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Completed

NCT Number: NCT03478007

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

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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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Technology

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

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.

Primary outcomes

  1. Change in Back Disability Related Quality of Life

    Time frame: Baseline and 8 weeks

    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.

Secondary outcomes

  1. Change in Overall Pain

    Time frame: Baseline and 8 weeks

    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).

  2. Degree of Compliance

    Time frame: 4 and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Innovative Design Labs
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2018
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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