Hosie 1993.
Methods | R, DB, AC, parallel groups Foam (approximately the size of a golf ball) applied, and 1 tablet taken, 3 times daily for 7 days and up to 14 days Assessed at baseline, 7, 14 (if necessary) days |
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Participants | Acute lower back injury (< 1 month) N = 287 (261 analysed for efficacy) M 151, F 136 Mean age 37 years (range 18 to 63) Most participants had moderate to severe pain on movement, one had none Exclusions: 25 lost to follow up, one assessed at 14 days, but not 7 days |
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Interventions | Felbinac foam 3%, 3 x 2 g daily + placebo tablets, 3 x 1 daily, n = 140 (127 analysed for efficacy) Ibuprofen tablets, 3 x 400 mg daily + placebo foam, 3 x 2 g daily, n = 147 (134 analysed for efficacy, but one had no pain at baseline) No other oral, injectable, or topical analgesic or anti‐inflammatory medication. Ongoing physiotherapy to continue without change |
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Outcomes | Pain on movement: 5‐point scale (responder = "none" or "mild") Spontaneous pain: 5‐point scale (responder = "none" or "mild") Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "double dummy" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Imputation method not mentioned |
Size | Unclear risk | 50 to 200 participants per treatment arm |