Tailored Pain Guide (TPG) Study

Last updated: March 26, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Structured and tailored PainGuide

Standard PainGuide

Clinical Study ID

NCT05843890
HUM00214375
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 backpain 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 PainInterference.

  • Non-Pharma Sub-study:

  1. Must be referred and currently on the waitlist for the NPP at the Back & PainCenter (BPC)

Exclusion

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 studyparticipation as determined by the site principal investigators.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Structured and tailored PainGuide
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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