跳至主要内容
临床试验/NCT04528875
NCT04528875Unknown不适用

Augmenting Ultrasound Imaging in Order to Replace Fluoroscopy in Image Guided Pain Procedures

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Algorithm for imaging augmentation of ultrasound

研究概览

简要总结

Utilizing existing data from CT/MRI images of patients, the investigators wish to develop an algorithm for augmenting the image obtained by ultrasound. In order to improved injection by ultrasound guidance

详细描述

Introduction:

A large proportion of injection-guided injections for pain relief including the lower back are performed with fluoroscopy. Performing the injection requires an adapted room, a fluoroscope with a C-shaped arm (c-arm), an X-ray technician, a physician, and a nurse. The amount of radiation, which is ionizing, is not negligible and depends very much on the reliability of the medical team. The injections performed in this technique include injections into the epidural space, injections into the facet joints (joints between the vertebrae of the back), nerve blocks, and radiofrequency nerve ablation.

Using ultrasound imaging, as a substitute for fluoroscopy, may help real-time guidance of needle placement, and allow imaging from multiple directions, without ionizing radiation that endangers the patient and caregivers, while reducing treatment. costs The use of ultrasound imaging will allow these treatments to be performed in outpatient clinics as well, without the need for expensive equipment.

Nowadays, with the existing ultrasound equipment, there is a very high variability as to the quality of the image obtained while scanning the lower back. Poor image quality makes it very difficult to perform an accurate and reliable injection. In contrast, the structures of the lower back can be optimally simulated using CT (mainly the skeletal structures such as vertebrae and joints) and using MRI (better resolution for soft tissue structures than for skeletal structures). Performing invasive injections under the guidance of these measures is costly both in terms of equipment and in terms of manpower and certainly contributes to ionizing exposure in the case of CT. At the same time, many patients come to the Institute of Pain Medicine, after performing these imaging tests.

The investigators intend to develop an algorithm in which these tests (CT, MRI) will serve as a database for each patient participating in the study whose back will be scanned using an ultrasound transducer. According to the initiators of the study, the investigators can develop an imaging application that will rely on both the information of an imaging image of CT and / or MRI and after the back scan (using an ultrasound transducer) the investigators will get an improved (augmented) ultrasound image that can be used in the future as an ultrasound-guided injection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with low back pain including lower / upper back pain. Patients who underwent MRI or CT imaging of the lower back during the past year.
  • Patients who can understand the rationale of the study and can sign an informed consent form.

排除标准

  • Patients who have undergone back surgery in the lower back area Patients with significant deformity (deformity) in the back such as scoliosis with an angle above 50 degrees

结局指标

主要结局

Algorithm for imaging augmentation of ultrasound

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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