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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-21

Study Completion Date

2021-12-06

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.

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Treatment

Usual standard of care (exercises)

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Technology Only

Exercises with technology alone

Group Type EXPERIMENTAL

Intervention Technology

Intervention Type DEVICE

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

Intervention Technology Plus Coaching

Exercises with technology plus coaching

Group Type EXPERIMENTAL

Intervention Technology Plus Coaching

Intervention Type DEVICE

Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.

Interventions

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Intervention Technology

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

Intervention Type DEVICE

Intervention Technology Plus Coaching

Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No