Efficacy of Interventional Methods Used in the Treatment of Coccydynia

NCT06653179 | Not Yet Recruiting

• 1 other identifier: Sacral ESP vs Caudal Epidural
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of sacral erector spinae plane block and caudal epidural injection in patients with coccydynia resistant to conservative treatments. Ultrasound guidance will be used for sacral erector spinae plane block, while fluoroscopic guidance will be applied for caudal epidural injection. The effectiveness of these treatments will be assessed through face-to-face questionnaires, the Numerical Rating Scale and the Paris Functional Coccydynia Scale at first, fourth and twelfth-week follow-ups.

Conditions

Coccydynia; Erector Spinae Plane Block; Caudal Block

Keywords

Sacral Erector Spinae Plane Block; Caudal. Epidural Injection; Chronic Coccydynia

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale

  Numeric Rating Scale is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

  Change from baseline to 1st and 2nd and twelfth week after treatment

• Paris Functional Coccydynia Scale

  The Paris Functional Coccydynia Scale is designed to assess the functional impact of coccydynia on patients' daily lives. It comprises various items that evaluate pain intensity, functional limitations, and the effect of pain on daily activities. Scores range from 0 to 10, with higher scores indicating greater impairment and more severe symptoms.

  Change from baseline to 1st and 2nd and twelfth week after treatment

Study Arms (2)

Sacral Erector Spinae Plane Block Group

ACTIVE COMPARATOR

Sacral Erector Spinae Plane Block for Chronic Coccydynia

Procedure: Sacral Erector Spinae Plane Block

Caudal Epidural Injection Gropu

ACTIVE COMPARATOR

Caudal Epidural Injection for Chronic Coccydynia

Procedure: Caudal Epidural Injection

Interventions

Sacral Erector Spinae Plane Block PROCEDURE

The patient is placed in the prone positionon a procedure table. The sacral region is exposed, and the area is prepped with antiseptic solution under sterile conditions. The ultrasound high-frequency linear transducer is placed transversely over the sacrum. The sacral cornua are typically seen as bony structures adjacent to the sacral hiatus, appearing as two hyperechoic structures. Rotate the ultrasound probe to a sagittal position over the sacrum to align with the fourth and fifth sacral vertebrae. Under continuous ultrasound guidance, block needle is inserted in-plane with the ultrasound probe. Direct the needle through the soft tissue towards the plane between the erector spinae muscle and the sacrum. After confirming needle placement, the injectate mixture of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is administered. A total volume of 10 mL is injected, and real-time ultrasound is used to observe the spread of the injectate within the target tissue plane.

Sacral Erector Spinae Plane Block Group

Caudal Epidural Injection PROCEDURE

The patient is positioned in the prone position on the procedure table, and the sacral region is exposed and prepped with antiseptic solution under sterile conditions. The fluoroscope is positioned laterally to visualize the sacral hiatus. Under fluoroscopic guidance, the block needle is inserted through the skin and advanced toward the sacral hiatus. Continuous fluoroscopy is used to ensure correct needle placement, typically visualized at the level of the sacral canal. After confirming the appropriate position with contrast media, the injectate consisting of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is slowly administered, with a total volume of 10 mL. During injection, careful monitoring of the needle position is performed to avoid intravascular injection. After the procedure, patients are monitored for potential complications such as hypotension and allergic reactions.

Caudal Epidural Injection Gropu

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic coccydynia unresponsive to conservative treatment
• Male and female population aged 18-70
• No previous interventional procedure performed during the treatment process

You may not qualify if:

• Coagulation disorders
• Infections in the areas to be treated
• Allergy to local anesthesia
• Socio-cultural inadequacy
• Mental retardation
• Pregnancy
• Previous interventional procedure performed
• Patient refusal of the interventional procedure
• Presence of malignancy in the coccygeal region
• Previous surgery in the coccygeal region

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

Location

Central Study Contacts

Ufuk Turan

CONTACT

+905395594772; drufukturan@gmail.com

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: October 20, 2024
• First Posted: October 22, 2024
• Study Start: November 15, 2024
• Primary Completion: August 15, 2025
• Study Completion: November 15, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

TU (1)