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IRCT20181011041308N3 IRCT 2020-11-27 Iran University of Medical Sciences *Efficacy of transforaminal hyaluronidase versus transforaminal ozone in herniated lumbar disc pain *Efficacy of transforaminal hyaluronidase versus transforaminal ozone in herniated lumbar disc pain 2020-03-19 anticipated 45 Complete https://irct.ir/trial/46164 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: 45 patients suffering from radicular low back pain, allocated into tree groups.1_group TH received triamcinolone 20 mg,ropivacaine 0/2% 3cc,hyaluronidase 1500 units 2_group TO received triamcinolone 20 mg,ropivacaine 0/2% and ozone 39 macro 5cc3_group HO received triamcinolone 20 mg, ropivacaine 0/2% 3cc ,hyaluronidase 1500 units and ozone 39 macro 5cc. After transferring patients to the interventional pain procedure room, hydration achieved using normal saline 500cc .patient was placed in a prone position and the back was prepped .local anesthesia was achieved by subcutaneous administration of 3cc lidocaine 1% injection. Then transforaminal lumbar epidural injection was done. the patients were then transferred to the pre-anesthesia care unit for monitoring vital signs, pain scores and, neurological adverse events. They were then discharged home in the care of a responsible adult. Pain score (VAS), Oswestry disability index (ODI) and consumed- drugs, measured after 2 weeks, one month, 2months and 3 months, Randomization description: The patients randomly allocated into three groups. This study is a double-blind study, Blinding description: The patients and physicians don't have information about injected drugs. 3 lumbar radicular pain. Intervention 1: Control group: transforaminal hyaluronidase received triamcinolone 20 mg,ropivacaine 0/2% 3cc,hyaluronidase 1500 units. Intervention 2: Intervention group: group TO:received triamcinolone 20 mg,ropivacaine 0/2% and ozone 39 macro 5cc3. Intervention 3: Intervention group: received triamcinolone 20 mg, ropivacaine 0/2% 3cc ,hyaluronidase 1500 units and ozone 39 macro 5cc. Yes - There is a plan to make this available What will be shared: information about the main and secondary outcomes When: start the access period immediately after printing the results To whom: only individuals and academic institutions Conditions: The result of any analysis without harmonization and permission is not published Where to obtain: alebuieh.mr@iums.ac.ir How to obtain: The request from the academic university will be answered within ten business days. Comments:
public Dr Mahmoodreza Alebouyeh
Interventional pain operation room,Rasool Akram hospital,Niyayesh street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2107 alebuieh.mr@iums.ac.ir Iran University of Medical Sciences scientific Dr Mahmoodreza Alebouyeh
Interventional pain operation room,Rasool Akram hospital,Niyayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2107 alebuieh.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Radicular lumbar pain for more than 6 months Disc protrusion One or two levels are involved No response to conservative therapy for 3 months Pain score more than 3 20 years 60 years Both Patient,s discontent ASA more than 2 Spine deformity Vertebral listhesis ,grade 2 or more Lumbar spine surgery Anti coagulation therapy Drug and alcohol abuse Drug allergic reactions Local or systemic infection Pregnancy MRI contraindications Severe pulmonary disease Severe psychiatric disease Peripheral neuropathy Spine fracture G54.1 Lumbosacral plexus disorders Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: transforaminal hyaluronidase received triamcinolone 20 mg,ropivacaine 0/2% 3cc,hyaluronidase 1500 units Intervention group: group TO:received triamcinolone 20 mg,ropivacaine 0/2% and ozone 39 macro 5cc3 Intervention group: received triamcinolone 20 mg, ropivacaine 0/2% 3cc ,hyaluronidase 1500 units and ozone 39 macro 5cc Visual Analog Scale. Timepoint: 2 weeks-1 month- 2 months-3 months. Method of measurement: asking from patient. Oswestry Disability Index. Timepoint: 2 weeks-1 month-2 months -3 months. Method of measurement: asking from patient. Consumed- drugs. Timepoint: 2 weeks-1 month-2 months -3 months. Method of measurement: asking from patient. Iran University of Medical Sciences Approved 2020-10-18 Ethics committee of Iran University of Medical Sciences Hemmat Highway Tehran Tehran Iran (Islamic Republic of)