Recruiting

Tailored Pain Guide

Sponsor:

University of Michigan

Code:

NCT05843890

Conditions

Chronic Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Structured and tailored PainGuide

Standard PainGuide

Study Details

Brief 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.

Conditions

Chronic Lower Back Pain

Study ID

NCT05843890

Start date

Aug 18, 2023

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Structured and tailored PainGuide

active comparator: Standard PainGuide

Interventions

Structured 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).

Standard 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).

Primary outcome measure

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Beth Banner

734-998-5837eledward@umich.edu

Sana Shaikh

734-763-5226skazi@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Beth Banner

734-998-5837eledward@umich.edu

Principal Investigator:

Daniel Clauw, MD

More Information

Sponsor

University of Michigan

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Online resources
  • Fitbit
  • Surveys

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-09.