A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- PROMIS Pain Interference (PROMIS-PI)
研究概览
简要总结
Emergency department (ED)-initiated physical therapy is a rapidly growing resource and represents a promising treatment approach to low back pain. This clinical trial will evaluate an innovative model of an emergency department "embedded" physical therapist to treat patients with acute low back pain, with a focus on improving patient functioning and reducing opioid use.
详细描述
Low back pain represents a significant health care burden in the United States and accounts for nearly four million emergency department (ED) visits per year. In nearly two thirds of these visits, an opioid medication is administered or prescribed, making low back pain the most common reason for which opioids are prescribed. Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients report persistent functional impairment, and one in five patients report continued opioid use.
ED-initiated physical therapy (ED-PT) is a promising new resource to improve patient care for low back pain. A growing number of EDs now have dedicated physical therapists that evaluate and treat patients through a combination of education, prognostic guidance, and early mobilization and exercise. Preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement and use fewer opioids. However, these observational data are limited by biases in treatment selection due to physician discretion in which patients receive ED-PT, as well as other measured and unmeasured confounders.
To more rigorously evaluate the efficacy of ED-PT for acute low back pain, the investigators will conduct a single-center physician-randomized trial of an embedded physical therapy intervention (NEED-PT) versus usual care in ED patients with acute low back pain, comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at the primary endpoint of three months.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Low back pain (originating between 12th rib and buttocks)
- •Symptom duration ≤ 30 days (current episode)
- •Evaluated by a physician randomized to either study arm
- •Evaluated when ED physical therapy is available (e.g., Mon-Fri, 8am-4pm)
- •Likely to be discharged home (based on physician assessment)
- •Ability to complete follow-up data collection electronically or by telephone
- •English-speaking
排除标准
- •Chronic low back pain or prior lumbar surgery
- •Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
- •Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)
- •Other concomitant injuries or pain (e.g., closed head injury, shoulder pain)
- •Unable to ambulate at baseline
- •Known pregnancy, under police custody, unable to consent
结局指标
主要结局
PROMIS Pain Interference (PROMIS-PI)
时间窗: Three months after the index ED visit.
PROMIS-PI measures the self-reported consequences of pain on relevant aspects of a person's life, including social, cognitive, emotional, physical, and recreational activities. We will use the computer-adaptive format to minimize respondent burden. Scores are standardized to the general U.S. population, with a score of 50 representing the population mean. The time frame of interest for the PROMIS-PI is "in the past 7 days," meaning that participants provide responses based on their symptoms over the last week.
次要结局
- Patient-Reported Opioid Use in Last 24 Hours(Three months after the index ED visit.)
- Modified Oswestry Disability Index (ODI)(Three months after the index ED visit.)
研究者
Howard Kim
Assistant Professor
Northwestern University
