Cohen 2015.
Methods | Multicentre, randomised, double‐blind (double‐dummy), active‐controlled, parallel groups, partial enrichment. Titration to maximum tolerated dose (1800 mg to 3600 mg daily) over 15‐24 days (3 months total) | |
Participants | Radicular leg pain for ≥ 6 weeks and < 4 years, PI ≥ 4/10 or ≥ 3/10 if leg pain ≥ back pain, symptoms of lumbosacral radicular pain. Findings of herniated disc or spinal stenosis on MRI concordant with presentation. Age ≥ 17 years
Excluded: neuropathic pain > 4 years, previous failed trial with gabapentin or pregabalin, steroid injections ≤ 3 years, cauda equina syndrome, planned surgery N = 145 Mean age 43 years, 26% women 18% had pain ≤ 3 months, 25% taking opioids Initial PI: worst leg 7.8/10; average leg 5.4/10 |
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Interventions | Gabapentin capsule + saline injection, n = 72 Depomethylprednisolone 60 mg injection + 1 ml 0.25% bupivacaine + placebo capsule, n = 73 Gabapentin titrated to 1800 mg to 3600 mg/day (3 divided doses) over 15‐24 days, but ≥ 5 days before follow‐up Steroid injected into epidural space (interlaminar or transforaminal), saline injected into posterior ligaments Tramadol and NSAIDs "as needed" for rescue medication, or opioids increased by ≥ 20% for those taking them. No other co‐interventions |
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Outcomes | Mean PI, for average and worst leg and back pain Global evaluation (non‐standard scales) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 Congressional grant from the Center for Rehabilitation Sciences Research, Bethesda |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation tables, stratified by site. Central pharmacy |
Allocation concealment (selection bias) | Low risk | "sequentially numbered opaque sealed envelope" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "A central research pharmacy over‐capsulated 300 mg gabapentin and placebo capsules to appear identical". Participants "visually shielded from the image screen" during injections", had no further contact with physician |
Incomplete outcome data (attrition bias) Efficacy | Unclear risk | LOCF imputation |
Size Efficacy | Unclear risk | 50‐200 participants per treatment arm |