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CLINICAL TRIAL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1571045
This article is part of the Research Topic The Increasing Relevance of Traditional Medicine Systems for the Primary Health Care Sector and General Practice: Global Research Perspectives – Volume II View all 10 articles
Hydrotherapy and acupressure in restless legs syndrome -results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
Provisionally accepted
Julia Kubasch 1*
Miriam Ortiz 1
Sylvia Binting 1 Stephanie Roll 1 Katja Icke 1
Joanna Dietzel 1 Rainer Noegel 2
Josef Hummelsberger 1
Stefan Willich 1 Benno Brinkhaus 1 Michael Teut 1 Julia Siewert 1*- 1 Institute of Social Medicine, Epidemiology and Health Economics, Charité University Medicine Berlin, Berlin, Germany
- 2 International Society for Chinese Medicine, Munich, Bavaria, Germany
AbstractStudy Objectives: Non-pharmacological interventions for Restless Legs Syndrome (RLS) are frequently used, although scientific evidence remains limited. The study aimed to investigate the feasibility and effects of self-applied hydrotherapy and self-applied acupressure in patients with RLS.Methods: In a three-armed randomized single center open exploratory pilot study, adults with moderate to severe RLS were randomly allocated to 6 weeks of daily hydrotherapy plus routine care (HT group), acupressure plus routine care (AP group), or routine care alone (RC group). Outcome measures included RLS symptom severity (IRLS), disease specific quality of life (RLSQoL), impression of change (PGI-C), health related quality of life (SF-12, psychological outcomes (SGW-B, HADS, GSE), adherence and adverse events (AEs) after 6 and 12 weeks. Results: Fifty-four adults (mean age 57.5 ± 11.4 years, 63% women) were included. The study showed good feasibility with 83% retention rate. After 6 weeks, baseline-adjusted mean IRLS scores were 19.8 (95% [16.4, 23.2]) for HT, 22.9 (19.2, 26.6) for AP, and 24.0 (20.8, 27.2) for RC. RLSQoL adjusted means were 65.3 (59.7, 70.9) for HT, 68.3 (62.3, 74.3) for AP and 56.2 (50.9, 61.5) for RC, after 6 weeks. Both interventions were safe, with high adherence rates.Conclusion: Self-applied hydrotherapy and acupressure appear to be feasible and safe interventions for patients with RLS. This exploratory pilot study suggests potential benefits, though larger, well-designed confirmatory studies are needed to validate these findings.
Keywords: Restless Legs Syndrome, complementary and integrabve medicine, Hydrotherapy, Kneipp therapy, Acupressure, randomized controlled trial
Received: 04 Feb 2025; Accepted: 14 Mar 2025.
Copyright: © 2025 Kubasch, Ortiz, Binting, Roll, Icke, Dietzel, Noegel, Hummelsberger, Willich, Brinkhaus, Teut and Siewert. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Julia Kubasch, Institute of Social Medicine, Epidemiology and Health Economics, Charité University Medicine Berlin, Berlin, Germany
Julia Siewert, Institute of Social Medicine, Epidemiology and Health Economics, Charité University Medicine Berlin, Berlin, Germany
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