3. Discussion
Restless Legs Syndrome, RLS/WED, anxiety, RLS-severity, RLS, depression
RECRUITMENT, RESTLESS LEGS SYNDROME
The present exploratory RCT will be the first to investigate whether there is evidence for the effects of self-applied Kneipp hydrotherapy and acupressure in patients with RLS and whether it is reasonable to conduct a subsequent confirmatory study in a larger patient population.Our requirement is that the inclusion and exclusion criteria be comparable to those of other high-quality studies on RLS. Thus, the study inclusion and exclusion criteria were based on the RLS/WED diagnostic criteria according to the updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria of 2014.We want to investigate not only a non-drug approach but also an intervention that can be performed independently by the patient. Self-applicable therapies empower patients, but rely on motivation. To promote motivation and adherence to the intervention, we use diaries and contact patients by telephone 1 and 3 weeks after randomization. Problems regarding implementation and the need for further training will be ascertained through telephone interviews. This also allows for immediate optimization of the intervention and (if necessary) improves the implementation of the intervention and the intervention itself in a future full-scale study.All patients in the intervention groups also receive a handout with the corresponding intervention instructions in the text and pictures at the beginning of the study.This study uses a well-defined acupressure protocol that focuses on 6 specific acupuncture points, some of which have already been shown to be effective in previous acupuncture and acupressure studies in RLSKneipp hydrotherapy was chosen because it is a well-known and recognized treatment concept in Germany that can be carried out independently at home without additional equipment and without much time expenditure, and has shown good acceptance in previous studies.A twice-daily application was chosen because a previous study on Kneipp hydrotherapy in patients with menopausal symptoms showedBy recruiting patients broadly, both online, in public transportation, and in physicians’ offices and through self-help groups, the study aims to find a representative group of patients in terms of socioeconomic status, age distribution, and comorbidities. This study uses valid, reliable, and internationally accepted assessment tools to measure changes in RLS-severity, including sleep quality, depression, anxiety, and QoL. If effects are detectable, the data obtained can help determine recruitment potential, subsequent sample size calculation, reasonable number and frequency of interventions, and further parameters needed to successfully design a subsequent full-scale study.