Bone 2002.
Study characteristics | ||
Methods | Randomised, DB, cross‐over; 6 weeks each treatment arm; 1 week wash‐out period; computer‐generated randomisation Ff‐up at 6 wks |
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Participants | Phantom pain of at least 6 months with pain intensity of at least 40 mm on 100‐millimetre VAS scale; majority with lower limb amputations; time since amputation is 18 months; 19 participants, 15 males; mean age, yrs (SD): 56.25 (17.5); baseline mean pain intensity (SD) (converted and presented in cm VAS by Bone 2002 study authors): treatment group 6.1 (1.8); placebo 6.7 (1.9) | |
Interventions |
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Outcomes | Change in pain intensity 100‐millimetre VAS at end of treatment week 6 vs baseline (converted and presented in cm VAS by Bone 2002 study authors); Mean pain intensity difference at end of treatment week 6; Categorical phantom pain intensity (0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain) end of treatment to baseline; Change in mood on HADS; Change in function on BI; Change in sleep on SIS; Number of rescue tablets; Adverse events; Dropouts/withdrawals |
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Notes | For lifestyle indices, sample size may be too small to rule out type 2 error; used between‐group analysis for comparisons; n = 19 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Organized remotely (hospital pharmacist) |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical coded medication bottles containing identical tablets of gabapentin and placebo" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described who assessed and if blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Data from these 19 patients were included in the results presented, using intention‐to‐treat analysis" |
Selective reporting (reporting bias) | Low risk | All specified outcomes in methods section of published study were reported, although not necessarily as our preferred outcomes |
Other bias | Low risk | (+) wash‐out period; baseline VAS pain score before placebo/gabapentin not significantly different |
Size of study | High risk | n = 19 |