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IRCT20131124015515N3 IRCT 2018-12-08 Shahid Beheshti University of Medical Sciences Effect of Corticosteroid injection in Epidural Space in patients with Lumbar Disc Herniation Comparison of the Effect of Epidural Corticosteroid Injection on Obese and Non-Obese Patients with Lumbar Disc Herniation 2018-11-30 anticipated 150 Complete https://irct.ir/trial/35555 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 Hernia Disc Lumbar with radiculopathy. Intervention group: Epidural steroid injection with 2 ml bupivacaine 2% and 6 ml distilled water and 40 mg / ml triamcinolone (total volume 8 ml) in the target area.. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Seyed 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 Seyed 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) Patients older than 18 years Hernia disc and in case of stenosis of spinal cord involvement less than 30% based on clinical examinations and CT scan/MRI findings Symptomatic hernia, leg pain and unilateral radiculopathy Lumbar Disc Patients are candidates for epidural steroid injection Signed written informed consent to participate in the study 18 years no limit Both Body Mass Index <20 kg/m2 Disc herniation at levels other than L4 to S1 Central hernia with extrusion pain or symptoms of progressive or severe sensory impairment More than two hernia discs at different levels of the lumbar History of steroid epidural injection in the last six months History of opioid abuse The latest use of long-acting opioids with radicular pain for more than a year Coagulation disorders, Steroid susceptibility, Malignancy Psychiatric problems and patient's lack of cooperation, speech problems Surgical indication, local skin infections in the area of operation, deformity of the spine and pregnancy History of lumbar spine surgery, cauda equina syndrome, vertebral fracture, tumor or infection in the spine, inflammatory spondylopathy, neurological defects M51.16 Intervertebral disc disorders with radiculopathy, lumbar region. Treatment - Drugs Intervention group: Epidural steroid injection with 2 ml bupivacaine 2% and 6 ml distilled water and 40 mg / ml triamcinolone (total volume 8 ml) in the target area. Pain Level. Timepoint: Before treatment, two, and six weeks 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, two, and six weeks 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 2017-10-27 Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services Bone and Joint Diseases Research CenterÙˆ Akhtar Hospital, Sharifi Manesh st. Tehran Tehran Iran (Islamic Republic of)