low Back Pain. low Back Pain with Sciatica
Conditions
Interventions
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.
Treatment - Surgery
(10ml of 30micro/ml ozone +5ml bupivacaine 0.2%)per root.
20mg triamcinolone +5ml bupivacaine 0.2% per root will inject
Sponsors
Vice chansellor for research, Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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,. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarnad Imani
Hemmat Highway Iran University of Medical Sciences
Outcome results
None listed