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IRCT201610177984N26 IRCT 2017-02-12 Vice chansellor for research, Iran University of Medical Sciences effect of ozone on low back pain. none Comparison of transforaminal ozone injection Vs triamcinolon infilteration on chronic radicular low back pain. 2016-01-01 anticipated 64 Complete https://irct.ir/trial/8440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A low Back Pain. Intervention 1: (10ml of 30micro/ml ozone +5ml bupivacaine 0.2%)per root. Intervention 2: 20mg triamcinolone +5ml bupivacaine 0.2% per root will inject.
public Farnad Imani
Hazrat Rasui Medical Complex, Niayess st, Sattar Khan Ave.
Tahran Iran (Islamic Republic of) +98 21 6435 2326 farnadimani@yahoo.com Hemmat Highway Iran University of Medical Sciences scientific Farnad Imani
Anesthesia and pain department of Hazrat Rasul Medical complex, Niayesh st, Sattar-Khan avenue.
Tahran Iran (Islamic Republic of) 1445613131 +98 21 6435 2326 farnadimani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria including: Radicular LBP that persistent more than 6 weeks; Root impression due to disc bulging or foraminal narrowing that confirmable in MRI; The patient age must be between 18 -70 yr old; Physical status level I to II according to ASA physical status classification system. Valid, written consent to participate in study must be obtained; Pain score must be more than 4 according to numerical rating scale(NRS)tool; Lack of pain relieve to medication and physical therapy; Three or less nerve root must be involved. Exclusion criteria including: If coagulopathy to exist; presence of systemic or zone of needle entry point infection; Severe anatomical distortion(for example scoliosis); presence history of back surgery or device implantation; Severe psychotic disorder is co-exist; history of allergy to local anesthetics is positive; if progressive deficiency or motor deficit to exist; If malignancy, pregnancy, or history of substance abuse, HIV and /or chronic hepatitis marker positive to exist; If acute trauma; or cauda equina syndrome to exist. 18 years 70 years Both M54.4 low Back Pain with Sciatica Treatment - Surgery Treatment - Surgery (10ml of 30micro/ml ozone +5ml bupivacaine 0.2%)per root. 20mg triamcinolone +5ml bupivacaine 0.2% per root will inject Pain. Timepoint: befor itervention will started,and the end of weeks two and four months three and six. Method of measurement: Nnmrical Rating Scale tool of pain. Chronic pain biomarker, TNFalpha in serum. Timepoint: befor itervention will started,and the end of month two. Method of measurement: Venous Blood sample. Root Impression in MRI. Timepoint: Before intervention and the end of second month. Method of measurement: MRI imagine. Disability. Timepoint: befor intervention will start,the end of weeks two and four,months three and six. Method of measurement: Oswestry Disability Questionnaire. Labratory data, BUN, Cr, Bs. Timepoint: befor intervention will start,the end of weeks two and four,months three and six. Method of measurement: Venous blood sample. Dermatomal pain distribiotion,posetive SLR(and degree of), revres SLR. Timepoint: before intervention will start,the end of weeks two and four,month three and six. Method of measurement: Pain that induced with physical examination and it's distribution,degree of range of motion that induced pain,. Vice chansellor for research, Iran University of Medical Sciences Approved 2016-09-18 Ethic Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Expressway corner Tehran Iran (Islamic Republic of)