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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: Intervention Technology Plus Coaching; Device: Intervention Technology

• Registration Number: NCT03478007
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Study Start: 2019-08-21
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Technology Plus Coaching	Intervention Technology Plus Coaching	Exercises with technology plus coaching
Intervention Technology Only	Intervention Technology	Exercises with technology alone

Primary Outcome Measures

Name	Time	Method
Change in Back Disability Related Quality of Life	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

Name	Time	Method
Change in Overall Pain	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).
Degree of Compliance	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States