| 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 |