Validation of the STarT Back Screening Tool in the Primary Care Management of Low Back Pain in the Military Health System: A Randomized Trial of Risk-stratified vs. Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Roland-Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military Health System for patients with low back pain presenting to primary care.
详细描述
Subjects with low back pain presenting to primary care will be enrolled in a study that aims to evaluate the utility of the SBST for providing risk-stratified care. The concept of this approach revolves around matching treatment to patients based on their risk for developing chronic disability from back pain. Those at low risk receive less treatment, and those at high risk need more specialized treatment, that includes psychosocially-focused and cognitive considerations. This approach will be compared to usual care, where general practitioners carry out the course of action they think best for each patient, without any other guidance. Patients will be followed for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Primary care providers will be unaware of risk stratification scores.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females who are between the ages of 18-50 years old
- •Primary complaint of LBP for any duration, with or without associated radiculopathy
- •Can speak and understand English
- •Be willing and able to give full, informed written consent
排除标准
- •Red Flags: Any potentially serious or systemic disorders (e.g., cauda equina compression, inflammatory arthritis, compression fracture, malignancy, infection, severe neurological progression), serious illness or comorbidity
- •Spinal surgery in the past 24 months
- •Current pregnancy (or within the last 6 months)
- •Already receiving treatment (other than primary care) for this episode of LBP
- •Inability to attend regular treatment sessions
- •Pending litigation or a medical evaluation board
研究组 & 干预措施
Usual Care
- "Managing Low Back Pain" pamphlet from DoD/VA
- No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
干预措施: Usual Care (Procedure)
Risk Stratified Care
- "Managing Low Back Pain" pamphlet from DoD/VA
- Self-management education and tools
- 2-item spinal manipulation screening/delivery if indicated
Low Risk:
- Home Exercise Program as indicated
- No referral for ongoing physical therapy
Medium Risk and High Risk
- Referral to physical therapy for ongoing care at physical therapists discretion
- Managed by a "psychologically informed physical therapy" trained physical therapist
干预措施: Risk Stratified Care (Procedure)
结局指标
主要结局
Roland-Morris Disability Questionnaire (RMDQ)
时间窗: 1 year
The RMDQ measures low back pain related disability by prompting the participant using 24 statements. The score ranges from 0 to 24 with higher scores indicating greater disability
次要结局
- Patient Acceptable Symptom Scale (PASS)(1 year)
- Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57)(1 year)
- Credibility Expectancy Questionnaire (CEQ)(1 year)
- Healthcare Utilization(2 years)
- EuroQoL (EQ-5D)(1 year)
研究者
Dan Rhon
Director of Clinical Outcomes Research at the Center for the Intrepid
Brooke Army Medical Center