Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients

Study Overview
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Brief Summary
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The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. The investigators hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.

Detailed Description
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Innovative Design Labs (IDL) proposes to develop and deploy a low-cost measurement system which tracks exercise compliance and enables remote health coaching for patients with low back pain. The system will consist of a series of small motion sensors built into a custom designed harness which connect wirelessly to the user's tablet or smartphone. A software application will guide the patient through the exercise routine while the sensor system monitors their motion, classifies exercise completion, and tracks their progress through the protocol. The results of the routine will be securely uploaded to caregivers where they can monitor progress, modify the patient's exercise prescription, and offer encouragement and coaching to continue the therapy. This research program aims to enable the long term treatment-tracking of patients with chronic low back pain.

Official Title
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Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Intervention Technology
* Device: Intervention Technology Plus Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion 18 years or older Diagnosis of chronic low back pain (> 3 months duration) Have a current prescription for at-home exercises for chronic low back pain Exclusion Patients with a high likelihood of being lost to follow-up or contact Patients with an inability to provide good data or follow commands Patients with an inability to do mild exercise Patients with a history of spine surgery that included instrumentation or hardware Patients who are taking opioid medication chronically without reasonable reduction in pain

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Treatment<br>Usual standard of care (exercises) | |
| Experimental: Intervention Technology Only<br>Exercises with technology alone | Device: Intervention Technology<br>* Subjects will perform their exercises using the provided monitoring device. They will be able to contact the investigators with questions regarding the use of the monitoring device, however, no encouragement or coaching will be provided<br>|
| Experimental: Intervention Technology Plus Coaching<br>Exercises with technology plus coaching | Device: Intervention Technology Plus Coaching<br>* Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Back Disability Related Quality of Life | Participants will fill out the Modified Oswestry Disability Index, a 10 section questionnaire with 6 possible answers within each section. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is possible and would indicate 100% disability. A score of 0-20% indicates minimal disability. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Pain | Participants will fill out the pain Numerical Rating Scale survey, a 4 question survey used to rate intensity of pain from a scale of 0 (no pain) to 10 (worst possible pain). Pain is categorized as mile (1-3), moderate (4-6) or severe (7-10). | Baseline and 8 weeks | 
| Degree of Compliance | Compliance collected through written diaries (control group) or electronically recorded compliance monitoring. Compliance will be defined on whether or not the subject completed the assigned exercises each day. | 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Compliance, Health Coaching