Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Telerehabilitation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

Qualifiers

Primary care visit in the past 90 days with an LBP-related International Classification of Diseases (ICD-10) diagnosis.

Age 18 years or older.

At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4/10 points.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Standardized Education
  • Telerehabilitation

Treatment groups

434 Participants
are divided into 2 treatment groups

Locations

2
Johns Hopkins University School of Medicine21287, BaltimoreMaryland, United States
Tidalhealth21801, SalisburyMaryland, United States

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

TidalHealth, Inc.

Collaborator

Medstar Health Research Institute

Collaborator

Maryland Rural Health Association

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator