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 |
|
|
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.