← 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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26- and 52-weeks after treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26- and 52-weeks after treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26- and 52-weeks after treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Oswestry Disability Index

Opioid Use

Secondary study objectives

Change in PROMIS Preference Score (PROPr)

Change in PROMIS Preference Score (PROPr) by Age Group

Change in PROMIS Preference Score (PROPr) by Baseline Opioid Use

+9 more

Other study objectives

Percent of core treatment components provided during intervention sessions

Percent of intervention sessions completed

Percent of patients approached who accept participation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 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 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

0 / 5Eligibility criteria met