Table 3.
Efficacy results.
| Endpoint | NPNS | Sham | P |
|---|---|---|---|
| IRLS | .003* | ||
| Baseline, SD | 24.0 | 24.0 | |
| During treatment, SD | 17.2 | 20.6 | |
| Mean change (SEM) | –6.81 (0.94) | –3.38 (0.96) | |
| CGI-I | |||
| Responder rate | 66% | 17% | .001* |
| Daily NRS | |||
| Before | 4.25 | 4.39 | |
| During (% change) | 3.43 (–19.5%) | 3.92 (–10.9%) | .010* |
| After (% change) | 2.96 (–52.5%) | 4.47 (+1.9%) | .003* |
| Summary NRS | |||
| Before | 3.59 | 3.47 | |
| During (% change) | 2.50 (–30.3%) | 2.85 (–17.8%) | .088 |
| After (% change) | 1.91 (–46.7%) | 3.35 (–3.4%) | .002* |
P values denote comparisons between NPNS and sham and (*) denotes statistical significance at P < .05; 2-tailed matched-pairs t tests were used for IRLS, Daily NRS, and Summary NRS and a continuity-corrected paired proportions McNemar’s test was used for CGI-I. Values compared with statistical tests are in bold. Mean change in IRLS during NPNS and sham is relative to baseline (study entry) and % change to Daily and Summary NRS is relative to the “Before” time-point. CGI-I = Clinical Global Impressions-Improvement, IRLS = International RLS Study Group rating scale, NPNS = noninvasive peripheral nerve stimulation, NRS = Numerical Rating Scale, SD = standard deviation, SEM = standard error of the mean.