Tailored Pain Guide (TPG) Study

University of Michigan

Status

Enrolling

Conditions

Chronic Lower Back Pain

Treatments

Behavioral: Standard PainGuide

Behavioral: Structured and tailored PainGuide

Study type

Interventional

Funder types

Other

Identifiers

NCT05843890

HUM00214375

Details and patient eligibility

About

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.

Full 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.

Enrollment

550 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.