Efficacy of Combining Caudal Epidural Steroid With Ganglion Impar Block in Chronic Coccydynia

Active, not recruiting

• Conditions: Caudal Epidural Block; Coccygodynia; Coccydynia

• Registration Number: NCT07200765
• Lead Sponsor: Mersin University

Brief Summary

Coccydynia refers to pain localized to the tailbone (coccygeal) region. Initial management is conservative-nonsteroidal anti-inflammatory drugs (NSAIDs), use of a seat cushion, and physical therapy-yet a proportion of patients remain symptomatic and subsequently pursue interventional options. The ganglion impar block (GIB), originally used to treat perineal cancer pain, is now recognized as an effective approach for perineal and coccygeal pain of both malignant and benign etiologies. Caudal epidural steroid injection (CESI) is also employed, either as monotherapy or in conjunction with other treatments; however, its precise role in coccydynia has not been clearly defined. Evidence directly comparing these injections is limited, and whether the combination confers superiority over GIB alone remains unresolved.

In this retrospective study, we will compare GIB alone versus GIB combined with CESI in adults treated for chronic coccydynia refractory to noninterventional management and evaluate any incremental benefit of the combination.

Detailed Description

Coccydynia refers to pain localized to the coccygeal region that commonly intensifies with sitting and forward flexion. It frequently follows a fall or direct trauma and can constrain routine activities. The majority of patients respond to conservative management, including rest, use of a seat cushion, physical therapy, nonsteroidal anti-inflammatory agents, and lifestyle modification. For patients who remain symptomatic, a fluoroscopy-guided ganglion impar block can alleviate pain by modulating sympathetic pathways. The procedure is usually well tolerated; reported complications include infection, bleeding, and, rarely, rectal perforation.

Caudal epidural steroid injection (CESI), administered via the sacral canal, is an adjunctive option used to mitigate inflammation in the lumbosacral region. In selected patients, combining CESI with a ganglion impar block may enhance analgesic control by attenuating inflammation and sympathetic input.

In this retrospective cohort study, the comparative effectiveness of two injection strategies (GIB alone and GIB plus CESI) will be evaluated in adults with chronic coccydynia.

The medical records of patients who presented to the Algology Outpatient Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2020, and May 20, 2025, with chronic coccydynia and who underwent a ganglion impar block will be evaluated in a retrospective review. A minimum target sample size of 50 patients is planned. All included patients had previously received conservative treatment without clinical benefit. Patients were excluded if, at the time of injection, they had an active infection; a history of lumbar or coccygeal surgery; a documented hypersensitivity to local anesthetics or iodinated contrast agents; or a bleeding diathesis. Data collected: age, sex, trauma history, NRS-11 scores pre-procedure, 1 hour, 1 month and 6 month post-procedure.

The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach. The injectate volume was 5 mL, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride.

The caudal epidural steroid injection (CESI) was performed under fluoroscopic guidance with both lateral and anteroposterior views. A total of 5 mL was administered, comprising 40 mg methylprednisolone acetate diluted in 4 mL normal saline.

Outcome measures included:

Primary: Pain relief measured using a Numerical Rating Scale (NRS) at baseline and 6 months post-procedure.

Secondary: Change in NRS-11 pain score from baseline to 1 hour after the procedure and treatment success rate at 6 months, defined as the proportion of participants achieving ≥50% reduction in NRS-11 pain score or a ≥4-point decrease from baseline (per IMMPACT).

Data was extracted from electronic records and procedure reports. Statistical comparisons will be made using appropriate parametric or non-parametric tests based on data distribution. This study seeks to contribute real-world evidence to guide clinicians in selecting safer, more effective injection strategies for managing chronic coccydynia

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Primary Completion: 2025-10-01
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Age ≥18 years
• Chronic coccydynia >3 months
• Inadequate response to conservative treatments
• Written informed consent documented for the procedure (per records)

Exclusion Criteria

• Active infection on the injection date.
• History of lumbar or coccygeal surgery
• Allergy to local anesthetics or contrast media
• Coagulopathy / anticoagulant therapy contraindicating the procedure
• Inadequate follow-up documentation
• Injection performed to a different region during the indexed procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in NRS-11 pain score from baseline to 6 months	Baseline and 6 months post-procedure	Within-participant change in pain intensity (ΔNRS = 6-month NRS-11 minus baseline NRS-11); negative values indicate improvement. NRS-11: 0=no pain, 10=worst pain.

Secondary Outcome Measures

Name	Time	Method
Treatment success rate at 6 months (IMMPACT)	Baseline and 6 months post-procedure	Proportion of participants achieving ≥50% reduction in NRS-11 pain score or a ≥4-point decrease from baseline at 6 months (per IMMPACT). Non-responders are all others. NRS-11: 0=no pain, 10=worst pain.
Change in NRS-11 pain score from baseline to 1 hour	Baseline and 1 hour post-procedure.	Within-participant change in pain intensity (ΔNRS = 1-hour NRS-11 minus baseline NRS-11); negative values indicate improvement. NRS-11: 0=no pain, 10=worst pain.

Trial Locations

Locations (1)

Mersin University Faculty of Medicine, Department of Algology; Mersin, Mersin, Turkey (Türkiye)