Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation: a Prospective Real-world Data Collection With Pre-determined Follow-up Moments

What this Trial Is About

Researchers are conducting a long-term observational study to collect detailed data on patients with spinal diseases undergoing various non-invasive and invasive treatments, including neuromodulation. The study aims to create patient profiles, optimize treatment flows and strategies based on outcomes, and share knowledge with healthcare professionals. It also seeks to monitor complications and support health-economic analyses through data collected at predetermined follow-up times. Participants in this study will not receive experimental treatments but will provide information through questionnaires and clinical data collection during routine visits at spine departments. Data include patient demographics, medical history, symptoms, imaging results, treatments, and outcomes from both non-invasive and invasive procedures such as injections, surgery, and neuromodulation therapies. Questionnaires will be completed digitally on provided devices or on paper if needed, with follow-ups scheduled at about 6 weeks, 6 months, and yearly after treatment. Throughout the study, patients will be asked to complete various standardized questionnaires assessing pain, disability, and quality of life, including the Visual Analogue Scale for pain and Oswestry Disability Index. Clinical data and treatment details are collected and securely stored in a coded database accessible only to treating physicians. The study will measure outcomes over time to understand treatment effectiveness and patient flow, with no specific target enrollment number and ongoing data analysis planned.

Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation