NCT05843890

Tailored Pain Guide (TPG) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lower Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	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).
BEHAVIORAL	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).

Timeline

• Start date: 2023-08-18
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-05-06
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States