Kubasch Julia, Ortiz Miriam, Binting Sylvia, Roll Stephanie, Icke Katja, Dietzel Joanna, Nögel Rainer, Hummelsberger Josef, Willich Stefan N, Brinkhaus Benno, Teut Michael, Siewert Julia
Charité - Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.
International Society for Chinese Medicine (SMS), Munich, Germany.
Front Med (Lausanne). 2025 Apr 16;12:1571045. doi: 10.3389/fmed.2025.1571045. eCollection 2025.
STUDY 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), 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. RESULTS: Fifty-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. 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. CLINICAL TRIAL REGISTRATION: This study was registered in the German Clinical Trials Register (number DRKS00029960) on August 09, 2022. https://drks.de/search/de/trial/DRKS00029960.
研究目的:不安腿综合征(RLS)的非药物干预措施虽常被使用,但科学证据仍然有限。本研究旨在调查自我实施水疗法和自我实施指压疗法对RLS患者的可行性及效果。 方法:在一项三臂随机单中心开放性探索性初步研究中,将中度至重度RLS的成年人随机分配至接受为期6周的每日水疗法加常规护理(HT组)、指压疗法加常规护理(AP组)或仅接受常规护理(RC组)。结局指标包括RLS症状严重程度(国际不安腿综合征评定量表,IRLS)、疾病特异性生活质量(RLS生活质量量表,RLSQoL)、变化印象(医师整体评估量表,PGI-C)、健康相关生活质量(简明健康调查量表,SF-12)、心理结局(症状自评量表,SGW-B;医院焦虑抑郁量表,HADS;一般自我效能感量表,GSE)以及6周和12周后的依从性和不良事件(AE)。 结果:纳入了54名成年人(平均年龄57.5±11.4岁,63%为女性)。该研究显示出良好的可行性,保留率为83%。6周后,经基线调整的平均IRLS评分,HT组为19.8(95%[16.4, 23.2]),AP组为22.9(19.2, 26.6),RC组为24.0(20.8, 27.2)。6周后,RLSQoL调整后的均值,HT组为65.3(59.7, 70.9),AP组为68.3(62.3, 74.3),RC组为56.2(50.9, 61.5)。两种干预措施均安全,依从率高。 结论:自我实施水疗法和指压疗法对RLS患者似乎是可行且安全的干预措施。这项探索性初步研究表明了潜在益处,不过需要更大规模、设计良好的验证性研究来证实这些发现。 临床试验注册:本研究于2022年8月9日在德国临床试验注册中心注册(编号DRKS00029960)。https://drks.de/search/de/trial/DRKS00029960 。
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