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

NCT06471920 | Recruiting DMC

• 2 other identifiers: IRB00437961UG3AR083838
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Oswestry Disability Index

  LBP-related disability. The total score range is \[0, 100\] with higher values representing greater pain-related disability.

  Change from baseline to 12 weeks after treatment initiation

• Participants with Opioid Use

  self-reported and/or Electronic Health Record (EHR) documented opioid use

  Post treatment initiation 12 weeks

Secondary Outcomes (12)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function

  Change from baseline to 26- and 52-weeks after treatment initiation

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Gender

  Change from baseline to 26- and 52-weeks after treatment initiation

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group

  Change from baseline to 26- and 52-weeks after treatment initiation

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Baseline Opioid Use

  Change from baseline to 26- and 52-weeks after treatment initiation

• Change in PROMIS Preference Score (PROPr)

  Change from baseline to 26- and 52-weeks after treatment initiation

Other Outcomes (4)

• Percent of patients approached who accept participation

  At Screening

• Percent of patients offered telerehabilitation

  At screening

• Percent of intervention sessions completed

  12-weeks after treatment initiation

Study Arms (2)

Standardized Education

ACTIVE COMPARATOR

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.

Behavioral: Standardized Education

Telerehabilitation

EXPERIMENTAL

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.

Behavioral: Telerehabilitation

Interventions

Standardized Education BEHAVIORAL

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.

Standardized Education

Telerehabilitation BEHAVIORAL

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).

Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• TidalHealth, Inc.: collaborator
• Medstar Health Research Institute: collaborator
• Maryland Rural Health Association: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Tidalhealth

Salisbury, Maryland, 21801, United States

RECRUITING

Related Publications (1)

• Skolasky RL, Colantuoni E, Wegener ST, Ali KJ, McLaughlin KH. ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities - protocol of a pragmatic, individually randomised group treatment trial. BMJ Open. 2025 Jun 10;15(6):e102773. doi: 10.1136/bmjopen-2025-102773.

  PMID: 40499966 DERIVED

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Richard L Skolasky, Sc.D.

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic randomized clinical trial used a Type I Hybrid effectiveness-implementation design

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after final dataset is closed, curated, and uploaded to the data sharing platform. Data will be available in perpetuity.
• Access Criteria: Data will be accessible on a closed-access basis. Researchers will have to request access and have this request be approved.

Locations

US (2)