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临床试验/NCT06653179
NCT06653179尚未招募不适用

Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Injection on Chronic Coccydynia: A Randomized Controlled Trial

Ankara Etlik City Hospital2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
94
试验地点
2
主要终点
Numeric Rating Scale

研究概览

简要总结

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.

详细描述

Coccydynia (coccygodynia, coccalgia) or coccygeal pain is a painful syndrome affecting the coccyx region. The most important etiological factors in the formation of coccydynia are external and internal trauma, though it can also occur idiopathically. The pain intensifies while sitting or standing up from a sitting position. Although it can affect individuals of all ages and genders, the average onset age is 40, with a prevalence 5 times higher in women. Coccydynia is a painful condition that impacts quality of life, and its treatment can be challenging due to the influence of various physiological and psychological factors.

Patients typically complain of pain in the tailbone area, which increases with prolonged sitting, leaning backward while sitting, standing for extended periods, and rising from a sitting position. Conservative treatments such as nonsteroidal anti-inflammatory drugs, levator ani relaxation exercises, seating cushions, and transcutaneous electrical stimulation are commonly used, but these methods are ineffective in 10% of cases.

For patients unresponsive to conservative treatments, interventional and surgical options include caudal epidural steroid injection, sacral erector spinae plane block, ganglion impar blocks, radiofrequency ablation of sacral nerves, block and radiofrequency ablation of coccygeal nerves, and coccygectomy.

Sacral erector spinae plane block under ultrasound guidance or caudal epidural injection under fluoroscopic guidance is performed under sterile conditions for patients with resistant and chronic coccydynia. For the sacral erector spinae plane block, the sacral and coccygeal cornua are visualized in a transverse position under ultrasound, followed by sagittal positioning of the probe over the sacrum for injection at the 4th and 5th sacral vertebrae. For caudal epidural injection, the fluoroscope is positioned laterally, and the injection is administered to the target area under fluoroscopic imaging. In both techniques, the injectate consists of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration), with a total volume of 10 mL. After the procedure, patients are monitored for potential hypotension and allergic reactions as a precaution.

This study will include patients treated with sacral erector spinae plane block and caudal epidural injection for coccydynia resistant to conservative treatments. Face-to-face questionnaires, Numerical Rating Scale scores, and the Paris Functional Coccydynia Scale will be evaluated at 1, 4, and 12-week follow-ups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Numeric Rating Scale

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

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

Paris Functional Coccydynia Scale

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

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.

次要结局

未报告次要终点

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ufuk Turan, MD

Principal Investigator

Ankara Etlik City Hospital

研究点 (2)

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