ACTRN12611001020976RecruitingPhase 4
The Effect of a Single Dose Intravenous Dexamethasone Compared to Placebo on Visual Analogue Pain Scores in Patients with Low Back Pain and Radiculopathy Presenting to the Emergency Department
Dr Gerben Keijzers0 sites100 target enrollmentStarted: September 22, 2011Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •(1) Low back pain with radiculopathy – Defined as a history of a dermatomal distribution of pain, an increase in pain on coughing, sneezing, or straining, paroxysmal pain, and predominant leg pain
- •(2) Straight leg test positive - The straight leg raise test is deemed to be positive when there is reproduction of pain in the sciatic nerve distribution of the affected leg between 0 to 70 degrees, with the patient in the supine position with no pillow, a flat bed in 180 degrees horizontal, with the patient’s head and pelvis in the 180 degrees horizontal plane.
- •(3) Unable to mobilize safely without assistance
Exclusion Criteria
- •(1) Declines intravenous cannulation
- •(2) Below 18 or over 55
- •(3) People with intellectual or mental impairment
- •(4) Allergy to dexamethasone or NS
- •(5) Red flags: fever, history of malignancy, recent significant trauma, ectopic pregnancy
- •(6) Medical conditions were steroids are contraindicated or are being given (current asthma using oral steroids, body builders using anabolic steroids)
- •(7) History of lower back surgery
Investigators
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