RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2030-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06821607

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.
  2. * At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
  3. * 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.
  4. * Can speak and understand English or Spanish (Utah sites only).
  1. * Recent history (last 6 months) of lumbar spine surgery.
  2. * Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).
  3. * Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
  4. * Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.
  5. * Knowingly pregnant

Contacts and Locations

Study Contact

Richard L Skolasky, Sc.D.
CONTACT
410-502-7975
rskolas1@jhmi.edu
Kevin McLaughlin, D.P.T.
CONTACT
410-614-3234
kevin.mclaughlin@jhmi.edu

Principal Investigator

Richard L. Skolasky, Sc.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Kevin McLaughlin, D.P.T.
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States
Intermountain Healthcare
Salt Lake City, Utah, 84111
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2030-05-01

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2030-05-01

Terms related to this study

Keywords Provided by Researchers

  • chronic low back pain
  • physical therapy
  • telehealth
  • telerehabilitation

Additional Relevant MeSH Terms

  • Chronic Low Back Pain