An Ancillary Cluster-Randomized Trial of Embedded Physical Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 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 chronic low back pain, with a focus on improving patient functioning and reducing opioid use.
详细描述
This trial is ancillary to an ongoing single-center physician-randomized trial of an embedded physical therapy intervention versus usual care in ED patients with acute low back pain (NEED-PT, NCT04921449), comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at three months. The main trial aims to enroll up to 360 participants with acute low back pain, defined as ≤ 30 days in duration and no history of lumber surgery or chronic low back pain. Using the same procedures and physician-randomization assignments as the main trial, this ancillary trial will enroll an additional 200 participants with chronic low back pain (i.e. non-acute low back pain) in order to obtain initial point estimates for the outcomes of interest and assess participant enrollment and retention rates in this population. The ancillary trial's sample size of 200 participants is an estimate of patient accrual over the anticipated remaining duration of the main trial (i.e., there is not a separate power calculation for this ancillary trial given its exploratory nature), and the actual number accrued may differ depending on the main trial's actual end date.
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)
- •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
- •Enrollment in the main trial (NEED-PT, NCT04921449)
- •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. The investigators 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
- Modified Oswestry Disability Index (ODI)(Three months after the index ED visit.)
- Patient-Reported Opioid Use in Last 24 Hours(Three months after the index ED visit.)
研究者
Howard Kim
Assistant Professor
Northwestern University