我们的研究旨在评估比较脊髓内侧支神经根阻滞干预与标准治疗椎体成形术治疗脆弱的疼痛性骨质疏松性椎体骨折的可行性结果。住院的老年患者。我们发现这项研究是可行的,现在提出了临床有效性,成本效益和安全性评估。
背景:椎体成形术(VP)是一种关键孔程序,涉及将骨水泥注入骨折的椎体,减轻疼痛,增加椎体稳定性,尽管它与并发症的风险很小有关,特别是在虚弱的时候,老年住院患者。内侧支脊髓神经阻滞(MBNB)可能是缓解疼痛症状的替代治疗方法。并发症少;然而,没有研究前瞻性地比较临床有效性,MBNB至VP的成本效益和安全性,在脆弱的,老年住院患者。我们研究的目的是进行第一阶段的可行性研究,探索招聘,保留率和几个结果度量(均值和SDs),与定性访谈一起评估参与者和临床医生的观点,告知一个明确的更大的研究。
方法:我们进行了一项双臂可行性随机对照试验,参与者被分配继续接受常规手术治疗-VP或MBNB治疗。进行嵌入式定性研究。数据是在基线时收集的,第1周、第4周和第8周。
结果:在40名符合条件的患者中,30人(75%)同意参加研究。从随机分组到干预的总中位时间为3天,IQR1-7天,VP为5(1-7)天,MBNB为2(1-3)天。VP组的住院时间中位数(IQR)为20(8)天,MBNB为15(22)天。在第1周、第4周和第8周,结果数据收集的完整性比例至少为77%:14(100%),VP为12(85.7%)和11(78.9%),VP为13(100%),MBNB为12(92.3%)和10(76.8%),分别。两组的临床结局和不良事件无显著差异。
结论:我们的研究在实现目标招聘方面是可行的,参与者坚持随机分组,8周结束时数据的完整性至少为77%(目标75%).我们现在计划进行明确的临床疗效,成本效益和安全性结果研究,将VP与MBNB进行比较,老年患者因急性椎体骨质疏松性骨折住院。
Our study aimed to assess the feasibility outcomes comparing spinal medial branch nerve root block intervention to standard care vertebroplasty for the treatment of painful osteoporotic vertebral fractures in frail,
hospitalised older patients. We found the study to be feasible and now propose a clinical effectiveness, cost effectiveness and safety evaluation.
Vertebroplasty (VP) is a key-hole procedure involving injection of bone cement into a fractured vertebral body, to reduce pain and increase vertebral body stability, although it is associated with a small risk of complications, particularly in frail, older
hospitalised patients. Medial branch spinal nerve block (MBNB) may be an alternative treatment to alleviate pain symptoms, with less complications; however, no study has prospectively compared the clinical effectiveness, cost-effectiveness and safety of MBNB to VP, in frail, older
hospitalised patients. The aim of our study was to conduct a 1st stage feasibility study, exploring recruitment, retention and several outcomes measures (means and SDs), together with qualitative interviews to assess participant and clinician views, to inform a definitive larger study.
We conducted a two-arm feasibility randomised controlled trial with participants allocated to continue with routine surgical care-VP or MBNB treatment, with an embedded qualitative study. Data was collected at baseline, week 1, 4, and week 8.
Out of 40 eligible patients, 30 (75%) consented to take part in the study. The overall median time from randomisation to intervention was 3 days, IQR 1-7 days, 5 (1-7) days for VP and 2 (1-3) days for MBNB. Median (IQR) length of hospital stay for the VP group was 20 (8) days and for the MBNB 15(22) days. The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%: 14 (100%), 12 (85.7%) and 11(78.9%) for VP and 13 (100%), 12 (92.3%) and 10 (76.8%) for MBNB, respectively. There were no significant difference in the clinical outcomes or adverse events between the two groups.
Our study was feasible in achieving is target recruitment, participants adhered to the randomisation and at least 77% completeness of data at the 8 week end-point (target 75%). We now plan to conduct a definitive clinical effectiveness, cost effectiveness and safety outcome study, comparing VP to MBNB in frail, older patients
hospitalised with an acute vertebral osteoporotic fracture.