Table 2.
Summary of adverse events.
| NPNS (n = 43) | Sham (n = 43) | P | |
|---|---|---|---|
| All | 11 (25.6) | 6 (14.0) | .18 |
| Device-related | 10 (23.3) | 6 (14.0) | .27 |
| Transient increase in RLS symptomsa | 5 (11.6) | 2 (4.7) | .24 |
| Uncomfortable sensations during stimulationa | 5 (11.6) | 0 (0.0) | .02* |
| Skin irritationa | 1 (2.3) | 4 (9.3) | .17 |
| Muscle fatigue | 1 (2.3) | 0 (0.0) | .31 |
| Upper respiratory infection | 1 (2.3) | 0 (0.0) | .31 |
| Gastrointestinal distress | 1 (2.3) | 0 (0.0) | .31 |
| Flu | 1 (2.3) | 0 (0.0) | .31 |
Incidence of each adverse event (AE) category shown in terms of number (n) and percentage (in parentheses) of participants during NPNS and sham, where (a) denotes device-related AE category. P values denote comparisons between NPNS and sham and (*) denotes statistical significance at P < .05 on a continuity-corrected paired proportions McNemar’s test. NPNS = noninvasive peripheral nerve stimulation, RLS = restless legs syndrome.