Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain

Study Overview
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Brief Summary
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The prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include comprehensive metrics to confirm whether participants actually participated in the exercises prescribed. In this pilot study, the investigators hope to determine whether proxies of compliance with a daily, self-directed rehabilitation program for discogenic low back pain are correlated with participant-reported improvements in pain and function. The feasibility of a mobile interface designed to help patients with chronic low back pain track the daily management of their conditions will also be evaluated.

Official Title
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Personalized Back Rx Exercise Program With Coaching, Social Support, and Sensor-assisted Assessments as a Treatment for Discogenic Low Back Pain: A Prospective Pilot Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Back Rx program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low back pain with predominantly axial symptoms (axial pain > leg pain) that are exacerbated with sitting and alleviated with walking Persistence of symptoms for at least 3 months Lumbar intervertebral disc pathology evident on magnetic resonance imaging 18 to 65 years old Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up) English speaking Exclusion Criteria: Concurrent pathology that may contribute to patients' axial low back symptoms (e.g., spondylolysis, spondylolisthesis, facet arthropathy) Severe lumbar disc degeneration prior to beginning Back Rx exercise program History of lumbar spine surgery or other interventions prior to beginning Back Rx exercise program History of trauma Cases involving workers' compensation or other legal claims Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back Rx program<br>Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos. | Other: Back Rx program<br>* The Back Rx program can be viewed via a smartphone app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability. | Up to 12 months post-program start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with app/program | Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed | Up to 12 months post-program start | 
| Satisfaction with program | Participants will be asked whether they would recommend the app to a friend. | Up to 12 months post-program start | 
| Medication utilization | Usage of medications will be documented | Up to 3 months post-program start | 
| Pain score | Pain will be assessed via the visual analog scale | Up to 12 months post-program start |