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. 2017 Jan 13;2017(1):CD007393. doi: 10.1002/14651858.CD007393.pub4

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.
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)
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
Outcomes SPID ‐ difference between groups at 4, 8, 12 weeks
AEs
Withdrawals
Notes Oxford Quality Score: R2, DB2, W1. Total = 5/5
Study terminated early due to expiry of placebo patch
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