Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

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.

Conditions

Chronic Low Back Pain

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Study Overview

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Study Details

Study overview

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.

Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

Condition
Chronic Low Back Pain
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 21287

Salt Lake City

Intermountain Healthcare, Salt Lake City, Utah, United States, 84111

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Richard L. Skolasky, Sc.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Kevin McLaughlin, D.P.T., PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

2030-05-01