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IRCT20131124015515N7 IRCT 2019-07-28 Shahid Beheshti University of Medical Sciences Comparison of the Effect of Hyaluronidase and Hypertonic Saline 5% on Removal lumbar spinal space adhesion Comparison of hyaluronidase Vs. hypertonic saline 5% effects in Percutaneous Caudal Epidural Adhesiolysis With the Racz Technique for patients with Failed Back Surgery Syndrome 2019-07-31 anticipated 60 Complete https://irct.ir/trial/40999 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on random numbers table, in this method, we set a set of numbers without a specific pattern and order, and completely randomly in the table, we will read the table numbers from the direction above. For the intervention group, we consider the even numbers and the control group for the odd numbers. Then put on one of the numbers and move upwards, register the number and assign one to an intervention or control group, Blinding description: Participant and clinical outcomes evaluator are not aware of the code assigned to each of the groups. 2-3 Failed Back Surgery Syndrome. Intervention 1: Intervention group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of saline solution with 1500 IU of hyaluronidase, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter. Intervention 2: Control group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of hypertonic saline 5%, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Only available to scholars working in academic and academic institutions Conditions: Employed in research centers Where to obtain: Person responsible for scientific inquiries How to obtain: Send email to person responsible for scientific inquiries Comments:
public Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 and above Epidural Adhesion Detection Based on Clinical and MRI Findings History of spinal surgery History of chronic low back pain after surgery for more than six months Radicular or axial back pain Herniated disk Patients with satisfaction to participate in the study 18 years no limit Both Facet joint arthritis History of epidural injection or other invasive treatments in the last six months Severe central lumbar canal stenosis Stenosis caused by scoliosis Lumbar disc degenerative Sacroiliac joint disease Severe cardiopulmonary disease, uncontrolled diabetes, obesity History of misuse of any type of narcotic, opioid and alcohol Pregnancy, breastfeeding Psychiatric problems and patient's lack of cooperation, speech problems Surgical indication Topical skin infections in the area of the surgery Coagulation disorder Contraindication for Epidural Lumbar Injection Patients dissatisfied with participation in the study M96.1 Postlaminectomy syndrome, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of saline solution with 1500 IU of hyaluronidase, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter. Control group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of hypertonic saline 5%, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter. Pain Level. Timepoint: Before treatment, one, three and six months after treatment. Method of measurement: visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe). Disability Level. Timepoint: Before treatment, one, three and six months after treatment. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability. Shahid Beheshti University of Medical Sciences Approved 2019-05-04 Ethics committee of Shahid Beheshti University of Medical Sciences Tabnak St.,Tehran, Tehran, Iran, Islamic Republic Of Tehran Tehran Iran (Islamic Republic of)