Methods | Randomised, double-blind, placebo-controlled, cross-over, not enriched. No imputation method mentioned Titration to limit of tolerability or maximum of 3600 mg over 4 weeks, then stable dose for remainder of 8-week period; 2-week washout then cross-over |
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Participants | Complete traumatic SCI at lumbar or thoracic level. N = 20, mean age 36 years, 35% women. Pain duration before treatment ≥ 6 months, PI at randomisation > 4/10, initial average daily pain 9/10 | |
Interventions | Gabapentin 3600 mg daily (max) Placebo Mean max tolerated dose of gabapentin 2850 ± 751 mg No concurrent analgesics allowed |
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Outcomes | Pain reduction (mean data only) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1, Total = 4 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | Not reported |
Blinding? All outcomes |
Yes | “identically appearing capsules” |
Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
Size Efficacy |
No | 20 randomised |
Study duration Efficacy |
Yes | 8-week period |
Outcomes reported | No | No dichotomous data |