Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,239
- 试验地点
- 3
- 主要终点
- Change in Roland- Morris Disability Questionnaire
研究概览
简要总结
The overall objective of BOLD is to establish a large, community-based registry (at least 5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for back pain in older adults.
详细描述
The BOLD registry identifies subjects at the time of a new episode of back pain and captures data in a longitudinal fashion for up to 12 months. The registry captures self-report outcomes data as well as comprehensive utilization data including pharmacy and imaging data through the electronic medical record system. We are applying for additional funding to continue follow-up for up to 4 years from baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 65 years
- •Primary care visit for low back pain based on ICD9 code
- •No prior visits for low back pain within six months
排除标准
- •Prior lumbar spine surgery
- •Developmental spine deformities
- •Inflammatory spondyloarthropathy
- •Known spinal malignancy or infection
- •Primarily nerve compression-related symptoms
- •Serious medical co-morbid condition with life expectancy < 1yr
- •No telephone, or planning to move within a year
- •Unable to understand English
- •Severe mental impairment that would interfere with answering questions
结局指标
主要结局
Change in Roland- Morris Disability Questionnaire
时间窗: Baseline, 3, 6 and 12 month timepoints
24-item back pain specific, functional status questionnaire
次要结局
- Change in Brief Pain Inventory(Baseline, 3, 6 and 12 month timepoints)
- Demographics(Baseline)
- Change in Pain Numerical Rating Scale (NRS)(Baseline, 3, 6 and 12 month timepoints)
- Change in Patient Expectation Regarding Recovery(Baseline, 3, 6 and 12 month timepoints)
- Change in Patient Health Questionnaire-4 (PHQ-4)(Baseline, 3, 6 and 12 month timepoints)
- Change in Falls Assessment(Baseline, 3, 6 and 12 month timepoints)
- Electronic Medical Record Data(12 months before and after index visit for back pain)
- Change in Euro-Qual-D (EQ-5D)(Baseline, 3, 6 and 12 month timepoints)
研究者
Jeffrey G. Jarvik, MD, MPH
Professor
University of Washington