Recruiting

Telerehabilitation

Sponsor:

Johns Hopkins University

Code:

NCT06471920

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standardized Education

Telerehabilitation

Study Details

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.

Conditions

Chronic Low-back Pain

Study ID

NCT06471920

Start date

Jan 27, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

434 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standardized Education

Patients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment.

experimental: Telerehabilitation

Based on prior STarT Back Tool (SBTS) screening risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to psychological informed physical therapy (PIPT) telehealth visits (high-risk).

The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment.

Interventions

Standardized Education

Patients randomized to the standardized education group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest.

Telerehabilitation

Based on prior SBTS risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to PIPT telehealth visits (high-risk).

Primary outcome measure

  • Change in Oswestry Disability Index [ Time Frame: Change from baseline to 12 weeks after treatment initiation ]
  • Participants with Opioid Use [ Time Frame: Post treatment initiation 12 weeks ]

Central Contacts and Locations

Central contacts

Richard L Skolasky, Sc.D.

410-502-7975rskolas1@jhmi.edu

Kevin McLaughlin, D.P.T.

410-614-3234kevin.mclaughlin@jhmi.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Richard L Skolasky, ScD

410-502-7975rskolas1@jhmi.edu

Principal Investigator:

Richard L Skolasky, ScD

Tidalhealth

Recruiting

Salisbury, Maryland, United States, 21801

Contacts

Jill Stone, PT

410-543-7017jill.stone@tidalhealth.org

Robert Joyner, Ph.D.

410-543-7017Robert.joyner@tidalhealth.org

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-22.