A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- PROMIS Pain Interference (PROMIS-PI)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Embedded ED Physical Therapy (NEED-PT)
An ED physical therapist will be embedded with the primary treatment team to evaluate patients presenting with low back pain at the beginning of the overall treatment course. The physical therapist will utilize a clinical protocol (NEED-PT) that matches the patient's history and exam findings to an appropriate treatment classification consisting of directional preference exercises, manual traction, stabilization exercises, non-thrust manipulation/mobilization, and/or psychologically informed rehabilitation. The NEED-PT intervention will supplement any usual care performed by the treating physician.
Intervention: ED Physical Therapy (Other)
Usual Care
Usual care consists of any ED testing or treatment not involving an ED physical therapist in accordance with the treating physician's usual and customary practice. This could include diagnostic imaging, patient education and reassurance, and administration and/or prescribing of analgesic medications.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
PROMIS Pain Interference (PROMIS-PI)
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Howard Kim
Assistant Professor
Northwestern University