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. 2016 Oct 13;2016(10):CD006380. doi: 10.1002/14651858.CD006380.pub3

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
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
  1. gabapentin titrated in increments of 300 mg up to 2400 mg or maximal tolerable dose for 6 weeks; oral

  2. placebo

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
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