Actively Recruiting
Tailored Pain Guide (TPG) Study for Chronic Lower Back Pain Using Digital Behavioral Interventions
Led by University of Michigan · Updated on 2026-03-09
550
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how changing individual behaviors might affect chronic lower back pain using an electronic self-management website called PainGuide. The study aims to understand whether tailored digital support combined with PainGuide leads to greater improvements in pain interference, compared to standard PainGuide use. This research is sponsored by the University of Michigan and includes an amendment that expanded enrollment and updated recruitment procedures. Participants are randomly assigned to one of two groups: a structured and tailored PainGuide group or a standard PainGuide group. Those in the tailored group receive specific instructions to complete one module weekly for the first four weeks, followed by personalized messages based on assessments from the PROMIS 29+2 survey at baseline. Both groups wear a Fitbit device linked to PainGuide to collect daily movement data. The initial participant group completes surveys for 24 weeks, while those in the Non-Pharma Program (NPP) Sub-Study complete surveys for 52 weeks. During the study, participants complete surveys measuring pain interference, pain intensity, cognitive function, physical function, anxiety, depression, fatigue, sleep disturbance, and social participation using the PROMIS 29 tool at baseline and at follow-up weeks 24 or 52 depending on the group. Movement data from Fitbit devices is also collected. The main outcome is the change in PROMIS Pain Interference scores from baseline to week 24. This study continues until February 2028 and monitors participant progress through digital tools and regular assessments.
CONDITIONS
Brief Title
Tailored Pain Guide (TPG) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Chronic lower back pain lasting at least six months and present more than half of those days
- PROMIS Pain Interference score of 60 or greater
- For Non-Pharma Sub-study participants: currently referred and on the waitlist for the Non-Pharma Program at the Back & Pain Center
You will not qualify if you...
- 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 deemed unsuitable for study participation by the site principal investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks or 52 weeks depending on group
Participants receive behavioral interventions including completing one module a week for 4 weeks and tailored messaging based on baseline assessments. Some participants complete surveys for 24 weeks, while others in the Non-Pharma Program Sub-Study complete surveys for 52 weeks. All participants use a Fitbit device to capture daily movement data.
Regular survey completions; Fitbit data collected daily
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
B
Beth Banner
S
Sana Shaikh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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