A prospective single-centre study to assess the effectiveness of Closed-Loop Spinal Cord Stimulation (CL-SCS) in the treatment of chronic pain associated with primary and secondary Raynaud's Phenomenon - Closed-Loop SCS for the treatment of chronic pain associated with Raynaud's Phenomenon

niversitätsklinikum Bonn0 个研究点目标入组 10 人开始时间: 2022年9月6日最近更新: 2024年8月19日

试验速览

暂无简介。

•Confirmed diagnosis of either primary or secondary RP
•- Able to provide informed consent to participate in the study in accordance with Section 20, paragraph 2 of the MPG
•- Deemed able to operate the system
•- Deemed a suitable surgical candidate for SCS implantation
•- 18 years or older
•- Not pregnant or nursing
•- Not allergic, or have shown hypersensitivity, to any of the materials of the neurostimulation system which come in contact with the body
•- Average baseline frequency of =>2 Raynaud's attacks per week and/or an average severity of =>5

•- BMI =>35
•- Poorly adjusted arterial hypertension (at rest >170/100 mmHG)
•- Unstable coronary heart disease
•- Acute myocardial infarction within the last twelve weeks
•- Acute infection of trophic skin changes
•- Circumstances that do not guarantee the subject's ability to cooperate (compliance, self motivation, physical mobility, social environment)
•- Planned heart surgery, joint prosthetic or other mobility-restricting surgery in the next 3-months
•- Participation in another study with an active therapy arm
•- Missing hand-signed and dated consent

发起方

niversitätsklinikum Bonn