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 Phenomeno
- Conditions
- Raynaud's phenomenonChronic pain
- Registration Number
- DRKS00030179
- Lead Sponsor
- niversitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in severity and frequency of Raynaud attacks will be assesses by paper CRFs at 3-months.
- Secondary Outcome Measures
Name Time Method Evaluate the effect of CL-SCS on:<br>- Symptoms associated with RP (Raynaud symptom map, Raynaud's Condition Score (RCS), VAS for pain)<br>- Health related quality of life (EQ-5D-5L)<br>- Function (Cochin Hand function Scale, SHAQ)<br>- Peripheral circulation (doppler ultrasound, ulcers)<br>- Subject satisfaction (PGIC scale)<br>- Medication (changes in types and dosages)<br>- Stimulation programming characteristics (stimulation settings)<br>- Safety (incidence device related adverse events)