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

NCT ID: NCT06471920

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2028-08-31

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.

Detailed Description

Chronic low back pain (LBP) imposes tremendous burden on affected individuals, healthcare systems, and society. LBP has been identified as the most common cause of disability globally and in the United States (US). LBP is also the largest driver of US healthcare spending ($135 billion in 2016) and the most common diagnoses associated with opioid prescription and consumption. For patients with chronic LBP, physical therapy has been shown to be a cost-effective method for improving pain and disability. In addition, physical therapy has been shown to decrease the risk of advanced imaging, injections, surgery, and opioid use in patients with chronic LBP.

Despite available evidence in support, only 7-13% of patients with LBP, including those with chronic LBP, go on to receive physical therapy services, with patients reporting barriers accessing physical therapy, such as transportation, provider availability and missed work time. Access is especially limited in rural communities where there are approximately 40% fewer physical therapists available per capita compared to metropolitan regions. In addition, patients living in rural communities likely need to travel longer distances to receive physical therapy, requiring additional missed work time and transportation costs. This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas. Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US. Telehealth has rapidly expanded during the COVID-19 pandemic. This includes policy changes that have allowed physical therapists to begin providing care remotely, also referred to as telerehabilitation. Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients.

The investigators will conduct a prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life (HRQoL) in patients with chronic LBP. Additionally, the investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 434 patients with LBP presenting to primary care clinics serving rural communities (TidalHealth, Salisbury, MD). Eligible patients will provide informed consent and be randomized to either web-based standardized education or risk-informed telerehabilitation (physical therapy telehealth visits, or informed physical therapy telehealth visits). Primary effectiveness outcome is difference in change in LBP-related disability (Oswestry Disability Index) and in opioid use after 8 weeks of treatment.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standardized Education

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: 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).

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tidalhealth, Inc.

UNKNOWN

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Maryland Rural Health Association

UNKNOWN

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Skolasky, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Tidalhealth

Salisbury, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard L Skolasky, Sc.D.

Role: CONTACT

rskolas1@jhmi.edu

410-502-7975

Kevin McLaughlin, D.P.T.

Role: CONTACT

kevin.mclaughlin@jhmi.edu

410-614-3234

Facility Contacts

Richard L Skolasky, ScD

Role: primary

rskolas1@jhmi.edu

410-502-7975

Jill Stone, PT

Role: primary

jill.stone@tidalhealth.org

410-543-7017

Robert Joyner, Ph.D.

Role: backup

Robert.joyner@tidalhealth.org

410-543-7017

References

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.

Reference Type: DERIVED

PMID: 40499966 (View on PubMed)

Other Identifiers

UG3AR083838

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00437961

Identifier Type: -

Identifier Source: org_study_id