2.2. Efficacy Evaluation
disability or functional impairment, low back pain, Oswestry Disability, pain
ADVERSE EVENT, ADVERSE EVENT
At baseline, patients scored their back pain using the visual analog scale (VAS, on a scale of 0 to 100, with higher scores indicating more severe pain) and completed self-reported questionnaires, such as the Oswestry Disability Index (ODI) and the 5-level version of the European Quality of Life-5 (EQ-5D). The ODI is a widely used questionnaire designed to assess the level of disability or functional impairment experienced by individuals with low back pain. The EQ-5D score is a standardized instrument used to measure health-related quality of life. It assesses an individual’s general health and well-being and is commonly used in healthcare and clinical research to evaluate the overall health status and quality of life of patients. They also provided their demographic and clinical information. Evaluation measures were performed before randomization and at various times for up to 3 months. The primary outcome measure was the VAS pain score of the back. Secondary outcome measures included ODI and EQ-5D scores.The compression rate and wedge angle of the vertebral body were measured on plain radiographs [At the first visit, written informed consent, demographic information, medical history, medications, smoking status, and vital signs were obtained, and bone density scan, VAS, ODI, EQ-5D questionnaires, and radiologic examinations were conducted. On day 1 (visit 2), vital signs, VAS, ODI, and adverse event monitoring were performed. Visit 3 (at week 1) included vital signs, VAS, ODI, and adverse event monitoring, The fourth and fifth visits, at weeks 4 and 12, involved vital signs, VAS, ODI, EQ-5D, X-ray, and adverse event monitoring. Adverse events (AEs), vital signs, and physical examination were assessed. An adverse event is defined as a compression rate of 80% or more or a VAS pain score of 8 or higher.