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临床试验/NCT07487935
NCT07487935进行中(未招募)不适用

Determinants of Clinical Success After Caudal Epidural Adhesiolysis in Chronic Lumbar Radicular Pain: A Retrospective Cohort Study

Mersin University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023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
40
试验地点
1
主要终点
Clinical success based on change in pain intensity measured by the Numeric Rating Scale (NRS)

研究概览

简要总结

Chronic lumbar radicular pain is a frequently encountered condition that can cause marked pain, limited physical function, and a substantial decline in quality of life. For patients whose symptoms do not respond adequately to conservative treatment, caudal epidural adhesiolysis is considered a minimally invasive treatment option, particularly when epidural fibrosis or adhesions are thought to contribute to persistent pain.

Even so, treatment response after caudal epidural adhesiolysis is not the same for every patient. Some individuals experience meaningful clinical improvement, whereas others obtain limited benefit. Understanding which factors are associated with a favorable outcome may help clinicians make better treatment decisions and identify patients who are more likely to benefit from the procedure.

In this single-center retrospective cohort study, we reviewed the medical records of patients with chronic lumbar radicular pain who underwent caudal epidural adhesiolysis. The purpose of the study is to evaluate clinical success after the procedure and to explore demographic, clinical, and procedure-related factors that may influence treatment outcomes.

详细描述

This single-center retrospective cohort study will evaluate the medical records of 40 eligible patients who underwent caudal epidural adhesiolysis at the Mersin University Algology Clinic between March 1, 2023, and January 1, 2026, for chronic lumbar radicular pain or pain related to epidural adhesions. Eligibility will be determined according to the predefined inclusion and exclusion criteria. In patients who underwent more than one procedure during the study period, only the first (index) caudal epidural adhesiolysis will be included in the analysis.

The primary focus of the study is to assess clinical success following caudal epidural adhesiolysis and to examine changes in pain and clinical improvement measures during follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), and functional status will be evaluated using the Oswestry Disability Index (ODI) before the procedure and at follow-up visits. Analyses of clinical success and treatment-related change will be based on these outcome measures.

Potential factors associated with treatment outcome will also be examined. These variables will include demographic and clinical characteristics, such as age, sex, symptom duration, diagnosis, history of previous lumbar surgery, baseline pain severity, and prior or concurrent treatments, as well as selected procedure-related variables, including the level to which the catheter was advanced, medications administered during the procedure, and procedure-related complications.

All study data will be collected from the electronic medical record system and patient files. The study is designed to identify factors that may be associated with favorable clinical outcomes after caudal epidural adhesiolysis in patients with chronic lumbar radicular pain and to contribute to improved patient selection in interventional pain practice.

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 or older
  • Underwent caudal epidural adhesiolysis at the Mersin University Faculty of Medicine, Algology Clinic between March 1, 2023, and January 1, 2026
  • Evaluated with a diagnosis of chronic lumbar radicular pain or pain related to epidural adhesions
  • Availability of pre-procedural clinical data in the medical records
  • Availability of procedural technical records in the medical file, including at minimum the procedure date, the level to which the catheter was advanced, and the medications administered and/or procedural details
  • Availability of post-procedural follow-up data including Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) scores

排除标准

  • Patients younger than 18 years
  • Patients who underwent caudal epidural adhesiolysis outside the period from March 1, 2023, to January 1, 2026, at the Mersin University Faculty of Medicine, Algology Clinic
  • Patients without a diagnosis of chronic lumbar radicular pain or pain related to epidural adhesions
  • Missing essential pre-procedural clinical data in the medical records
  • Insufficient procedural technical documentation in the medical file
  • Absence of post-procedural clinical follow-up data
  • Missing Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) scores in the follow-up records

结局指标

主要结局

Clinical success based on change in pain intensity measured by the Numeric Rating Scale (NRS)

时间窗: Baseline, 1 month, and 3 months after the procedure

Pain intensity will be assessed using the Numeric Rating Scale (0-10) before caudal epidural adhesiolysis and during follow-up.

次要结局

未报告次要终点

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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