2.5. Data collection and management
DISEASE
An electronically generated Case Report Form will be used and managed by qualified and authorized investigators and physicians. All the data recorded in the electronically generated Case Report Form will be consistent with those of the original material. During the study, the investigator will collect data at each visit. All study findings and records will be treated with strict confidentiality, and patients are to be identified solely by their patient number and/or birth date, and never by name. To protect participant anonymity, the investigator will maintain the confidentiality of the patient-identifying documents. The following data will be collected.Date of birth (age), sex, medical history, history of current disease, and pregnancy status.Body weight and height at first visit, including BMI calculations.Vital signs (body temperature [°C], blood pressure [mm Hg], pulse rate [beats/minute]) at every visit.SWE before and after each treatment.NRS score at screening and visits 1, 4, and 5.Oswestry Disability Index and EQ-5D index at visits 1, 4, and 5.Patient Global Assessment at screening visits, and visits 1, 4, and 5.Outlier detection for each procedure.Additionally, an independent clinical research organization will conduct data management and data monitoring. Interim analyses will not be conducted, and the trial will be terminated by the principal investigator when the study process for all enrolled study participants has been completed.