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临床试验/NCT07200765
NCT07200765进行中(未招募)不适用

Is the Combination of Ganglion Impar Block and Caudal Epidural Steroid Injection Superior to Ganglion Impar Block Alone in Chronic Coccydynia? A Retrospective Study

Mersin University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
56
试验地点
1
主要终点
Change in NRS-11 pain score from baseline to 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in NRS-11 pain score from baseline to 6 months

时间窗: 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.

次要结局

  • Treatment success rate at 6 months (IMMPACT)(Baseline and 6 months post-procedure)
  • Change in NRS-11 pain score from baseline to 1 hour(Baseline and 1 hour post-procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesut Bakır

Associate Professor

Mersin University

研究点 (1)

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