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Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain

2026年7月30日 更新者：EPC Education s.r.o.

Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study

Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation (BVNA) for Axial Low Back Pain treatment, including the method optimization.

Description of Clinical State:

The basivertebral nerve is a small nerve (or rather a nerve fiber) located within the vertebral bodies, responsible for transmitting pain signals from a degenerated disc. Basivertebral nerve ablation is a minimally invasive procedure consisting of the interruption of the basivertebral nerve fibers that conduct pain.

Description of interventional procedures:

The BVNA procedure is performed under sterile conditions in an interventional suite by an experienced physician under fluoroscopic (X-ray) guidance. Following local anesthesia of the skin and subcutaneous tissue, a working instrument (cannula) is inserted into the affected vertebral body, guided by the patient's individual anatomy and preoperative Magnetic Resonance Imaging (MRI) planning. Subsequently, a radiofrequency electrode is introduced into the central part of the vertebral body. Through this electrode, targeted thermal energy is applied, leading to the interruption of pain signal transmission from the basivertebral nerve. Both the temperature and the duration of the application are strictly controlled. The patient remains conscious or under light sedation throughout the procedure and is continuously monitored and questioned regarding any discomfort, particularly pain or sensations of heat. Upon completion of the procedure, the electrode and the working instrument are removed, the puncture site is treated with a sterile dressing, and the patient is typically discharged to home care after a brief postoperative observation period. During the follow-up period, the patient will be asked to complete standardized questionnaires (Numeric Rating Scale (NRS) for Pain; Pain, Enjoyment of Life, and General Activity (PEG) Assessment; Global Rating of Change (GRC); The Oswestry Disability Index (ODI); EQ-5D Standardized Questionnaire used to measure Health-related Quality of Life) assessing pain intensity, functional limitations, and quality of life at intervals of 6 weeks, and 3, 6, and 12 months post-procedure, and long-term (24 months and beyond) depending on capacity. The follow-up also includes a control MRI scan approximately 6 months after the procedure.

研究类型

介入性

注册 (估计的)

100

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。

学习联系方式

学习地点

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:

  • Axial low back pain (with or without lateral component).
  • Presence of Modic type I or II changes at ≥ 1 level.
  • Age over 18 years.
  • Duration of pain ≥ 6 months.
  • Completion of full conservative management for ≥ 3 months.
  • Medial Branch Block (MBB) test performed with negative results/ or Facet Denervation done with unsatisfactory outcome (less than 50% improvement) after positive MBB test.

Exclusion Criteria:

  • Coagulation disorders.
  • Platelet abnormalities.
  • Lack of informed consent.
  • Generalized solid tumor.
  • Hematopoietic malignancy.
  • Radicular pain.
  • Alternative primary pain generators other than axial low back pain.
  • Previous spinal surgery.
  • Targeted level located above L3/L4
  • Osteoporosis

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：BVN ablation
程序：BVN ablation
intraosseal monopolar basivertebral nerve ablation

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
The Oswestry Disability Index (ODI)
大体时间：6 weeks, and 3, 6, 12 months
Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
6 weeks, and 3, 6, 12 months

次要结果测量

结果测量
措施说明
大体时间
Numeric Rating Scale (NRS) for Pain
大体时间：6 weeks, and 3,6,12 months
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
6 weeks, and 3,6,12 months
EQ-5D standardized questionnaire used to measure health-related quality of life
大体时间：6 weeks, and 3, 6 12 months
Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
6 weeks, and 3, 6 12 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
大体时间：6 weeks, and 3, 6 12 months
Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
6 weeks, and 3, 6 12 months
Global Rating of Change (GRC)
大体时间：6 weeks, and 3, 6 12 months
retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
6 weeks, and 3, 6 12 months

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

EPC Education s.r.o.

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 (实际的)

2026年5月4日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • KS_EPCcz_2026/001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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