Digital intervention for managing chronic lower back pain
Tailored Pain Guide (TPG) Study
This study is testing if a personalized online program can help people with chronic lower back pain manage their pain better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05843890 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of a tailored digital self-management program, PainGuide, in improving outcomes for individuals suffering from chronic lower back pain. Participants will engage with structured online resources and surveys to assess changes in their pain interference levels. The study aims to determine if personalized digital interventions can lead to significant improvements in managing chronic pain. An amendment has been approved to increase enrollment and update recruitment procedures.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing chronic lower back pain for at least six months with significant pain interference.
Not a fit: Patients with cancer-related pain, autoimmune diseases, or those unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with effective digital tools to better manage their chronic lower back pain.
How similar studies have performed: Other studies have shown promise in using digital interventions for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Clauw, MD — University of Michigan
- Study coordinator: Beth Banner
- Email: eledward@umich.edu
- Phone: 734-998-5837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.