NCT06821607 · Johns Hopkins University
Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)
(TeleBACK)
What this study is about
The investigators will conduct a forward-looking, randomly assigned, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP).
View original scientific description
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization. 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 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
Interventions
BEHAVIORAL
In-Clinic Physical Therapy
Patients in this group will receive all PT sessions in-clinic with a trained physical therapist. Treatment provided for this group will be consistent with evidence-based guidelines that recommend patient education, exercise instruction, manual therapy interventions, and psychosocial interventions. Specific interventions to be provided within each of these categories: Education, Exercise, Manual Therapy, and Psychosocial interventions. Components of the intervention will be determined by the treating therapist based on patients' symptoms, examination findings, and patients' preferences and goals.
BEHAVIORAL
Telehealth Physical Therapy (Telerehabilitation)
Those randomized to telerehabilitation will receive all PT care, including the initial evaluation and 7 follow-up sessions, via real-time video conferencing technology. Like the interventions provided to those receiving in-clinic PT, treatments provided in the telerehabilitation group will be consistent with evidence-based guidelines, adapted for delivery via real-time video visits. Consistent with the in-clinic group, specific interventions will be selected by the treating physical therapist based on patients' symptoms, examination findings, and preferences and goals. There will be an emphasis: Open-ended questions to allow patients to describe the participant's impairments and limitations; Review patient-reported measures of disability and pain intensity to help identify functional impairments; and Clinical examination of spinal movements and impairments in strength, flexibility, and joint mobility.
Primary outcome measures
Change in Oswestry Disability Index
Time frame: Change from baseline to 3 months after treatment initiation
LBP-related disability. The total score range is \[0, 100\] with higher values representing greater pain-related disability.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.
- At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
- Meets NIH Task Force2 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.
- Can speak and understand English or Spanish (Utah sites only).
Exclusion criteria
- 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.
- Knowingly pregnant
Where
- Baltimore, Maryland
- Salt Lake City, Utah
Collaborators
University of Utah, Intermountain Health Care, Inc., Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations