Rintala 2007.
Methods | Randomised, double‐blind, placebo‐controlled, 3‐way cross‐over, not enriched. No imputation method mentioned Titration over 4 weeks to pain control, limit of tolerability, or maximum amitriptyline 150 mg daily, gabapentin 3600 mg daily, then stable dose for remainder of 8‐week period; 1‐week washout then cross‐over Analysis for completers only |
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Participants | SCI at any level and degree of completeness. Pain duration before treatment > 6 months, PI at randomisation > 5/10 N = 38, only 22 participants completed all 3 cross‐overs Mean age 43 years, 9% women Initial pain intensity 5.6/10 |
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Interventions | Amitriptyline 150 mg daily (max) Gabapentin 3600 mg daily (max) Placebo (diphenhydramine) 75 mg daily Oxycodone + paracetamol 5/325 mg (max 8 tablets daily) allowed for rescue medication |
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Outcomes | No dichotomous data for efficacy or harm Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 Department of Veterans Affairs grant |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "table of random numbers" |
Allocation concealment (selection bias) | Low risk | Prepared, packaged and labelled by remote, commercial compounding pharmacy |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical capsules" |
Incomplete outcome data (attrition bias) Efficacy | High risk | Completers only |
Size Efficacy | High risk | < 50 participants per treatment arm (38 randomised, 22 completed 3 phases) |