DRKS00029960已完成未知
Hydrotherapy and acupressure in restless legs syndrome – a randomized, controlled, three-armed, explorative clinical trial - HYDRAC
Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie0 个研究点目标入组 54 人开始时间: 2022年8月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.).
研究者
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