DRKS00017381已完成4 期
Randomized, prospective, double-blind study to objectively demonstrate the performance and safety of the Rayocomp bioresonance device in patients with cervical spine disorder - R-HWS
Rayonex Biomedical GmbH0 个研究点目标入组 54 人开始时间: 2019年5月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Gender: male and female
- •2) Age: at least 18 years
- •3) At least moderate pain (= 5 on the VAS) in the cervical spine area
- •4) Neck disabilty index with at least medium restriction (score = 15)
- •5) Patients must be able to understand the patient information
- •6) Patients must be willing and able to meet the requirements of the study
- •7) Signed ICF
排除标准
- •1) Systemic or inflammatory musculoskeletal disease (e.g., muscular dystrophies, polymyositis)
- •2) Trauma with fractures and surgical treatment
- •3) Severe systemic disease with a life expectancy <6 months (e.g., advanced heart failure, malignancies)
- •4) Massive degenerative disease with marked restriction of motility (e.g., polyarthritis)
- •5) Pregnant or breastfeeding female patients without effective contraception
- •6) Patients who, due to mental illness, are unable to understand the study information, give their consent, or adhere to the study's guidelines
- •7) Patients who, in the opinion of the investigator, are not suitable for the study
- •8) Alcohol or drug abuse
- •9) patients incapable of giving consent
- •10) Persons who are in a dependency or employment relationship with the sponsor or investigator
- •11) Detained persons
- •12) Participation in another study
研究者
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