Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03478007
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Innovative Design Labs
Information provided by (Responsible Party):
Kenton R. Kaufman, Ph.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Intervention Technology Device: Intervention Technology Plus Coaching Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
No Intervention: Usual Treatment
Usual standard of care (exercises)
Experimental: Intervention Technology Only
Exercises with technology alone
Device: 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

Experimental: Intervention Technology Plus Coaching
Exercises with technology plus coaching
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478007


Contacts
Layout table for location contacts
Contact: Stacy Loushin, BS 507-284-2262 loushin.stacy@mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Innovative Design Labs
Investigators
Layout table for investigator information
Principal Investigator: Kenton R Kaufman, Ph.D Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Kenton R. Kaufman, Ph.D., Professor of Biomedical Engineering, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03478007    
Other Study ID Numbers: 16-002177
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenton R. Kaufman, Ph.D., Mayo Clinic:
Exercise Compliance
Health Coaching
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations