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IRCT20180603039966N3 IRCT 2023-12-03 Shahid Beheshti University of Medical Sciences New technique in intradiscal injection Fluoroscopy- guided intradiscal Radiopaque Gellified Ethanol injection using the anteroposterior view in comparison to oblique view – A Randomized Trial 2023-12-21 anticipated 70 Complete https://irct.ir/trial/73956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomized to treatment groups using a blocked randomization scheme with block sizes of 4, this means that participants were divided into blocks of four, and then each participant within a block was randomly assigned to one of the treatment groups. In this design, patients are randomly divided into 18 groups of four. Then, in each block that includes 4 patients, each injection technique is assigned equally among these four patients. In this way, each injection technique in each block is equally given to four subjects, Blinding description: In this study, the person who is recording the time of the procedure and the exposure dosage is unaware of the technique used. For the person analyzing the information, the two groups are reported as groups A and B. Group A will be related to the Anterior-Posterior technique and Group B will be related to the Oblique technique. N/A Intervertebral disc disorders with radiculopathy, lumbar region. Intervention 1: Intervention group: In AP view technique, the entry point at which the needle penetrates, is measured through the use of a ruler feature in the MRI images software. In axial image, the line is drawn from center of the disc, passing the ateral border of superior articular process (SAP), to the surface of the skin, then the distance between the entry point and midline will be measured with the software. In AP technique, the desired injection level has been determined using an AP view with a C-Arm device. The procedure takes place under local anesthesia, with 1% lidocaine administered to numb the area. An 18 G Chiba needle is then inserted into the designated point at a distance of approximately 8-10 cm from midline(in accordance to MRI measurement), with 45 degrees angle, after penetration the needle is advanced into the skin until the tip of the needle ultimately hit against lower vertebrae's SAP. Then the needle will be walked off over the SAP, through the Kambine’s triangle. As we cautiously advance using stepwise movements until the tip of the needle passes medial border of the SAP in AP view, the C-Arm device will be rotated for a true lateral view to control the depth of the needle, we will advanced the needle until hitting resistance, and penetrated through the disc. The needle will be andvanced until the tip is center of the intervertebral disc. Intervention 2: Control group: In the oblique technique, in order to ascertain precise accuracy throughout this process, every patient's injection site anatomy as well as the needle's trajectory path are determined through guidance provided by C-arm imaging. Once these factors have been meticulously identified, we proceed by squering involved vertebrae, then utilizing an oblique view. Within this viewpoint, we carefully select an appropriate point on the skin for needle insertion before delicately introducing an Chiba 18G needle into target disc. As soon as we reach beyond the medial border of the pedicle in anteroposterior (AP) view, confirmation is sought via lateral view analysis. Upon receiving confirmation through this holistic assessment approach and having successfully located our target within center of the intervertebral disc further advancement ceases accordingly at that particular point of penetration with regards to needle tip placement. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sina Hassannasab
Arghvan building, Mehrangar 6, Sayad 8
Gorgan Iran (Islamic Republic of) 4917964313 +98 911 313 3385 sina.hasannasab@yahoo.com Shahid Beheshti University of Medical Sciences scientific Sina Hassannasab
Arghavan Apt., Mehrnegar 6 St. Sayyad 8 St.
Gorgan Iran (Islamic Republic of) 4917964313 +98 911 313 3385 sina.hasannasab@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) consent to participate individuals suffer from grade I and II herniated disc spinal canal stenosis of less than 30% as determined by clinical examinations and MRI findings chronic back pain for more than six months symptomatic disc herniation radial foot pain on one or both sides no axial pain do not have degenerative disc disease no history of RGE injection in the last six months no opioid usage no coagulation disorder not being pregnant no history of malignancy no history of spinal deformities, prior spine surgeries, traumatic injuries causing vertebral fractures, or infections in the vertebrae lumbar disc herniation in L3 and/or L4 no history of neurological impairments no history of psychiatric problems 18 years no limit Both Unexpected allergy to antiseptic agents Unexpected allergy to local anesthetics Unexpected allergy to intravenous sedatives M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Other Treatment - Other Intervention group: In AP view technique, the entry point at which the needle penetrates, is measured through the use of a ruler feature in the MRI images software. In axial image, the line is drawn from center of the disc, passing the ateral border of superior articular process (SAP), to the surface of the skin, then the distance between the entry point and midline will be measured with the software. In AP technique, the desired injection level has been determined using an AP view with a C-Arm device. The procedure takes place under local anesthesia, with 1% lidocaine administered to numb the area. An 18 G Chiba needle is then inserted into the designated point at a distance of approximately 8-10 cm from midline(in accordance to MRI measurement), with 45 degrees angle, after penetration the needle is advanced into the skin until the tip of the needle ultimately hit against lower vertebrae's SAP. Then the needle will be walked off over the SAP, through the Kambine’s triangle. As we cautiously advance using stepwise movements until the tip of the needle passes medial border of the SAP in AP view, the C-Arm device will be rotated for a true lateral view to control the depth of the needle, we will advanced the needle until hitting resistance, and penetrated through the disc. The needle will be andvanced until the tip is center of the intervertebral disc. Control group: In the oblique technique, in order to ascertain precise accuracy throughout this process, every patient's injection site anatomy as well as the needle's trajectory path are determined through guidance provided by C-arm imaging. Once these factors have been meticulously identified, we proceed by squering involved vertebrae, then utilizing an oblique view. Within this viewpoint, we carefully select an appropriate point on the skin for needle insertion before delicately introducing an Chiba 18G needle into target disc. As soon as we reach beyond the medial border of the pedicle in anteroposterior (AP) view, confirmation is sought via lateral view analysis. Upon receiving confirmation through this holistic assessment approach and having successfully located our target within center of the intervertebral disc further advancement ceases accordingly at that particular point of penetration with regards to needle tip placement. Radiation exposure. Timepoint: Is mesured during the application of intervention. Method of measurement: Dose area product (DAP) meters are utilized to evaluate patient dose by employing an ionization chamber positioned on the collimator of the X-ray tube. Procedure duration. Timepoint: The Procedure Time(PT) is carefully measured, beginning when the first fluoroscopic image was taken and ending only when the needle tip accurately reached its intended target point within the nucleus pulposus. Method of measurement: chronometer. Shahid Beheshti University of Medical Sciences Approved 2023-11-12 Shahid-Beheshti Medical University Ethics Committee Shahid Chamran Highway - Yemen St. - Arabi St., Shahid Beheshti University of Medical Sciences and Healthcare Services - building number two of the university headquarters - 6th floor tehran Tehran Iran (Islamic Republic of)