Romano 2009.
Methods | Randomised, double‐blind, cross‐over (4 weeks each treatment, with 1 week washout) | |
Participants | Chronic low back pain of at least 6 months' duration, due to disc prolapse, lumbar spondylosis, and/or spinal stenosis. Pain intensity > 40/100 mm N = 42, age 18 to 75 years Results reported according to LANSS score (non‐neuropathic <12; neuropathic ≥12) |
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Interventions | Celecoxib 3 to 6 mg/kg/day Pregabalin 1 mg/kg/day for 1 week than 2 to 4 mg/kg/day Treatment groups: celecoxib alone, pregabalin alone, celecoxib + pregabalin |
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Outcomes | Self‐reported VAS (0 to 100 mm) Withdrawals, adverse events |
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Notes | Oxford Quality Score: R = 2, DB = 1, W = 1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to pre‐ordered sequence based on consecutive recruitment order |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, but method not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data on 36 completers of 42 |
Selective reporting (reporting bias) | Low risk | No problems detected |
Size | High risk | 36 completers (16 with neuropathic pain according to LANSS criteria) |