NCT05843890NARecruiting

Tailored Pain Guide (TPG) Study

University of Michigan

Start Date

8/18/2023

Completion Date

2/1/2028

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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 English * Visual or hearing difficulties * Pregnancy or breastfeeding * Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Interventions

BEHAVIORAL

Structured and tailored PainGuide

BEHAVIORAL

Standard PainGuide

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Conditions

Chronic Lower Back Pain

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States