Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia

NCT06858917 | Recruiting

• 1 other identifier: 22.05.2024.01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccygodynia; Coccydynia

Keywords

Coccygodynia; Coccydynia; impar block; sacral erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• 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.

  Preprocedural, Week 1, Week 4, Week 12

Secondary Outcomes (3)

• Short Form-12

  Preprocedural, Week 1, Week 4, Week 12

• Pain-free sitting duration

  Preprocedural, Week 1, Week 4, Week 12

• Oswetry Disability Index

  Preprocedural, Week 1, Week 4, Week 12

Study Arms (2)

Ganglion İmpar Block Group

ACTIVE COMPARATOR

Participants in this group will performed ganglion impar block

Procedure: Ganglion Impar Block

Sacral Erector Spinae Plane Block

ACTIVE COMPARATOR

Participants in this group will performed sacral erector spinae plane block

Procedure: Sacral Erector Spinae Plane Block

Interventions

Ganglion Impar Block PROCEDURE

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.

Also known as: impar block

Ganglion İmpar Block Group

Sacral Erector Spinae Plane Block PROCEDURE

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.

Also known as: Sacral multifidus plane block

Sacral Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

RECRUITING

Study Officials

• Tuba Tanyel Saraçoğlu

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Tanyel Saraçoğlu, Medical Doctor

CONTACT

+0905396210136; tuba.saracoglu1@saglik.gov.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)