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. 2014 Apr 27;2014(4):CD007938. doi: 10.1002/14651858.CD007938.pub3
Methods Randomised, double‐blind, placebo‐controlled, parallel‐group, not enriched. Both LOCF and BOCF imputation methods used in analyses
Itrathecal drug delivery system implanted and filled with saline until randomisation. Fixed dose of gabapentin (1 mg, 6 mg or 30 mg/d) or placebo for 22 days, followed by 7‐day taper
Participants Chronic intractable pain below neck for ≥ 1 year (86% classified as neuropathic or mixed). N = 170, mean age 50 years, 58% women. PI at randomisation 7.5/10, initial average daily pain ≥ 5/10
Interventions Gabapentin injection 1 mg, 6 mg, 30 mg daily, n = 42, 41, 43 respectively
Placebo (saline) injection, n = 44
Outcomes Pain intensity reduction
Adverse events
Withdrawals
Notes Oxford Quality Score: R = 1, DB = 2, W = 1, Total = 4
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Low risk "coded drug syringe labels, stored in sealed, sequentially numbered randomization envelopes". Pharmacist took next sequential envelope, prepared assigned drug, and attached coded label before sending to clinic
Blinding (performance bias and detection bias) All outcomes Low risk Both treatments were clear liquids. Saline (placebo) "seemed identical to gabapentin"
Incomplete outcome data (attrition bias) Efficacy Low risk BOCF analysis reported alongside LOCF
Size Efficacy High risk < 50 participants per treatment group
Study duration Efficacy High risk 22 days
Outcomes reported Unclear risk ≥ 30% reduction in pain