Auclair 1989.
Methods | R, DB, PC, parallel groups Gel massaged into skin over affected heel 3 times daily after cleaning with soap and water for up to 21 days Assessment at baseline, 7, 21 days |
|
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 dorsiflexion of foot Exclusions: failure to meet inclusion criteria, major protocol violations, failure to take study medication for full duration |
|
Interventions | Niflumic acid gel 2.5%, 3 x 5 g daily, n = 117 Placebo gel, n = 110 No other analgesics and anti‐inflammatories, physiotherapy or supportive measures allowed |
|
Outcomes | PGE: 5‐point scale (responder = "good" or "very good") Pain improved or disappeared on dorsiflexion Adverse events Withdrawals and exclusions |
|
Notes | Oxford Quality Score: R1, DB1, W1. Total = 3/5 | |
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 | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10% excluded for "failing to meet entry criteria and protocol violations". No further details |
Size | Unclear risk | 50 to 200 participants per treatment group |