Ăkermark 1990.
Methods | R, DB (double dummy), PC, AC, parallel groups Spray applied to affected area, and capsules taken 3 times daily for 2 weeks Assessment at baseline, 3 or 4, 7, and 14 days |
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Participants | Superficial overuse sports injuries (symptom onset 7.4 weeks) N = 70 M 44, F 18 (completers) Mean age 30 years Baseline pain on palpation mostly slight to moderate |
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Interventions | Elmetacin spray (indomethacin 1%), 3 to 5 x 0.5 to 1.5 ml daily + placebo capsules, n = 23 Indomethacin capsules, 3 x 25 mg daily + placebo spray, n = 23 Placebo spray and capsules, n = 24 Rescue medication: paracetamol |
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Outcomes | No pain on palpation (= responder) Participant improvement: 100 mm VAS (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "random number code" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical in appearance" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Responder analysis, < 5% withdrawals |
Size | High risk | < 50 participants per treatment group |
AC: active control; BOCF: baseline observation carried forward; DB: double‐blind; DHEP: diclofenac hydroxyethylpyrrolidine, or diclofenac epolamine; F: female; HCl: hydrochloride; hep: heparin; LOCF: last observation carried forward; M: male; N: number of participants in study; n: number of participants in treatment arm; PC: placebo control; PGE: Participant Global Evaluation; PI: pain intensity; R: randomised; VAS: visual analogue scale; W: withdrawals.