Balakrishnamoorthy 2015.
Study characteristics | ||
Methods | Clinical setting: emergency room Number randomized: 58 Number analyzed: 36 Attrition: 38% Funding source: none reported Country: Australia Publication language: English |
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Participants | Mean age: 39 years with corticosteroid vs 37 years with placebo Women: 59% with corticosteroid vs 45% with placebo Race: not reported Type of back pain: radicular (not due to spinal stenosis) Duration of symptoms: not reported Baseline pain (VAS, scale 0–10): 8.1 with corticosteroid vs 7.0 with placebo Baseline function (ODI, 0–100): 62 with corticosteroid vs 63 with placebo No imaging correlation required |
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Interventions | Dexamethasone 8 mg (50 mg prednisone equivalents) IV (29 participants) Placebo (29 participants) Duration of treatment: single dose Duration of follow‐up: 6 weeks |
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Outcomes | Pain: VAS (scale 0–10) Disability: ODI (scale 0–100) Disability (dichotomous): ability to resume normal activities Any adverse event Serious adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated. |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo. |
Blinding of care provider | Low risk | Placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant filled data sheets placed in locked box. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition 38% (22/58) at 6 weeks. |
Selective reporting (reporting bias) | Low risk | Primary outcomes described and reported. |
Baseline group similarity | Unclear risk | Groups not similar at baseline. |
Co‐interventions avoided or similar | Low risk | No issues noted. |
Acceptable compliance | Low risk | No issues noted. |
Intention to treat | Low risk | Intention‐to‐treat analysis. |
Timing of outcome assessment similar | Low risk | Timing of outcome assessment similar. |