Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-informed telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.
Primary care visit in the past 90 days with an LBP-related International Classification of Diseases (ICD-10) diagnosis.
Age 18 years or older.
At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem? and 2) How often has LBP been an ongoing problem over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
Recent history (last 6 months) of lumbar spine surgery.
Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).
Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.
Parallel
Standardized Education
BehavioralPatients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest.
Telerehabilitation
BehavioralBased on prior SBTS risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to PIPT telehealth visits (high-risk).
Change in Oswestry Disability Index
LBP-related disability. The total score range is \[0, 100\] with higher values representing greater pain-related disability.
Participants with Opioid Use
self-reported and/or Electronic Health Record (EHR) documented opioid use
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Gender
Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group
Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Baseline Opioid Use
Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.
Percent of patients approached who accept participation
Implementation - Acceptability as assessed by percent of patients approached who accept participant
Percent of patients offered telerehabilitation
Implementation - Adoption as assessed by percent of patients offered tele-rehabilitation
Percent of intervention sessions completed
Implementation - Feasibility as assessed by percent of intervention sessions completed
Percent of core treatment components provided during intervention sessions
Implementation - Fidelity as assessed by percent of core treatment components provided during intervention sessions
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
TidalHealth, Inc.
Collaborator
Medstar Health Research Institute
Collaborator
Maryland Rural Health Association
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
