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

Wu 2012.

Study characteristics
Methods Randomised, DB, pilot, parallel sequence; 1 group receiving BoNT/A injections and another group receiving combination lidocaine and methylprednisolone injections; “one physician was chosen to implement the treatment protocol for all patients after randomisation.”
Ff‐up at 1, 2, 3 ,4 ,5,6 mos
Participants Adult lower extremity amputees with PLP or RLP, or both with VAS > 5/10 and unresponsive to conventional treatment
Interventions
  1. Injections of BoNT/A with dosage of 1 mL equal to 50 units of BoNT/A into painful sites; 1 treatment episode

  2. Injections of 1 mL mixture of 0.75 mL of 1% lidocaine and 0.25 mL of lidocaine/methylprednisolone 40 mg/mL into painful sites; 1 treatment episode

Outcomes Pain intensity by 0‐to‐10 VAS;
Changes in pressure pain tolerance;
Dropouts/withdrawals
Notes Study has a small size; n = 14
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Technique of allocation not clearly described
Blinding (performance bias and detection bias)
All outcomes Low risk Participants were blinded to the type of treatment they received; medications same in appearance, dosage amount, and route
Blinding of outcome assessment (detection bias)
All outcomes Low risk Evaluators were blinded to the type of treatment participants received
Incomplete outcome data (attrition bias)
All outcomes Unclear risk The study described the dropouts and withdrawals during the course of the study, but unclear whether these were included in the 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 Unclear risk Uncertain if baseline characteristics similar in both groups
Size of study High risk n = 14 (but only an initial report)

BI: Barthel Index; BoNT/A: botulinum toxin A; CES‐D: Center for Epidemiologic Studies Depression Scale; CHART: Craig Handicap Assessment and Reporting Technique; CI: confidence interval; DB: double‐blind; FIM: Functional Independence Measure; ff‐up: follow‐up; HADS: Hospital Anxiety and Depression Scale; ICF: intracortical facilitation; ICI: intracortical inhibition; IU: international unit; IV: intravenous; max: maximum; mos: months; MPQ: McGill Pain Questionnaire; n: number of participants; NNTB: number needed to treat for an additional beneficial outcome; NAS: numerical analogue scale; NRS: numerical rating scale; PDI: Pain Disability Index; PLP: phantom limb pain; RLP: residual limb pain; QOL: quality of life; SD: standard deviation; SF‐MPQ: Short‐Form McGill Pain Questionnaire; SIS: Sleep Interference Scale; TMS: transcranial magnetic stimulation; VAS: visual analogue scale; wks: weeks; yrs: years.