LOW BACK PAIN--A MULTICENTER RANDOMIZED TRIAL

下背痛被认为是美国和世界上最普遍的健康问题之一。 这种情况仅次于普通感冒，是患者最常去看医生或失去工作的情况。 据估计，那些因腰痛而严重残疾的人每年的费用在300亿至700亿美元之间。 随着时间的推移，美国的脊柱手术率急剧增加，这些手术率的地理差异已被记录为15倍。 在许多情况下，手术的比率似乎取决于一个人住在哪里，和谁见面。 尽管有这些趋势，但几乎没有证据证明这些疗法的有效性/疗效优于非手术治疗。 本研究将利用国家脊柱网络的独特资源，对进行脊柱手术的三个最常见诊断组进行多中心、随机、对照试验：腰椎间盘突出症（IDH）、椎管狭窄症（SpS）和继发于退行性脊椎滑脱症（DS）的椎管狭窄症。这些试验将比较最常用的标准手术治疗与最常用的标准非手术治疗。 该研究将在美国的16个研究中心进行。本研究的主要终点将是通过SF-36健康状态问卷测量的一般健康相关生活质量的变化和通过奥斯韦斯特里腰痛问卷测量的脊柱相关残疾。 次要终点将包括患者对治疗的满意度、用于估计成本的资源利用率以及用于估计质量调整生命年（Qs）的当前健康状况的效用。后两个终点将用于完成正式的成本效益评价。 患者将接受至少24个月的随访，计划在3、6、12和24个月进行访视。 将在每次研究访视时收集所有终点的数据。 如果可能，将在36个月和48个月时安排延长随访访视。 我们预计将入组并随机分配共计1450例受试者。 将跟踪另一个观察性队列，以评估健康和资源结果。 将整合RCT和观察性队列的数据，以正式估计IDH、SpS和DS手术与非手术干预的成本-效果。 基于这项试验，我们将首次获得关于手术与非手术治疗这三种常见腰椎疾病的相对有效性/疗效的科学证据。

Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. This condition is second only to the common cold as the condition for which patients most frequently see a physician or suffer days lost from work. Estimated costs to those who are severely disabled from low back pain range from 30-70 billion dollars annually. Rates of spinal surgery in the U.S. have increased sharply over time, and 15-fold geographic variation in rates of these surgeries has been documented. In many cases the rates of surgery appear to be determined by where one lives and who one sees. Despite these trends, there is little evidence proving the effectiveness/efficacy of these therapies over non-operative management. This study will use the unique resource of the National Spine Network to conduct multicentered, randomized, controlled trials for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS) and spinal stenosis secondary to degenerative spondylolithesis (DS). The trials will compare the most commonly used standard surgical treatments to the most commonly used standard non-operative treatments. The study will be conducted at 16 sites throughout the United States. The primary endpoints of the study will be changes in general health-related quality of life as measured by the SF-36 health status questionnaire and spine-related disability as measured by the Oswestry Low Back Pain questionnaire. Secondary endpoints will include patient satisfaction with treatment, resource utilization for estimation of cost, and utility for current health for estimation of quality-adjusted life years (QALYs). The latter two endpoints will be used to complete a formal cost-effectiveness evaluation. Patients will be followed a minimum of 24 months with visits scheduled at 3, 6, 12, and 24 months. Data on all endpoints will be collected at each study visit. If possible, extended follow-up visits will be scheduled at 36 and 48 months. We anticipate that a total of 1450 subjects will be enrolled and randomly allocated. An additional observational cohort will be tracked to assess health and resource outcomes. Data from the RCT and observational cohorts will be integrated to formally estimate the cost-effectiveness of operative versus non-operative interventions for IDH, SpS, and DS. Based on this trial we will, for the first time, have scientific evidence as to the relative effectiveness/efficacy of surgical versus non-surgical treatment for these three common lumbar spine conditions.