RecruitingNot ApplicableNCT05843890

Tailored Pain Guide (TPG) Study


Sponsor

University of Michigan

Enrollment

550 participants

Start Date

Aug 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Chronic lower back pain (cLBP) is one of the most prevalent and costly health problems worldwide, and its management increasingly relies on non-pharmacological approaches. The Tailored Pain Guide (TPG) study tests whether a personalized digital pain management tool — designed to guide patients through non-pharmacological pain strategies — can improve pain-related functioning for people with chronic low back pain. Adults with chronic low back pain (present for at least 6 months on more than half of days) who score at or above 60 on the PROMIS Pain Interference scale (indicating significant functional impact) are eligible. There is a non-pharmacological sub-study arm for patients currently on the waitlist for a non-pharmacological pain program. People with cancer-related pain, autoimmune disease, language or sensory barriers, or pregnancy are excluded. Personalized digital health tools represent a scalable way to extend pain care beyond clinic visits. By tailoring recommendations to each patient's specific situation and preferences, the TPG may produce better adherence and outcomes than generic advice — providing evidence to support wider adoption of digital therapeutics in pain management.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALStructured 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).

BEHAVIORALStandard 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).


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05843890


Related Trials