G25.81
Conditions
Interventions
Group 1: kneipp hydrotherapy, duration 6 to 12 weeks
Group 2: acupressure, duration 6 to 12 weeks
Group 3: waiting list
Sponsors
Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. age between 18 years and 70 years 2. presence of a diagnosis of idiopathic RLS confirmed by a specialist. 3. subjective intensity of RLS symptoms greater than or equal to 30 on a visual analogue scale of 0-100 mm in the last 7 days before inclusion. 4. no planned change in medication during the study period. 5. at least moderate RLS symptoms (IRLS - total score = 11 on a severity scale validated by the International Restless Legs Syndrome Study Group (IRLS)). 6. willingness of the patient to be randomised and to take part in the examinations within the framework of the study or to complete questionnaires/diaries. 7. the patient is capable of giving consent and is cognitively and linguistically able to understand the significance of the study. 8. signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. known secondary restless legs syndrome 2. regular use of medications that cause restless legs syndrome 3. use of hydrotherapy, acupuncture or acupressure in the last 4 weeks before inclusion or planned in the next 12 weeks. 4. acute infection with the SARS-COV-2 virus or presence of a long-COVID syndrome as well as positive SARS-COV-2 test according to the currently valid regulations of the Charité. 5. for women: Pregnancy or breastfeeding. 6. presence of a serious acute and/or chronic organic or serious mental illness that does not allow participation in the study intervention. 7. medication, drug and/or alcohol abuse. 8. treatment with opioids. 9. participation in an intervention study during the same period of the study or in the last 3 months before the start of the study for this condition. 10. advanced cardio/pulmonary disease (NYHA/GOLD III+IV). 11. dependence on the study centre (e.g. employed). 12. known Raynaud's disease and advanced circulatory disorders of the extremities. 13. known cold agglutinin disease. 14. inadequately treated dermatological disease in the treatment area (large wounds, severe neurodermatitis, severe psoriasis, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| at baseline and after 6 and 12 weeks: - Severity of RLS according to the IRLSSG Rating Scale (IRLSSG-RS). - disease-related quality of life using the RLS-Qol questionnaire - Health-related quality of life Short-Form 12 (SF-12) questionnaire - Hospital Anxiety and Depression Scale (HADS-D) - Self-efficacy (SWE) questionnaire - Subjective general well-being on a Visual Analogue Scale (VAS, minimum 0 to maximum 100 mm). - Change in general condition PGI-C (Patient Global Impressions scale - Change) - Assessment of change in daily activities furthermore: - Expectations and assessment of effectiveness of the intervention at baseline - Evaluation of the therapy success and assessment of the general effectiveness of the interventions after 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| this is an exploratory study without differentiation into a primary and secondary outcome | — |
Countries
Germany
Contacts
Public ContactJulia Siewert
Charité - Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Projektbereich Komplementäre und Integrative Medizin
Outcome results
None listed