not yet recruitingObservational study
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
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Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia
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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.
Tuba Tanyel Saraçoğlu principal investigator
Başakşehir Çam & Sakura City Hospital
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 Block and Sacral Erector Spinae Plane Block in people with Coccygodynia and Coccydynia, run by Başakşehir Çam & Sakura City Hospital 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 9 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 24 Mar 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?
Contact Tuba Tanyel Saraçoğlu, Medical Doctor (+0905396210136, tuba.saracoglu1@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Preprocedural, Week 1, Week 4, Week 12). 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 24 Mar 2025.