RECRUITING

Improving Health for Patients With Chronic LBP in Rural Communities Through Telerehabilitation

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

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.

Official Title

ARBOR Telehealth: Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Improved Access to Telerehabilitation

Quick Facts

Study Start:2025-01-27
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06471920

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary care visit in the past 90 days with an LBP-related International Classification of Diseases (ICD-10) diagnosis.
  2. * Age 18 years or older.
  3. * At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.
  4. * Meets NIH Task Force 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.
  5. * Can speak and understand English.
  6. * Access to video-enabled device and Internet.
  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 School of Medicine

Study Locations (Sites)

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States
Tidalhealth
Salisbury, Maryland, 21801
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Richard L Skolasky, Sc.D., 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 Date2025-01-27
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • chronic low back pain
  • physical therapy
  • Telehealth
  • telerehabilitation
  • rural
  • opioid

Additional Relevant MeSH Terms

  • Chronic Low-back Pain