Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuba Tanyel Saraçoğlu, Medical Doctor
- Phone Number: +0905396210136
- Email: tuba.saracoglu1@saglik.gov.tr
Study Locations
-
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Başakşehir
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İstanbul, Başakşehir, Turkey
- Recruiting
- Başakşehir Çam and Sakura City Hospital
-
Contact:
- Tuba Tanyel Saraçoğlu, Medical Doctor
- Phone Number: +0905396210136
- Email: tuba.saracoglu1@saglik.gov.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ganglion İmpar Block Group
Participants in this group will performed ganglion 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.
Other Names:
|
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Active Comparator: Sacral Erector Spinae Plane Block
Participants in this group will performed sacral erector spinae 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preprocedural, Week 1, Week 4, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form-12
Time Frame: Preprocedural, Week 1, Week 4, Week 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.
|
Preprocedural, Week 1, Week 4, Week 12
|
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Pain-free sitting duration
Time Frame: Preprocedural, Week 1, Week 4, Week 12
|
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.
|
Preprocedural, Week 1, Week 4, Week 12
|
|
Oswetry Disability Index
Time Frame: Preprocedural, Week 1, Week 4, Week 12
|
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.
|
Preprocedural, Week 1, Week 4, Week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tuba Tanyel Saraçoğlu, Başakşehir Çam & Sakura City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22.05.2024.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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