low back pain. Low back pain
Conditions
Interventions
Intervention 1: In intervention group 10 ml Ropivacaine 0.2% ( produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen, Iran) ,50 mg Magnesium sulfate (produced by Shahid Ghazi,Iran) and 1500 uni
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Chronic low back pain more than six months +/- radiculopathy Moderate to severe pain score (> 3, based on the Visual Analog Scale) Being at the age of 40-70 years Inadequate response to conservative and physiotherapy treatments after three months American Anesthesiologists Classification (ASA) I-II Disc protrusion in MRI
Exclusion criteria
Exclusion criteria: Severe canal stenosis (more than two thirds in axial MRI view) Sequestrated disc (fragmented) Decreased disc height more than 60% Sever spinal deformity Spinal tumors Vertebral fracture Spondylolisthesis Grade>2 Local or systemic infection Taking anticoagulants Drug abuse History of drug reaction Sever psychological disorders Pregnancy and lactation Severe or sudden neurological deficit such as urinary or fecal incontinence Body Mass Index (BMI) > 35 Patient's refusal Diabetes mellitus MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips) Impossible prone positioning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain. Timepoint: Before injection,two weeks,1,3 and 6 months after intervention. Method of measurement: pain score measured with visual analogue scale in Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional disability Index. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Oswestry Disability Index questionnaire (ODI).;Raising straight leg, raising straight leg reversely. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: straight leg raising test (SLR) ,Reverse straight leg raising test (RSLR).;Bonnet. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;FABER. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;Gaenslen. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;Tiptoe and Heel walking. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;Visual Analogue Pain scale. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;Analgesic consumption. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.;Blood sugar. Timepoint: Blood sugar ,before injection,2 th day and 2th week after injection. Method of measurement: The result of the tests.;HbA1C. Timepoint: injectionHbA1C, before injection,3 and 6 month after injection. Method of measurement: The result of the tests.;Spinal canal diameter changes at MRI. Timepoint: MRI, before injection and 6 month after injection. Method of measurement: MRI report. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarnad Imani
Iran University of Medical Sciences
Outcome results
None listed