Gray Leigh A, Jarvik Jeffrey G, Heagerty Patrick J, Hollingworth William, Stout Lydia, Comstock Bryan A, Turner Judith A, Kallmes David F
Department of Radiology, Mayo Clinic College of Medicine, Rochester, MN, USA.
BMC Musculoskelet Disord. 2007 Dec 20;8:126. doi: 10.1186/1471-2474-8-126.
The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure.
METHODS/DESIGNS: Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month.
Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty.
Current Controlled Trials ISRCTN81871888.
在历史上，疼痛性骨质疏松性椎体压缩骨折的治疗方法局限于数周的卧床休息、抗炎和止痛药物、降钙素注射或外部支具固定。经皮椎体成形术（向骨折的椎体注射骨水泥）是一种用于治疗这些骨折的相对较新的手术方法。人们越来越关注经皮椎体成形术的疗效和安全性，并研究是否存在安慰剂效应，或者疼痛缓解是否源于椎体成形术过程中直接注射在骨头上的局部麻醉剂。
方法/设计：我们的目标是检验以下假设：与接受对照干预的患者相比，接受椎体成形术的疼痛性骨质疏松性椎体压缩骨折患者在1个月时的残疾程度和疼痛程度更低。对照干预是在骨折部位附近注射局部麻醉剂，不注射骨水泥。将在5年时间里从美国和国外开展椎体成形术的机构招募166例疼痛性骨质疏松性椎体压缩骨折患者。我们将排除有恶性肿瘤沉积（多发性骨髓瘤）、肿瘤肿块或肿瘤延伸至骨折部位硬膜外间隙的患者。我们将随机分配参与者接受椎体成形术或对照干预。受试者将在基线以及随机分组后的时间点（第1、2、3和14天，以及第1、3、6和12个月）完成一系列经过验证的、标准化的疼痛、功能残疾和健康相关生活质量测量。进行随访评估的受试者和研究访谈者都将对随机分组情况不知情。受试者将在第1个月和第12个月进行门诊就诊。在研究结束时（第12个月）获取脊柱X光片以确定后续骨折发生率。我们的共同主要结局是1个月时的改良罗兰评分和疼痛数字评定量表。
尽管在北美广泛用于缓解疼痛，但椎体成形术仍未经过严格研究。上述研究是第一项能够解释椎体成形术背景下安慰剂效应的随机对照研究。
当前受控试验ISRCTN81871888。
