Introduction: Osteoporotic vertebral fractures (OVF) worsen the QOL in the elderly, due to residual lower back pain and spinal deformity. The major conservative treatment could be using some brace. Then, we performed a nationwide multicenter, cohort study to compare the effects of hard and soft braces, and to establish an ideal initial brace treatment for OVF. And also we conducted a follow-up study to investigate the non-union rate and the long-term course of an acute vertebral fracture in terms of pain and quality of life.
Materials and Methods: This study included 65-85 years female patients with acute one-level osteoporotic compression fractures. In the radiographic analysis, the anterior vertebral body compression percentage was measured at 0, 12, and 48 weeks. Magnetic resonance imaging (MRI) was performed at enrollment and at 48 weeks to confirm the diagnosis and union status.
The primary outcome measure was the anterior vertebral body compression percentage (AVBCP) at 1 year. Secondary outcome measures included scores on the European Quality of Life-5 Dimensions (EQ-5D-3L), visual analogue scale (VAS) for low back pain, and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) at 48 weeks follow-up duration. Then, we conducted a follow-up study to investigate the long-term course in terms of pain and quality of life.
Results: 284 patients who were randomized (mean age 75.7 years), 80% (228/284) of available study participants completed the trial. The 12-week hard brace treatment did not result in statistically greater prevention of spinal deformity than soft brace at 48-week after brace application. VAS, QOL were also not different. We found that the 12-week rigid-brace treatment for acute vertebral compression fractures did not result in statistically greater prevention of spinal deformity, better QOL, or lesser back pain than soft-brace treatment at 48 weeks. When comparing VAS for low back pain and EQ-5D between consecutive time points, a significant difference was found between 0 and 12 weeks, but not between 12 and 48 weeks or between 48 weeks and final follow-up. A total 25% had residual low back pain at the final follow-up. A stepwise logistic regression analysis identified age and previous vertebral fracture as predictors of residual low back pain at the final follow-up.
Patients with nonunion at 48 weeks after OVF had lower EQ-5D and JOABPEQ walking ability, social life function, mental health, and lumbar function scores than those with union at 48 weeks after injury. The independent risk factors for nonunion after OVF in the acute phase were a diffuse low type pattern on T1-weighted MRI and diffuse low and fluid type patterns on T2-weighted MRI. The anterior vertebral body compression percentage and JOABPEQ social life function scores were independent risk factors at 12 weeks.
Therefore, the degree of low back pain and impairment of the quality of life improved by 12 weeks after injury and did not change thereafter until a mean follow-up of 5.3 years.
Conclusion: Patients who have acute OVFs with these risk factors should be carefully monitored for nonunion and rigid low back pain.