Figure 2. Comparative Outcomes Assessment for the Primary Outcome.

Oswestry Disability Index scores range from 0 points (no disability) to 100 points (maximum disability). Scores greater than 40 indicate severe disability. The minimal clinically important difference was 10 points. Each bar extends from a patient’s baseline score to their mean score at the end of the treatment allocation periods. Among the 50 patients who were randomized, 2 patients allocated to burst stimulation and 1 allocated to placebo stimulation did not have follow-up scores starting at 3 months. Among the 47 patients who underwent randomization and had at least 1 follow-up score, there were 91 burst stimulation periods and 89 placebo stimulation periods. Of these 180 treatment periods, follow-up scores were available for 178. The mean score at baseline was 44.7 points and the mean score changes were −10.6 points (95% CI, −14.1 to −7.2 points) for burst stimulation and −9.3 points (95% CI, −12.7 to −5.9 points) for placebo stimulation. For patients with 2 placebo stimulation or burst stimulation follow-up periods, the outcomes are presented as the mean of the 2 burst stimulation periods and the mean of the 2 placebo stimulation periods.