Trial Summary

Chronic low back pain (LBP) imposes tremendous burden on affected individuals, healthcare systems, and society. LBP has been identified as the most common cause of disability globally and in the United States (US). LBP is also the largest driver of US healthcare spending ($135 billion in 2016) and the most common diagnoses associated with opioid prescription and consumption. For patients with chronic LBP, physical therapy has been shown to be a cost-effective method for improving pain and disability. In addition, physical therapy has been shown to decrease the risk of advanced imaging, injections, surgery, and opioid use in patients with chronic LBP. Despite available evidence in support, only 7-13% of patients with LBP, including those with chronic LBP, go on to receive physical therapy services, with patients reporting barriers accessing physical therapy, such as transportation, provider availability and missed work time. Access is especially limited in rural communities where there are approximately 40% fewer physical therapists available per capita compared to metropolitan regions. In addition, patients living in rural communities likely need to travel longer distances to receive physical therapy, requiring additional missed work time and transportation costs. This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas. Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US. Telehealth has rapidly expanded during the COVID-19 pandemic. This includes policy changes that have allowed physical therapists to begin providing care remotely, also referred to as telerehabilitation. Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients. We will conduct a single-blind prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-stratified telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life (HRQoL) in patients with chronic LBP. Additionally, we will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. We will enroll 434 patients with LBP presenting to primary care clinics serving rural communities (TidalHealth, Salisbury, MD). Eligible patients will provide informed consent and be randomized to either an educational control or risk-stratified telerehabilitation (low-risk, remote therapeutic monitoring; medium-risk, physical therapy telehealth visits; or high-risk, psychologically informed physical therapy telehealth visits). Primary effectiveness outcome is difference in change in LBP-related disability (Oswestry Disability Index) and in opioid use after 8 weeks of treatment.

NIH Project Information