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Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis

2026年5月28日 更新者:Marmara University

Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis

Lumbar spinal stenosis is a common degenerative condition that can cause chronic low back and leg pain, especially during walking or standing. Interlaminar epidural steroid injections are widely used to relieve pain and improve function in patients who do not respond adequately to conservative treatments.

These injections are usually performed under fluoroscopic guidance, which allows accurate needle placement but exposes patients and healthcare providers to ionizing radiation. Ultrasound guidance has emerged as an alternative technique that avoids radiation exposure; however, ultrasound alone may not always confirm correct epidural spread of the injected medication.

This prospective, randomized clinical trial aims to compare two commonly used imaging approaches for interlaminar epidural steroid injections in patients with lumbar spinal stenosis: fluoroscopy-guided injection and ultrasound-guided injection with fluoroscopic confirmation (hybrid technique). The study will evaluate patient satisfaction, radiation exposure, procedure time, technical success, pain relief, and functional outcomes.

The results of this study are expected to help identify the most effective and safe imaging guidance method for interlaminar epidural steroid injections in patients with lumbar spinal stenosis.

研究概览

详细说明

This prospective, randomized clinical trial will compare two imaging guidance strategies for interlaminar epidural steroid injection in adult patients diagnosed with lumbar spinal stenosis. Eligible participants will be randomly allocated into two groups: a fluoroscopy-guided interlaminar epidural steroid injection group and an ultrasound-guided interlaminar epidural steroid injection group with fluoroscopic confirmation of epidural spread (hybrid technique).

All procedures will be performed at a single tertiary care center by experienced clinicians using standardized institutional protocols. In both groups, the interlaminar epidural space will be accessed using a midline or paramedian approach, and the same corticosteroid formulation and injection volume will be administered to ensure treatment consistency.

Procedural outcomes will include total procedure time, fluoroscopy time, radiation dose parameters recorded directly from the fluoroscopy unit, and technical success defined as correct epidural space access with appropriate contrast spread. Radiation exposure will be assessed using dose metrics provided by the imaging system, allowing comparison between the two guidance techniques.

Patient-reported outcomes will be evaluated using validated pain and functional assessment tools at baseline and during routine follow-up visits according to the study protocol. Patient satisfaction will be assessed following the procedure. Adverse events related to the procedure will be documented and monitored throughout the study period.

By systematically comparing these two imaging guidance approaches under standardized clinical conditions, this study aims to clarify whether ultrasound-guided interlaminar epidural steroid injection with fluoroscopic confirmation can reduce radiation exposure while maintaining procedural efficiency, technical accuracy, and clinical effectiveness comparable to conventional fluoroscopy-guided injection.

研究类型

介入性

注册 (估计的)

44

阶段

  • 不适用

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。

学习地点

    • Pendik
      • Istanbul、Pendik、土耳其(türkiye)、34899
        • Marmara University Pendik Training and Research Hospital
        • 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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 40 and 75 years
  • Diagnosis of lumbar spinal stenosis confirmed by clinical evaluation and magnetic resonance imaging (MRI)
  • Presence of neurogenic claudication symptoms for at least 3 months
  • Inadequate response to conservative treatment, including medication, physical therapy, or exercise
  • Numeric Rating Scale (NRS) pain score ≥ 4 at baseline
  • Ability to provide written informed consent

Exclusion Criteria:

  • Previous lumbar spine surgery
  • Vertebral fracture, spinal malignancy, or history of significant lumbar trauma
  • Peripheral vascular claudication or clinically significant peripheral polyneuropathy
  • Epidural steroid injection within the past 6 months
  • Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip/knee osteoarthritis)
  • Pregnancy or breastfeeding
  • Coagulation disorders or inability to safely discontinue anticoagulant or antiplatelet therapy according to guideline recommendations
  • Known allergy to local anesthetics, corticosteroids, or contrast agents
  • Active local or systemic infection
  • Body mass index (BMI) > 30 kg/m²

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
有源比较器:Fluoroscopy-guided lumbar interlaminar epidural steroid injection
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.

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
Patient Satisfaction
大体时间:Immediately after the procedure
Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
Immediately after the procedure
Radiation Exposure
大体时间:During the procedure
Radiation exposure measured as air kerma (mGy) during the procedure.
During the procedure
Procedure Time
大体时间:During the procedure
Procedure time defined as the duration from identification of the target interlaminar space using ultrasound or fluoroscopy to completion of the injection.
During the procedure

次要结果测量

结果测量
措施说明
大体时间
Pain Intensity
大体时间:Baseline, 1 hour, and 3 weeks after the procedure
Pain intensity assessed using the Numeric Rating Scale (NRS).
Baseline, 1 hour, and 3 weeks after the procedure
Functional Status
大体时间:Baseline and 3 weeks after the procedure
Functional status assessed using the Oswestry Disability Index (ODI).
Baseline and 3 weeks after the procedure
Technical Success
大体时间:During the procedure
Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.
During the procedure
Number of Needle Insertions
大体时间:During the procedure
Number of needle insertion attempts required to complete the procedure.
During the procedure
Fluoroscopy Time
大体时间:During the procedure
Total fluoroscopy time automatically recorded by the fluoroscopy unit during the procedure.
During the procedure

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。

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7月1日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年3月12日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared publicly. De-identified aggregate data may be available upon reasonable request, subject to institutional policies and ethical approval.

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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