Clinical trial NCT05206630: ED Physical Therapy for Chronic Low Back Pain
Official title: An Ancillary Cluster-Randomized Trial of Embedded Physical Therapy for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
chronic
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: 2022-01-25
Enrollment: 128
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 chronic low back pain, with a focus on improving patient functioning and reducing opioid use.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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: