NCT06858917 Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia
| NCT ID | NCT06858917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Başakşehir Çam & Sakura City Hospital |
| Condition | Coccygodynia |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2025-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-03-15 with a primary completion date of 2025-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Contact & Investigator
Tuba Tanyel Saraçoğlu
PRINCIPAL INVESTIGATOR
Başakşehir Çam & Sakura City Hospital
Frequently Asked Questions
Who can join the NCT06858917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Coccygodynia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06858917 currently recruiting?
Yes, NCT06858917 is actively recruiting participants. Contact the research team at tuba.saracoglu1@saglik.gov.tr for enrollment information.
Where is the NCT06858917 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06858917 clinical trial?
NCT06858917 is sponsored by Başakşehir Çam & Sakura City Hospital. The principal investigator is Tuba Tanyel Saraçoğlu at Başakşehir Çam & Sakura City Hospital. The trial plans to enroll 130 participants.