The design and execution of the International Neuromodulation Society (INS) registry has been developed with the objective of assessing the efficacy and safety of Spinal Cord Stimulation and other neuromodulation therapies using real world data. The analysis of this registry as a data source will inform which therapies and devices are effective across clinics and participating countries. It is designed to combine data across multiple countries to enable research, benchmarking and device surveillance, and support for implant recalls. By combining longitudinal patient outcomes, device-level surveillance, and cross-center benchmarking, the registry will provide a powerful resource for evidence-based decision-making and international collaboration.
Study Type
OBSERVATIONAL
Enrollment
1,000
Spinal cord stimulation (SCS) procedures
Quality of life
The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: 12 Months
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