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

March 9, 2021 updated by: Rambam Health Care Campus
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

The aim of the present study is to improve the quality of the imaging image obtained when scanning the lower back with an ultrasound transducer using the information available from previous imaging images - CT and / or MRI

The study population:

Patients who are referred to the Rambam Institute of Pain Medicine suffering from low back pain and who have already undergone a CT scan or MRI examination of the lower back before arriving at the Institute

Number of participants in this center:

50 patients

Age range:

Between the ages of 18 and 80

Gender:

Without gender restriction

Criteria for inclusion:

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

Criteria for exclusion:

  1. Back surgery in the lower back area
  2. Significant deformity in the back such as scoliosis with an angle above 50 degrees

Criteria for removal from the experiment:

none

The duration of the medical trial includes the follow-up period after the trial:

About a year

Clinical follow-up program (during and after treatment):

A: Patients eligible for the study will receive an explanation and sign a scientific consent form.

B: Subjects will fill out a short demographic questionnaire as well as a questionnaire about their pain problem. Each subject will receive a unique identification number for the study itself.

C: The subjects will be admitted to the Institute of Pain Medicine for the purpose of scanning the back using an ultrasound device. The required imaging acquisition, using the standard transducer (curved array or phased array), is of three scans along the bilateral spine, and three transverse scans in the same area. After scanning - which will take about 5 minutes, the data will be stored in digital media anonymously but with the unique identification number given to the patient in section B.

D: The digital media - CT or MRI will be uploaded to the hospital's imaging archive. Data will be transferred anonymously to external media (disk with a unique identification number of the study only) The digital information of both the ultrasound scan and the previous imaging tests will be transferred to a biotechnology lab, without any identifying details of the patient for analysis.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
        • Principal Investigator:
          • Simon Vulfsons, MD
        • Sub-Investigator:
          • Amir Minerbi, MD
        • Sub-Investigator:
          • Yair Halpern, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are referred to the Rambam Institute of Pain Medicine suffering from low back pain and who have already undergone a CT scan or MRI examination of the lower back before arriving at the Institute

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Algorithm for imaging augmentation of ultrasound
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Simon Vulfsons, M.D., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (ACTUAL)

August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 0266-19-RMB CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Image, Body

Clinical Trials on Ultrasound imaging

3
Subscribe