Bischoff 2014.
Study characteristics | ||
Methods | RCT, DB, PC, parallel group, single application, 12‐week duration. Pain assessment twice daily in 3 days before treatment and clinical visits at 1, 2, 3 months. |
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Participants | Persistent pain after inguinal herniorrhaphy score ≥ 5/10 for > 6 months Exclusion: bilateral groin pain, allergy to any component of treatment, comorbidity that might interfere with treatment or assessment N = 46 M = 42, F = 4 Mean age: 54 years Baseline pain on movement: 5.5/10 (range 3 to 7) |
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Interventions | (1) Capsaicin patch 8%, n = 24 (23 treated) (2) Placebo patch, n = 22 Topical local anaesthetic (EMLA; lidocaine + prilocaine) applied for 60 min, then patch applied to groin area for 60 min Cool packs applied to skin for 45 to 60 min after patch removal and cleansing Stable (≥ 4 weeks) analgesic medication continued without change |
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Outcomes | SPID ‐ difference between groups at 4, 8, 12 weeks AEs Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 Study terminated early due to expiry of placebo patch |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated randomization list" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "placebo patches were identical in appearance and composition (in regard to vehicle substances)". 70% of capsaicin participants and 80% of placebo participants correctly guessed assignment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Imputation unclear |
Size | High risk | < 50 participants per treatment arm |