ED Physical Therapy for Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

An Ancillary Cluster-Randomized Trial of Embedded Physical Therapy for Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206630
• Other study ID #: STU00213134
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: Howard S Kim, MD MS
• Phone: 312-926-0591
• Email: howard.kim[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• ED Physical Therapy
All ED Physical Therapy treatment classifications involve a combination of exercise, range of motion, education, prognostic guidance, and reassurance. Patients are provided with an individualized home exercise plan based on their matched treatment classification and/or active rest.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid Prescription Filling	Opioid prescription filling data will be queried in the state prescription monitoring database.	Three months after the index ED visit.
Other	Patient-Reported Prescription Analgesic Use in Last 24 Hours	Patient-reported prescription analgesic use will be collected using the same customized instrument described above for opioid use. Prescription analgesics include the following: opioids, benzodiazepines, skeletal muscle relaxants, and gabapentinoids.	Three months after the index ED visit.
Other	Prescription Analgesic Filling	Prescription analgesic filling data will be queried in the state prescription drug monitoring database. Prescription analgesics include opioids, benzodiazepines, skeletal muscle relaxants, and gabapentinoids.	Three months after the index ED visit.
Other	Numeric Pain Rating Scale (NPRS)	The NPRS measures pain intensity from 0 to 10 (higher score indicates higher intensity) and is easily understood by laypersons, clinicians, and researchers. The investigators will assess a single item relating to average pain intensity over the last 24 hours.	Three months after the index ED visit.
Other	Global Rating of Change (GROC)	The GROC is a single-item survey used to evaluate overall recovery from low back pain from "the time that you began having pain until now." Responses are provided on a 15-point Likert scale ranging from "a very great deal worse" to "a very great deal better" (higher scores indicate better outcome).	Three months after the index ED visit.
Other	Pain Catastrophizing Scale (PCS-4)	The original PCS is a 13-item survey measuring the degree to which an individual catastrophizes in response to pain. PCS scores correlate closely with pain intensity and disability over time; higher PCS scores are associated with progression from acute to chronic pain. The investigators will utilize the brief 4-item PCS measure containing original items 3, 6, 8, and 11 (total score range 0-16, higher score indicates higher catastrophizing).	Three months after the index ED visit.
Other	Pain Self-Efficacy Questionnaire (PSEQ-4)	The original PSEQ is a 10-item survey measuring the confidence with which individuals can do things despite pain. The investigators will utilize the brief 4-item PSEQ measure containing original items 4, 6, 8, and 9 (total score range 0-24, higher score indicates higher confidence).	Three months after the index ED visit.
Other	Advanced Healthcare Resource Utilization	The investigators will assess the proportion of participants who utilized any advanced healthcare resources for low back pain after their index ED visit, defined as advanced imaging (e.g., magnetic resonance imaging) or procedures/surgery (e.g., epidural steroid injection, lumbar discectomy).	Three months after the index ED visit.
Other	ED Diagnostic Imaging Utilization	The investigators will assess the proportion of ED visits in which any diagnostic imaging of the lower back was performed, including plain radiography, computed tomography, or magnetic resonance imaging.	Index ED 1 day visit.
Primary	PROMIS Pain Interference (PROMIS-PI)	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.	Three months after the index ED visit.
Secondary	Modified Oswestry Disability Index (ODI)	The ODI contains 10 questions relating to low back pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. The ODI score ranges from zero (no disability) to 100 (maximum disability). The time frame of interest for the ODI is "today," meaning that participants provide responses based on their current symptoms on the day of survey response. The modified ODI replaces an item from the original ODI pertaining to sex life with a new item pertaining to employment/homemaking.	Three months after the index ED visit.
Secondary	Patient-Reported Opioid Use in Last 24 Hours	Patient-reported opioid use will be collected using a customized instrument assessing whether participants have taken any opioid medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall and has been used previously. In brief, opioid medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., oxycodone 10mg) and quantity (e.g., four pills), allowing for standardization by morphine milligram equivalents.	Three months after the index ED visit.