Department of Orthopedics and Research School CAPHRI, Maastricht University Medical Center+, Maastricht, The Netherlands
Department of Orthopedics and Research School CAPHRI, Maastricht University Medical Center+, Maastricht, The Netherlands.
BMJ Open. 2022 May 24;12(5):e054315. doi: 10.1136/bmjopen-2021-054315.
Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF.
Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months.
Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences.
NL8746.
骨质疏松症患者在轻微创伤后可能会发生骨折。骨质疏松性椎体压缩性骨折（OVCFs）是最常见的骨折之一，常导致严重疼痛。需要有循证的保守治疗方法来帮助管理 OVCFs。本随机对照试验（RCT）的目的是评估动态支具在标准治疗基础上对改善 OVCF 患者生活质量（QoL）的有效性和成本效益。
98 名来自两家学术医院和四家社区医院的近期有症状胸腰椎 OVCF 的绝经后妇女将被随机分为标准治疗组或动态支具组。在动态支具组中，除标准治疗外，还将使用 Spinova Osteo 矫形器。标准治疗包括疼痛控制（镇痛药）、物理治疗和骨质疏松症药物治疗。主要结局参数是纳入后 1 年的 QoL，通过欧洲骨质疏松症基金会生活质量问卷（QUALEFFO-41）进行评估。次要结局参数是疼痛、使用的止痛药物、功能障碍、矢状位脊柱排列、OVCF 复发率和日常生活中的体力活动。根据 RCT 中获得的经验数据，将进行基于试验的经济评估，包括成本效益分析和成本效用分析。流程评估将评估动态支具的可行性。所有结局将在基线、6 周、3 个月、6 个月、9 个月和 12 个月时进行评估。
Maastricht 大学医院和 Maastricht 大学医学伦理委员会（METC azM/UM）（NL74552.068.20/METC 20-055）已批准伦理。只有在确认符合条件并获得书面知情同意后，才能纳入患者。结果将通过荷兰国家骨质疏松症患者协会以及出版物和会议进行传播。
NL8746。
