Not Yet RecruitingNot Applicable

Algorithm-informed Decision-making to Advance Pain Treatment

United States500 participantsStarted 2026-07

Plain-language summary

Researchers are exploring how certain personal factors, such as symptoms, health history, and lifestyle, may help predict which treatments will work best for someone. The purpose of this study is to evaluate how well a study algorithm chooses the best treatments for a patient when considering their unique pain characteristics.

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet the definition of Chronic Low Back Pain (cLBP) described in the NIH Task Force Report on Research Standards for cLBP, i.e., low back pain present at least six months, and present more than half of those days.2 * Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is 50. Participants must be 1 standard deviation (SD) above the population mean (\>=60) for inclusion. * Individuals must be willing and eligible to receive at least three of the four proposed interventions. * Able to stand for at least 10 minutes Exclusion Criteria: * Red flags suggesting the presence of an identifiable cause of low back pain, including fever, weight loss, initiation of pain following major trauma, immunosuppression, IV drug use, recent bacterial infection, severe or persistent sensory or motor involvement of bowel, bladder, or lower extremity. * Unable to read, write of speak fluent English * Visual or hearing difficulties that would preclude participation * Active uncontrolled drug/alcohol addiction * Individuals receiving new disability or compensation or involved in litigation in the past 12 months. * Pregnancy or breastfeeding * Individuals on high doses of opioids (over 100 Oral Morphine Equivalents \[OME\] per day). * Upcoming scheduled back surgery, back surgery within the last year, or more than one back surgery in the past. * History of discitis osteomyelitis (sp…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses an algorithm to help guide pain treatment decisions — can you explain what that means in practice, and whether my own treatment history and data would actually shape the recommendations I receive?
2Since this trial isn't recruiting yet, how long might it be before it opens, and is there a standard treatment path I should be pursuing in the meantime for my chronic low back pain?
3The trial measures changes in a score called PEG, which tracks pain, enjoyment of life, and general activity — do you think those are the right outcomes to focus on for my situation, or are there other things I'd want to see improve that this study might not capture?
4Because this trial is listed as Phase NA, what does that tell us about how much is already known regarding the safety and effectiveness of this algorithm-guided approach, and how does that uncertainty factor into whether it might be right for me?
5Are there existing treatments or guidelines for chronic low back pain that you'd recommend I try first, and how would starting those now affect my eligibility if this trial does open up in the future?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain, Enjoyment and General Activity (PEG) scores

Timeframe: T2 (approximately week 6) - T3 (approximately week 15)

Trial details

NCT IDNCT07731750

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-02

Contact for this trial

Beth Banner

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

View on ClinicalTrials.gov More Chronic Low-back Pain trials