Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)

Study objectivesNon-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.MethodsIn a...

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Main Authors: Julia Kubasch, Miriam Ortiz, Sylvia Binting, Stephanie Roll, Katja Icke, Joanna Dietzel, Rainer Nögel, Josef Hummelsberger, Stefan N. Willich, Benno Brinkhaus, Michael Teut, Julia Siewert
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1571045/full
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author Julia Kubasch
Miriam Ortiz
Sylvia Binting
Stephanie Roll
Katja Icke
Joanna Dietzel
Rainer Nögel
Josef Hummelsberger
Stefan N. Willich
Benno Brinkhaus
Michael Teut
Julia Siewert
author_facet Julia Kubasch
Miriam Ortiz
Sylvia Binting
Stephanie Roll
Katja Icke
Joanna Dietzel
Rainer Nögel
Josef Hummelsberger
Stefan N. Willich
Benno Brinkhaus
Michael Teut
Julia Siewert
author_sort Julia Kubasch
collection DOAJ
description Study objectivesNon-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.MethodsIn 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), the impression of change (PGI-C), health-related quality of life (SF-12), psychological outcomes (SGW-B, HADS, and GSE), and adherence and adverse events (AEs) after 6 and 12 weeks.ResultsFifty-four adults (mean age 57.5 ± 11.4 years, 63% women) were included. The study showed good feasibility with an 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.ConclusionSelf-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.Clinical trial registrationThis study was registered in the German Clinical Trials Register (number DRKS00029960) on August 09, 2022. https://drks.de/search/de/trial/DRKS00029960.
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spelling doaj-art-7c65020da4ce41b4a3b72ed2bd7b73b92025-08-20T02:26:24ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-04-011210.3389/fmed.2025.15710451571045Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)Julia Kubasch0Miriam Ortiz1Sylvia Binting2Stephanie Roll3Katja Icke4Joanna Dietzel5Rainer Nögel6Josef Hummelsberger7Stefan N. Willich8Benno Brinkhaus9Michael Teut10Julia Siewert11Charité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyInternational Society for Chinese Medicine (SMS), Munich, GermanyInternational Society for Chinese Medicine (SMS), Munich, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyCharité – Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, GermanyStudy objectivesNon-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.MethodsIn 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), the impression of change (PGI-C), health-related quality of life (SF-12), psychological outcomes (SGW-B, HADS, and GSE), and adherence and adverse events (AEs) after 6 and 12 weeks.ResultsFifty-four adults (mean age 57.5 ± 11.4 years, 63% women) were included. The study showed good feasibility with an 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.ConclusionSelf-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.Clinical trial registrationThis study was registered in the German Clinical Trials Register (number DRKS00029960) on August 09, 2022. https://drks.de/search/de/trial/DRKS00029960.https://www.frontiersin.org/articles/10.3389/fmed.2025.1571045/fullrestless legs syndromecomplementary and integrative medicinehydrotherapyKneipp therapyacupressurerandomized controlled trial
spellingShingle Julia Kubasch
Miriam Ortiz
Sylvia Binting
Stephanie Roll
Katja Icke
Joanna Dietzel
Rainer Nögel
Josef Hummelsberger
Stefan N. Willich
Benno Brinkhaus
Michael Teut
Julia Siewert
Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
Frontiers in Medicine
restless legs syndrome
complementary and integrative medicine
hydrotherapy
Kneipp therapy
acupressure
randomized controlled trial
title Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
title_full Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
title_fullStr Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
title_full_unstemmed Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
title_short Hydrotherapy and acupressure in restless legs syndrome: results of a randomized, controlled, three-armed, pilot study (HYDRAC-study)
title_sort hydrotherapy and acupressure in restless legs syndrome results of a randomized controlled three armed pilot study hydrac study
topic restless legs syndrome
complementary and integrative medicine
hydrotherapy
Kneipp therapy
acupressure
randomized controlled trial
url https://www.frontiersin.org/articles/10.3389/fmed.2025.1571045/full
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