An interventional study of Standardized Education and Telerehabilitation in Chronic Low-back Pain, sponsored by Johns Hopkins University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
The investigators will conduct a prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed 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, the investigators 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. The investigators 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 web-based standardized education or risk-informed telerehabilitation (physical therapy telehealth visits, or 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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients 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. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment.
Behavioral: Standardized Education
Based on prior STarT Back Tool (SBTS) screening 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 psychological informed physical therapy (PIPT) telehealth visits (high-risk). The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment.
Behavioral: Telerehabilitation
Patients 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.
Based 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.
Time frame: Change from baseline to 12 weeks after treatment initiation
Participants with Opioid Use
self-reported and/or Electronic Health Record (EHR) documented opioid use
Time frame: Post treatment initiation 12 weeks
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.
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Biological Sex
Physical function. The total score range is \[0, 100\] with higher scores indicating better physical function.
Time frame: Change from baseline to 26- 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.
Time frame: Change from baseline to 26- 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.
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr)
Total score range is \[0, 100\] with higher scores indicating better outcome.
Time frame: Change from baseline to 26- and 52-weeks after treatment initiation
Change in PROMIS Preference Score (PROPr) by Biological Sex
Total score range is \[0, 100\] with higher scores indicating better outcome.
Time frame: Change from baseline to 26- 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.
Time frame: Change from baseline to 26- 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.
Time frame: Change from baseline to 26- 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)
Time frame: 26- and 52-weeks after treatment initiation
Percent of participants using non-opioid LBP-Related Healthcare Use by Biological Sex
Non-opioid LBP-related healthcare use (e.g., physician office visit, imaging, surgery)
Time frame: 26- 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)
Time frame: 26- 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)
Time frame: 26- and 52-weeks after treatment initiation
Percent of patients approached who accept participation
Implementation - Acceptability as assessed by percent of patients approached who accept participant
Time frame: At Screening
Percent of patients offered telerehabilitation
Implementation - Adoption as assessed by percent of patients offered tele-rehabilitation
Time frame: At screening
Percent of intervention sessions completed
Implementation - Feasibility as assessed by percent of intervention sessions completed
Time frame: 12-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
Time frame: 12-weeks after treatment initiation
Plan to share: Yes — The Research Team at the Johns Hopkins University and TidalHealth (sub-award) for the proposal titled "Improving Function and Reducing Opioid Use for Patients with Chronic Low Back Pain in Rural Communities through Improved Access to Physical Therapy using Telerehabilitation" (RFA-NR-23-001) agree to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality, and data sharing plans to be developed by the Helping to End Addiction Long-term (HEAL) Consortium. The following document exists to reflect best practices for data acquisition, management, stewardship, and dissemination that are consistent with the HEAL Initiative Public Access and Data Sharing Policy.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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