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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478007
• Other study ID #: 16-002177
• Secondary ID: R44AG055152-02A1
• Status: Completed
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: December 6, 2021

Study information

• Verified date: April 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Innovative Design Labs, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 8 weeks
Secondary	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).	Baseline and 8 weeks
Secondary	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.	4 and 8 weeks

External Links

•   Mayo Clinic Clinical Trials