Clinical trial NCT04921449: ED Physical Therapy for Acute Low Back Pain
Official title: A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
physical therapy
emergency department
functioning
disability
opioid
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-06-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Pain Interference (PROMIS-PI)
timeFrame: Three months after the index ED visit.
Secondary outcomes:
measure: Modified Oswestry Disability Index (ODI)
timeFrame: Three months after the index ED visit.
measure: Patient-Reported Opioid Use in Last 24 Hours
timeFrame: Three months after the index ED visit.
Other outcomes:
measure: Opioid Prescription Filling
timeFrame: Three months after the index ED visit.
measure: Patient-Reported Prescription Analgesic Use in Last 24 Hours
timeFrame: Three months after the index ED visit.
measure: Prescription Analgesic Filling
timeFrame: Three months after the index ED visit.
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Three months after the index ED visit.
measure: Global Rating of Change (GROC)
timeFrame: Three months after the index ED visit.
measure: Pain Catastrophizing Scale (PCS-4)
timeFrame: Three months after the index ED visit.
measure: Pain Self-Efficacy Questionnaire (PSEQ-4)
timeFrame: Three months after the index ED visit.
measure: Advanced Healthcare Resource Utilization
timeFrame: Three months after the index ED visit.
measure: ED Diagnostic Imaging Utilization
timeFrame: Index ED 1 day visit.
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Howard S Kim, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HS, Muschong KM, Fishman IL, Schauer JM, Seitz AL, Strickland KJ, Lambert BL, McCarthy DM, Vu MH, Ciolino JD. Embedded emergency department physical therapy versus usual care for acute low back pain: a protocol for the NEED-PT randomised trial. BMJ Open. 2022 May 24;12(5):e061283. doi: 10.1136/bmjopen-2022-061283.