← Back to Search

Behavioral Intervention

Telerehabilitation for Lower Back Pain (ARBOR-Th Trial)

N/A
Waitlist Available
Led By Richard L Skolasky, Sc.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets NIH Task Force2 definition of chronic LBP based on specific questions
Age 18 years or older
Must not have
Recent history (last 6 months) of lumbar spine surgery
Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening
Awards & highlights

Summary

"This trial aims to compare the effectiveness of a new digital physical therapy approach to the standard educational control for patients with chronic low back pain. The new approach, called telerehabilitation, could potentially improve

Who is the study for?
This trial is for people with chronic lower back pain (LBP) who live in rural areas and have trouble accessing physical therapy due to provider availability, transportation issues, or work conflicts. Participants should be willing to engage in telerehabilitation.
What is being tested?
The study tests the effectiveness of telerehabilitation—a way to do physical therapy over the internet—against standard educational materials for managing chronic LBP. It will also see if matching patients with specific types of telehealth visits based on their psychological risk improves outcomes.
What are the potential side effects?
Since this trial involves non-invasive interventions like online physical therapy sessions and education control, side effects are minimal but may include discomfort from new exercises or frustration with technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic lower back pain.
Select...
I am 18 years old or older.
Select...
I experience moderate to severe pain and disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had lumbar spine surgery in the last 6 months.
Select...
I have a severe movement disorder or a serious mental health condition like schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Oswestry Disability Index
Opioid Use
Secondary outcome measures
Change in PROMIS Preference Score (PROPr)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Percent of participants using non-opioid LBP-Related Healthcare Use
Other outcome measures
Change in Heterogeneity of Treatment Effect
Percent of core treatment components provided during intervention sessions
Percent of intervention sessions completed
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TelerehabilitationExperimental Treatment1 Intervention
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 SBST 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 II: Educational ControlActive Control1 Intervention
Patients randomized to the educational control 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telerehabilitation
2017
N/A
~1120

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,842,631 Total Patients Enrolled
Tidalhealth, Inc.UNKNOWN
Maryland Rural Health AssociationUNKNOWN
~289 spots leftby Apr 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top