NCT06471920 Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Telerehabilitation
| NCT ID | NCT06471920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 434 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 434 participants in total. It began in 2025-01-27 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. * Can speak and understand English. * Access to video-enabled device and Internet. 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.
Contact & Investigator
Richard L Skolasky, Sc.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06471920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06471920 currently recruiting?
Yes, NCT06471920 is actively recruiting participants. Contact the research team at rskolas1@jhmi.edu for enrollment information.
Where is the NCT06471920 trial being conducted?
This trial is being conducted at Baltimore, United States, Salisbury, United States.
Who is sponsoring the NCT06471920 clinical trial?
NCT06471920 is sponsored by Johns Hopkins University. The principal investigator is Richard L Skolasky, Sc.D. at Johns Hopkins School of Medicine. The trial plans to enroll 434 participants.