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Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain

2026年11月5日 更新者：ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study

This prospective, longitudinal observational study evaluates functional recovery, pain intensity, and lumbar mobility after a fluoroscopy-guided lumbar facet joint block in patients with chronic lumbar facet syndrome. Forty patients receiving standard-of-care injections (ropivacaine 0.2% and methylprednisolone) will be observed. Outcomes are measured at baseline and 30 days post-intervention. The primary outcome is the change in Oswestry Disability Index (ODI). Secondary outcomes include changes in the Numeric Rating Scale (NRS) and the modified Schober test.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Chronic low back pain due to facet joint arthropathy is a common cause of disability.

Fluoroscopy-guided facet joint blocks are widely used in standard practice, but evidence quantifying objective functional and biomechanical recovery beyond pain reduction is limited.

This single-center, prospective, observational, longitudinal study aims to objectively quantify functional recovery. Forty patients aged 18-75 years with clinically and radiologically confirmed lumbar facet syndrome will be observed. The intervention (unilateral fluoroscopy-guided injection of ropivacaine 0.2% [0.5-1 mL] and methylprednisolone into the affected facet joint) is performed strictly as part of routine clinical care, independent of study inclusion.

Assessments occur at baseline (T0) and 30 days post-injection (T1). The primary outcome is the change in Oswestry Disability Index (ODI) score. Secondary outcomes are changes in Numeric Rating Scale (NRS) pain scores and the modified Schober test (cm). Adverse events and procedural safety are recorded. The study aims to provide preliminary effect estimates to inform future controlled trials.

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 墨西哥
    • Mexico City
      • Mexico City、Mexico City、墨西哥、03229
        • Centro Médico Nacional 20 de Noviembre, ISSSTE
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults aged 18-75 years with chronic low back pain (>3 months) due to lumbar facet syndrome confirmed by clinical examination and imaging, presenting to the Algology outpatient clinic.

描述

Inclusion Criteria:

  • Age 18-75 years
  • Clinical and radiological diagnosis of lumbar facet syndrome
  • Low back pain duration >3 months
  • Baseline NRS pain score ≥4/10
  • Signed informed consent for the procedure and study participation
  • Cognitive capacity to independently complete the Oswestry Disability Index

Exclusion Criteria:

  • Radicular pain or confirmed disc herniation with neural compression
  • Coagulopathy or use of anticoagulants not discontinued appropriately
  • Active systemic or local infection
  • Known allergy to local anaesthetics or corticosteroids
  • Pregnancy or lactation
  • Previous lumbar spine surgery at the same level
  • Inability to comply with follow-up schedule

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Facet Block

Single group receiving standard-of-care fluoroscopy-guided lumbar facet joint injection of ropivacaine 0.2% (0.5-1 mL) and methylprednisolone into the affected facet joint(s).
程序：Fluoroscopy-guided lumbar facet block

Under fluoroscopic guidance, a 20G Quincke needle is placed into the target lumbar facet joint or onto the adjacent medial branch. An arthrogram is performed with 0.3 to 0.5 mL of non-ionic contrast to confirm correct dispersion and exclude vascular/intrathecal uptake. Subsequently, 0.5 to 1 mL of a mixture containing ropivacaine 0.2% and methylprednisolone is injected per level. Performed on an outpatient basis under standard monitoring.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Oswestry Disability Index (ODI)
大体时间：Baseline (pre-injection) and 30 days post-injection

The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures functional disability in daily activities (0% = no disability, 100% = severe disability). The primary outcome is the change in ODI score from baseline to 30 days. A reduction of ≥10 points is considered clinically significant.
Baseline (pre-injection) and 30 days post-injection

次要结果测量

结果测量
措施说明
大体时间
Change in Numeric Rating Scale (NRS) pain score
大体时间：Baseline, immediately post-procedure, and 30 days post-injection

Pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). A clinically significant reduction is defined as at least a 50% decrease from the baseline score.
Baseline, immediately post-procedure, and 30 days post-injection
Change in modified Schober test (lumbar flexion mobility)
大体时间：Baseline and 30 days post-injection

The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range.
Baseline and 30 days post-injection
Incidence of adverse events
大体时间：Immediately after procedure up to 30 days post-injection

Record of any adverse events including pain at injection site, transient exacerbation of pain, allergic reaction, inadvertent dural puncture, spinal haematoma, or nerve root injury.
Immediately after procedure up to 30 days post-injection

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

合作者

ISSSTE Centro Médico Nacional 20 de Noviembre

调查人员

  • 首席研究员：Sergio Tenopala Villegas, MD、Centro Médico Nacional 20 de Noviembre, ISSSTE
  • 副研究员：Paola Estefania Vallejo Mora, MD、Centro Médico Nacional 20 de Noviembre, ISSSTE

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月5日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • RAI.CMN.373.2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in this study, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository.

IPD 共享时间框架

Beginning at the time of article publication, with no end date.

IPD 共享访问标准

Data and code will be publicly available with no access restrictions via GitHub.

IPD 共享支持信息类型

  • 研究方案
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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