Clinical trial NCT06471920: Improving Health for Patients With Chronic LBP in Rural Communities Through Telerehabilitation
Official title: ARBOR Telehealth: Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Improved Access to Telerehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: chronic low back pain
physical therapy
Telehealth
telerehabilitation
rural
opioid
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Tidalhealth, Inc.
name: Medstar Health Research Institute
name: Maryland Rural Health Association
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-06-24
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic randomized clinical trial used a Type I Hybrid effectiveness-implementation design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Oswestry Disability Index
timeFrame: Change from baseline to 12 weeks after treatment initiation
Secondary outcomes:
measure: Participants with Opioid Use
timeFrame: Post treatment initiation 12 weeks
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Gender
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Age Group
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function by Baseline Opioid Use
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in PROMIS Preference Score (PROPr)
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in PROMIS Preference Score (PROPr) by Gender
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in PROMIS Preference Score (PROPr) by Age Group
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Change in PROMIS Preference Score (PROPr) by Baseline Opioid Use
timeFrame: Change from baseline to 26- and 52-weeks after treatment initiation
measure: Percent of participants using non-opioid LBP-Related Healthcare Use
timeFrame: 26- and 52-weeks after treatment initiation
measure: Percent of participants using non-opioid LBP-Related Healthcare Use by Gender
timeFrame: 26- and 52-weeks after treatment initiation
measure: Percent of participants using non-opioid LBP-Related Healthcare Use by Age Group
timeFrame: 26- and 52-weeks after treatment initiation
measure: Percent of participants using non-opioid LBP-Related Healthcare Use by Baseline Opioid Use
timeFrame: 26- and 52-weeks after treatment initiation
Other outcomes:
measure: Percent of patients approached who accept participation
timeFrame: At Screening
measure: Percent of patients offered telerehabilitation
timeFrame: At screening
measure: Percent of intervention sessions completed
timeFrame: 12-weeks after treatment initiation
measure: Percent of core treatment components provided during intervention sessions
timeFrame: 12-weeks after treatment initiation
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Salisbury
country: United States
facility: Tidalhealth
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Richard L Skolasky, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: