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

Mayo Clinic

Status: Completed

Conditions: Low Back Pain

Treatments: Device: Intervention Technology; Device: Intervention Technology Plus Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03478007

16-002177

R44AG055152-02A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 3 patient groups

Usual Treatment

No Intervention group

Description:

Usual standard of care (exercises)

Intervention Technology Only

Experimental group

Description:

Exercises with technology alone

Treatment:

Device: Intervention Technology

Intervention Technology Plus Coaching

Experimental group

Description:

Exercises with technology plus coaching

Treatment:

Device: Intervention Technology Plus Coaching