Random allocation aims to make prognostic factors similar on average between groups before the intervention begins, reducing confounding in the estimated comparison.
A control group may receive sham stimulation, another intervention, standard care, or no intervention. Blinding, allocation concealment, adherence, missing data, outcome measurement, and selective reporting still affect validity.
An RCT estimates an effect for the tested population, protocol, comparator, and outcomes. Its result should not automatically be transferred to another device, dose, setting, or intended use.