Study design
micro-lesions
A prospective, randomized, double-blind, cross-over study design was applied with two 2-month treatment periods subsequent to a 2-month postoperative period (see Randomized double-blind cross-over study design. The patients were brought in for baseline evaluations preoperatively. The operation was followed by a two-month familiarization phase with stimulation OFF, and to account for possible micro-lesions effects. At two months postoperatively, the patients visited for a postoperative evaluation, randomization of stimulation settings, and titration of the stimulation settings. At four months postoperatively, the patients visited again for the first treatment evaluation, cross-over, and stimulation titration. The second treatment evaluation, marking the end of the study, was performed at six months postoperatively.