A Randomized Controlled Trial of Vertebral Body Decompression Procedure Versus Conservative Treatment for Painful Vertebral Compression Fracture.

Abstract

Background: Traditional treatment modalities for vertebral compression fractures (VCFs) include bed rest, pain medications, muscle relaxants, back braces, and physical therapy. In cases where conservative treatment proves ineffective, a new procedure called core decompression of the vertebral body is explored. Core decompression of the vertebral body has the potential to lower and stabilize the intraosseous pressure, resulting in enhanced blood circulation, which contributes to pain reduction. In this trial, we evaluated the efficacy of core decompression of the vertebral body in patients with painful VCFs compared with conventional conservative treatment. Methods: This prospective randomized controlled trial was conducted at a tertiary education hospital between June 2017 and May 2020. The participants were randomly assigned in a 1:1 ratio to one of two treatment groups: the core decompression group and the conservative treatment group. The primary outcome measure was the visual analog scale (VAS) pain score of the back 3 months after the procedure. Secondary outcome measures included the Oswestry Disability Index (ODI) for lumbar disabilities, the European Quality of Life-5 Dimensions (EQ-5D) score for quality of life, and radiographic outcomes such as changes in compression rate. Results: All patients underwent the assigned intervention (48 core decompression and 50 conservative treatments). At both 1 month and 3 months, there were no significant differences between the core decompression group and conservative treatment group in VAS pain score (adjusted treatment effect: -0.1 and 2.0; 95% confidence interval [CI]: -7.5 to 7.3 and -5.6 to 9.6; p = 0.970 and p = 0.601, respectively). In addition, there were no significant inter-group differences in ODI and EQ-5D scores throughout the follow-up period (p = 0.917 and 0.704, respectively). Conclusion: Core decompression of the vertebral body did not demonstrate any significant improvement in pain and disability compared to conventional conservative treatment.