2.1. Study Design and Participants
bleeding, VCFs, bone density, fracture, pain, osteoporotic VCFs
BLEEDING, BONE MARROW EDEMA, MAY, COAGULATION DISORDER, MALIGNANT TUMOR, INFLAMMATORY DISEASE, COMPRESSION FRACTURES
The participants were enrolled at a tertiary education hospital between June 2017 and May 2020. This trial was approved by the institutional review board of our hospital (B-1502-288-005) and registered at The participants were recruited from the outpatient department of our hospital by a single specialist. The inclusion criteria were as follows: (1) aged ≥ 40 years and voluntarily agreed to participate and (2) diagnosed with one to three painful osteoporotic VCFs between vertebral levels T10 and L5. In all patients with suspected compression fractures, lumbar X-rays and MRI were performed to confirm the fracture and bone marrow edema. Also, in all patients diagnosed with VCFs, bone density scans were performed to confirm osteoporotic VCFs. The exclusion criteria were as follows: (1) previous diagnosis of an inflammatory disease or malignant tumor, (2) presence of a bleeding or coagulation disorder, (3) use of any type of anticoagulant, (4) severe pain other than in the lower back, and (5) deemed unfit for participation in this clinical trial by the researcher.Participants who met the inclusion criteria were randomized into one of two treatment groups at a 1:1 ratio: the core decompression group and the conservative treatment group. The time from fracture to randomization was less than one month. Web-based randomization was employed to achieve concealed allocation. All participants were evaluated for the efficacy and safety of the treatment over a 3-month study period.