Morris 1991.
Methods | R, DB, PC, parallel groups Gel applied to site of injury 3 times daily for 7 days Assessed at baseline, 7 days at clinic, and daily patient diary |
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Participants | Acute soft tissue injury (< 3 days) N = 100 (84 analysed for efficacy) M 70, F 14 Mean age 25 years Baseline pain moderate to severe Exclusions: 1 participant in placebo group lost to follow‐up, 15 protocol violations |
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Interventions | Felbinac gel 3%, 3 x 1 cm daily, n = 41 Placebo gel, n = 43 Ice, joint immobilisation, bandaging and compression allowed No concomitant oral NSAID, occlusive dressing, physiotherapy, or liniments allowed Rescue medication: paracetamol |
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Outcomes | PGE: 5‐point scale (responder = "good" and "very good") Change in PI: patient diary 10 cm VAS (mean data) Adverse events Withdrawals and exclusions |
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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) | Low risk | "Randomisation was undertaken at the production facility and a sealed copy of the list supplied to the investigator for reference, only in defined circumstances" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical tubes and outer boxes", "placebo was a similarly constituted gel" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All relevant participants included in analysis |
Size | High risk | < 50 participants per treatment arm |