Clinical trial NCT06858917: Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia
Official title: Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block for Chronic Coccygodynia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coccygodynia
Coccydynia
Keywords: Coccygodynia
Coccydynia
impar block
sacral erector spinae plane block
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Preprocedural, Week 1, Week 4, Week 12
Secondary outcomes:
measure: Short Form-12
timeFrame: Preprocedural, Week 1, Week 4, Week 12
measure: Pain-free sitting duration
timeFrame: Preprocedural, Week 1, Week 4, Week 12
measure: Oswetry Disability Index
timeFrame: Preprocedural, Week 1, Week 4, Week 12
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Başakşehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Tuba Tanyel Saraçoğlu
role: PRINCIPAL_INVESTIGATOR
References: