Tailored Pain Guide (TPG) Study
University of Michigan
Summary
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants. The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.
Description
There was an amendment approved by the University of Michigan Medical School Institutional Review Board (AME00158411). This amendment included the following: increased enrollment numbers, updated recruitment procedures including the Non-Pharma Program (NPP) Sub-Study, as well as changes in time frames.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Chronic Lower Back pain (cLBP) defined by the National Institutes of Health (NIH) Task Force Report on Research Standards for Chronic Low Back Pain, (i.e., low back pain present at least six months, and present more than half of those days.) * Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference. * Non-Pharma Sub-study: 1. Must be referred and currently on the waitlist for the NPP at the Back \& Pain Center (BPC) Exclusion Criteria: * Current cancer related pain * Diagnosis of autoimmune disease * Unable to speak, write or read Eng…
Interventions
- BehavioralStructured and tailored PainGuide
Participants will receive specific instruction to complete one module a week over the first 4 weeks. Participants will then receive tailored messaging using scores from the assessments completed during T1(baseline visit) from the PROMIS 29+2. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
- BehavioralStandard PainGuide
Participants in the control group will not receive any messaging once enrolled. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Location
- University of MichiganAnn Arbor, Michigan