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

NCT03478007 | Completed

• 2 other identifiers: 16-002177R44AG055152-02A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Exercise Compliance; Health Coaching

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Overall Pain

  Baseline and 8 weeks

• Degree of Compliance

  4 and 8 weeks

Study Arms (3)

Usual Treatment

NO INTERVENTION

Usual standard of care (exercises)

Intervention Technology Only

EXPERIMENTAL

Exercises with technology alone

Device: Intervention Technology

Intervention Technology Plus Coaching

EXPERIMENTAL

Exercises with technology plus coaching

Device: Intervention Technology Plus Coaching

Interventions

Intervention Technology DEVICE

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 Only

Intervention Technology Plus Coaching DEVICE

Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.

Intervention Technology Plus Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Innovative Design Labs: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenton R Kaufman, Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Engineering, College of Medicine

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: August 21, 2019
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)