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Recruiting NCT07731750

NCT07731750 Algorithm-informed Decision-making to Advance Pain Treatment

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Clinical Trial Summary
NCT ID NCT07731750
Status Recruiting
Phase —
Sponsor University of Michigan
Condition Chronic Low-back Pain
Study Type INTERVENTIONAL
Enrollment 500 participants
Start Date 2026-07-23
Primary Completion 2030-02

Eligibility & Interventions

Sex All sexes
Min Age 25 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Algorithmically informed randomization (taking into account phenotypes)Physical Therapy (PT) and ExerciseCognitive-Behavioral Therapy for Pain (PRISM-CBT)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 500 participants in total. It began in 2026-07-23 with a primary completion date of 2030-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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 (spine infection) or spine tumor * History of an autoimmune disorder such as ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus * History of cauda equina syndrome or spinal radiculopathy * Diagnosis of schizophrenia or schizoaffective diagnosis * Diagnosis of any vertebral fracture in the last 6 months * Osteoporosis requiring treatment (vitamin D and calcium supplements are acceptable) * Cancer * History of any bone-related cancer or cancer that metastasized to the bone * Currently in treatment for cancer or plan to start cancer treatment in the next 12 months * History of any cancer treatment in the last 24 months * Life expectancy is less than 2 years * Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial. * Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or recent suicide attempts

Contact & Investigator

Central Contact

Beth Banner

✉ eledward@med.umich.edu

📞 734-763-5226

Principal Investigator

Afton Hassett, PsyD

PRINCIPAL INVESTIGATOR

University of Michigan

Frequently Asked Questions

Who can join the NCT07731750 clinical trial?

This trial is open to participants of all sexes, aged 25 Years or older, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07731750 currently recruiting?

Yes, NCT07731750 is actively recruiting participants. Contact the research team at eledward@med.umich.edu for enrollment information.

Where is the NCT07731750 trial being conducted?

This trial is being conducted at Ann Arbor, United States.

Who is sponsoring the NCT07731750 clinical trial?

NCT07731750 is sponsored by University of Michigan. The principal investigator is Afton Hassett, PsyD at University of Michigan. The trial plans to enroll 500 participants.

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