Participants
nausea, diarrhea, epilepsy, peripheral neuropathy, allergy, anemia, RLS, primary sleep disorders
EPILEPSY, ALLERGY, ANEMIA, SKIN CONDITION, PERIPHERAL NEUROPATHY
This study recruited adults aged 18–89 years with primary RLS taking prescription opioids for refractory RLS. Participants were required to maintain a stable dose of all RLS medications for the 30 days prior to study entry and a stable dose of non-opioid RLS medications throughout the study. Key inclusion criteria were baseline opioid dose ≤ 60 morphine milligram equivalents (MMEs) per day with RLS symptoms most significant in lower extremities. The MME dose limit was intended to reduce the impact of opioid withdrawal symptoms unrelated to RLS (e.g., nausea, diarrhea). Key exclusion criteria were inadequately treated primary sleep disorders other than RLS, prior experience with the study device, unstable doses of sleep medications or antidepressants, severe peripheral neuropathy affecting the lower legs, skin conditions affecting the application site, severe RLS symptoms between 10 am and 6 pm, known allergy to device materials, active medical device implants, epilepsy, dialysis, and iron-deficient anemia. All participants were from the investigators’ clinical practices except for two participants recruited from online advertisements. As prespecified in the protocol, a pilot phase consisting of 1 participant was conducted prior to the primary study and data from the pilot phase were not included in the analysis.