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A comparison of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain.

Phase 3
Recruiting
Conditions
low back pain.
Low back pain
Registration Number
IRCT20111102007984N28
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

1) Chronic low back pain more than six months +/- radiculopathy, 2) Moderate to severe pain score (> 3, based on the Visual Analog Scale),3) Age 40-70 years,4) Inadequate response to conservative and physiotherapy treatments after three months,5) ASA classification I-II,6) Disc protrusion (at MRI)

Exclusion Criteria

1) Severe canal stenosis (more than two thirds in axial MRI view), 2) Sequestrated disc (fragmented),3) Decreased disc height more than 60%,4) Sever spinal deformity,5) Spinal tumors,6) Vertebral fracture,7) Spondylolisthesis > Grade II, 8) Local or systemic infection, 9) Taking anticoagulants,10) Drug abuse,11) History of drug reaction,12) Sever psychological disorders,13) Pregnancy and lactation,14) Severe or sudden neurological deficit such as urinary or fecal incontinence,15) Body Mass Index (BMI) > 35,16) Patient's refusal,17) Diabetes mellitus, 18) MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips),19)Impossible prone positioning

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ow back pain. Timepoint: Before injection,two weeks,1,3 and 6 month after intervention. Method of measurement: pain score measured with visual analogue scale in Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Oswestry Disability Index questionnaire (ODI) and straight leg raising test (SLR), Reverse straight leg raising test (RSLR),Bonnet,FABER,Gaenslen,Tiptoe and Heel walking,analgesic consumption,blood sugar,HbA1C,MRI. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Blood sugar ,before injection,2 th day and 2th week after injectionHbA1C, before injection,3 and 6 month after injection MRI, before injection and 6 month after injection. Method of measurement: Questionnaire.
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