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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Technology
Intervention Technology Plus Coaching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise Compliance, Health Coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Treatment

Intervention Technology Only

Intervention Technology Plus Coaching

Arm Description

Usual standard of care (exercises)

Exercises with technology alone

Exercises with technology plus coaching

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
March 20, 2018
Last Updated
April 7, 2022
Sponsor
Mayo Clinic
Collaborators
Innovative Design Labs, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03478007
Brief Title
Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
Official Title
Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Innovative Design Labs, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Exercise Compliance, Health Coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Treatment
Arm Type
No Intervention
Arm Description
Usual standard of care (exercises)
Arm Title
Intervention Technology Only
Arm Type
Experimental
Arm Description
Exercises with technology alone
Arm Title
Intervention Technology Plus Coaching
Arm Type
Experimental
Arm Description
Exercises with technology plus coaching
Intervention Type
Device
Intervention Name(s)
Intervention Technology
Intervention Description
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 Name(s)
Intervention Technology Plus Coaching
Intervention Description
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 Measure Information:
Title
Change in Back Disability Related Quality of Life
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Overall Pain
Description
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).
Time Frame
Baseline and 8 weeks
Title
Degree of Compliance
Description
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.
Time Frame
4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenton R Kaufman, Ph.D
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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