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Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain

By Kirstin Ahmed

To promote transparency and proper adherence to the scientific method, we published a protocol for the statistics we planned to conduct for our international clincial trial investigating purposeful control over the phantom limb as a treatment for phantom limb pain. The primary outcome of the study is to examine whether 15 sessions of out treatment can induce greater phantom limb pain relief, compared to a placebo treatment. The statistical analysis plan was written and published prior to reviewing the completed dataset to reduce bias when reporting the overall study results. The degree of phantom limb pain relief, in addition to other study outcomes to be examined, will provide insight into the mechanism behind phantom limb pain and its treatments, which serves to guide future developments of phantom limb pain treatments.