Methods | RCT, DB, parallel groups Gel massaged into skin over affected heel three times daily after cleaning with soap and water for up to 21 days Assessment at baseline, 7, 21 days |
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Participants | Acute achilles heel tendinitis (not associated with continuous pain at rest or >1 month history) N = 243 (227 analysed for efficacy) M/F not reported Mean age 29 years Baseline pain: ~10% had <26 mm on palpation of tendon, ~30% had mild or no pain on dorsifexion of foot Exclusions: failure to meet inclusion criteria, major protocol violations, failure to take study medication for full duration |
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Interventions | Niflumic acid gel 2.5%, 3× 5 g daily, n = 117 Placebo gel, n = 110 No other analgesics and antiinflammatories, physiotherapy or supportive measures allowed |
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Outcomes | PGE: 5 point scale (responder = “good” or “very good”) Pain improved or disappeared on dorsiflexion Adverse events Withdrawals and exclusions |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3/5 Oxford Validity Score: 12/16 |
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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 |
Unclear risk | Not described |