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

NCT ID: NCT07200765

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-11-01

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

Conditions

Caudal Epidural Block; Coccygodynia; Coccydynia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A: Ganglion Impar Block

This group includes adults with a diagnosis of chronic coccydynia who underwent a ganglion impar block as part of routine clinical care.The ganglion impar block was performed under fluoroscopic guidance using a transsacrococcygeal approach, with lateral and anteroposterior (AP) views obtained. With the loss-of-resistance technique, the needle was advanced along the intervertebral disc and the ventral tip was positioned anterior to the sacrococcygeal ligament. Needle placement was confirmed by injecting 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350, GE Healthcare, Ireland) into the retroperitoneal space. A total of 5 mL was then administered, consisting of 1 mL methylprednisolone acetate (40 mg/mL), 2 mL normal saline, and 2 mL 0.5% bupivacaine hydrochloride. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure.

No interventions assigned to this group

Group B: Ganglion Impar Block Combined with Caudal Epidural Steroid Injection

This group includes adults with chronic coccydynia who, as part of routine clinical care, received a combined caudal epidural steroid injection and ganglion impar block. The Caudal Epidural Steroid Injection procedure was performed under fluoroscopic guidance with both lateral and anteroposterior (AP) views. After subcutaneous infiltration of 1 mL of 2% lidocaine, a 22-gauge spinal needle was advanced into the caudal epidural space, and correct placement was confirmed by injection of 1 mL of iohexol 350 mg/mL contrast (Omnipaque 350; GE Healthcare, Ireland). A total of 5 mL was then administered, consisting of 40 mg methylprednisolone acetate diluted in 4 mL of normal saline. Following the caudal epidural steroid injection, the ganglion impar block was performed as described for Group A. Outcomes were abstracted from records at baseline, 1 hour, 1 month and 6 month after the procedure.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Mesut Bakır

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mersin University Faculty of Medicine, Department of Algology

Mersin, Mersin, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MERSINALG-COCCYDYNIA-2025

Identifier Type: -

Identifier Source: org_study_id