Hydrotherapy and acupressure in restless legs syndrome – a randomized, controlled, three-armed, explorative clinical trial
- Conditions
- G25.81
- Registration Number
- DRKS00029960
- Lead Sponsor
- Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
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.
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.).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method at baseline and after 6 and 12 weeks:<br>- Severity of RLS according to the IRLSSG Rating Scale (IRLSSG-RS). <br>- disease-related quality of life using the RLS-Qol questionnaire<br>- Health-related quality of life Short-Form 12 (SF-12) questionnaire <br>- Hospital Anxiety and Depression Scale (HADS-D)<br>- Self-efficacy (SWE) questionnaire<br>- Subjective general well-being on a Visual Analogue Scale (VAS, minimum 0 to maximum 100 mm). <br>- Change in general condition PGI-C (Patient Global Impressions scale - Change)<br>- Assessment of change in daily activities<br>furthermore:<br>- Expectations and assessment of effectiveness of the intervention at baseline<br>- Evaluation of the therapy success and assessment of the general effectiveness of the interventions after 6 and 12 weeks<br>
- Secondary Outcome Measures
Name Time Method this is an exploratory study without differentiation into a primary and secondary outcome