Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04528875
Status:
UNKNOWN
Last Update Posted:
2021-03-12
First Post:
2020-08-23
Brief Title:
Augmenting Ultrasound Imaging in Order to Replace Fluoroscopy in Image Guided Pain Procedures
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Augmenting Ultrasound Imaging in Order to Replace Fluoroscopy in Image Guided Pain Procedures
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Utilizing existing data from CTMRI 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
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 hospitals 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
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 hospitals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None