Low Back Pain
Conditions
Keywords
Exercise Compliance, Health Coaching
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.
Interventions
DEVICEIntervention 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
DEVICEIntervention 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.
Sponsors
Innovative Design Labs
National Institute on Aging (NIA)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed