BMJ open · 2026
TeleBACK clinical trial: comparing the effectiveness of telerehabilitation and in-clinic physical therapy for patients with chronic low back pain - protocol for a multicentre, pragmatic, individually randomised group treatment trial.
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McLaughlin Kevin H, Fritz Julie M, Minick Kate I, Hunter Stephen, Moffit Steven, Schneider Matthew, Lane Elizabeth, Ford Isaac, Romero Adrianna, Colantuoni Elizabeth, Wegener Stephen T, Skolasky Richard L
Аннотация
INTRODUCTION: Chronic low back pain (LBP) is a leading cause of disability and healthcare spending in the USA. While physical therapy (PT) has been shown to improve disability and pain as well as decrease the cost of care associated with LBP, only a small portion (<15%) of eligible patients with LBP ever attend PT. These low utilisation rates are likely influenced by logistical barriers to attending visits (eg, transportation, missed work time). Patients with chronic pain may also struggle to attend frequent clinic visits because of their symptoms. Telerehabilitation, which expanded substantially during the COVID-19 pandemic, can potentially address these barriers by allowing patients to receive PT remotely. However, the effectiveness of telerehabilitation for chronic LBP is unclear.
METHODS AND ANALYSIS: This multicentre, pragmatic, individually randomised group treatment, non-inferiority clinical trial will compare synchronous, video-based telerehabilitation with standard in-clinic PT in 1000 adults with chronic LBP (≥3 months duration) receiving primary or specialty care across three healthcare systems in Maryland and Utah. Participants will be randomised 1:1 to receive eight PT sessions over 8 weeks via either video conferencing or in-clinic visits and will be assessed at baseline, 3 months, 6 months and 1 year. The primary outcome is 3-month change in LBP-related disability as measured by the Oswestry Disability Index using a non-inferiority margin of 6 points, based on the minimal clinically important difference for this measure. Secondary outcomes include changes in pain intensity, pain interference and physical function, and LBP-related opioid and healthcare utilisation. Exploratory measures include treatment satisfaction and therapeutic alliance.
ETHICS AND DISSEMINATION: This study was approved by the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this study. Once the study is complete, study data will be shared in compliance with guidelines from the Patient-Centered Outcomes Research Institute.
TRIAL REGISTRATION NUMBER: NCT06821607.
METHODS AND ANALYSIS: This multicentre, pragmatic, individually randomised group treatment, non-inferiority clinical trial will compare synchronous, video-based telerehabilitation with standard in-clinic PT in 1000 adults with chronic LBP (≥3 months duration) receiving primary or specialty care across three healthcare systems in Maryland and Utah. Participants will be randomised 1:1 to receive eight PT sessions over 8 weeks via either video conferencing or in-clinic visits and will be assessed at baseline, 3 months, 6 months and 1 year. The primary outcome is 3-month change in LBP-related disability as measured by the Oswestry Disability Index using a non-inferiority margin of 6 points, based on the minimal clinically important difference for this measure. Secondary outcomes include changes in pain intensity, pain interference and physical function, and LBP-related opioid and healthcare utilisation. Exploratory measures include treatment satisfaction and therapeutic alliance.
ETHICS AND DISSEMINATION: This study was approved by the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this study. Once the study is complete, study data will be shared in compliance with guidelines from the Patient-Centered Outcomes Research Institute.
TRIAL REGISTRATION NUMBER: NCT06821607.