Abstract
Background The aim of the present study was to evaluate the effects of electroacupuncture (EA) in hemodialysis patients with restless leg syndrome (RLS) by heart rate variability (HRV) monitor. Methods112 subjects who were hemodialysis patients with RLS will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 2 times a week for 4 weeks. After 4 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include HRV recordings, International Restless Legs Syndrome Rating Scale (IRLSRS) and Insomnia Severity Index (ISI). DiscussionThis study is the first investigation to analyze the relationship between EA and the change of HRV by an objective monitor. If the findings of the current trial are positive, this study will also help support an effective, safe and cheap approach to clinical treatment of this challenging disorder, help foster improved understanding the relationship between RLS and HRV, and ultimately contribute to elucidate the mechanisms of EA. Trial registrationClinicalTrials.gov Identifier: NCT04356794; registration date: April 22, 2020.
The effect of electroacupuncture on hemodialysis patients with restless legs syndrome (RLS): study protocol for a randomized crossover trial