Improving Health for Patients With Chronic LBP in Rural Communities Through Telerehabilitation
NCT Number: NCT06471920
Acronym: ARBOR-Th
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: BEHAVIORAL: Educational Control|BEHAVIORAL: Telerehabilitation
Sponsor: Johns Hopkins University
Collaborators: Tidalhealth, Inc.|Medstar Health Research Institute|Maryland Rural Health Association|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 434
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-08-31
Locations: Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287, United States|Tidalhealth, Salisbury, Maryland, 21801, United States

Summary:
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 single-masked prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-stratified 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 Outcome Measures: Change in Oswestry Disability Index, LBP-related disability. The total score range is \[0, 100\] with higher values representing greater pain-related disability., Change from baseline to 8 weeks after treatment initiation|Opioid Use, self-reported and/or Electronic Health Record (EHR) documented opioid use, Proportion using opioids at 8 weeks after treatment initiation
Secondary Outcome Measures: 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 from baseline to 16- and 52-weeks after treatment initiation|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 from baseline to 16- and 52-weeks after treatment initiation|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 from baseline to 16- and 52-weeks after treatment initiation|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., Change from baseline to 16- and 52-weeks after treatment initiation|Change in PROMIS Preference Score (PROPr), Total score range is \[0, 100\] with higher scores indicating better outcome., Change from baseline to 16- and 52-weeks after treatment initiation|Change in PROMIS Preference Score (PROPr) by Gender, Total score range is \[0, 100\] with higher scores indicating better outcome., Change from baseline to 16- and 52-weeks after treatment initiation|Change in PROMIS Preference Score (PROPr) by Age Group, Total score range is \[0, 100\] with higher scores indicating better outcome., Change from baseline to 16- and 52-weeks after treatment initiation|Change in PROMIS Preference Score (PROPr) by Baseline Opioid Use, Total score range is \[0, 100\] with higher scores indicating better outcome., Change from baseline to 16- and 52-weeks after treatment initiation|Percent of participants using non-opioid LBP-Related Healthcare Use, Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery), 16- and 52-weeks after treatment initiation|Percent of participants using non-opioid LBP-Related Healthcare Use by Gender, Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery), 16- and 52-weeks after treatment initiation|Percent of participants using non-opioid LBP-Related Healthcare Use by Age Group, Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery), 16- and 52-weeks after treatment initiation|Percent of participants using non-opioid LBP-Related Healthcare Use by Baseline Opioid Use, Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery), 16- and 52-weeks after treatment initiation
Other Outcome Measures: Percent of patients approached who accept participation, Implementation - Acceptability as assessed by percent of patients approached who accept participant, At Screening|Percent of patients offered telerehabilitation, Implementation - Adoption as assessed by percent of patients offered tele-rehabilitation, At screening|Percent of intervention sessions completed, Implementation - Feasibility as assessed by percent of intervention sessions completed, 8-weeks after treatment initiation|Percent of core treatment components provided during intervention sessions, Implementation - Fidelity as assessed by percent of core treatment components provided during intervention sessions, 8-weeks after treatment initiation