Algorithm-informed Decision-making to Advance Pain Treatment

NCT ID
NCT07731750
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
University of Michigan

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 500 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Michigan, United States: 1

Sample of listed locations

  • University of Michigan — Ann Arbor, Michigan, 48109, United States — Site recruitment status not specified in the registry data

Study details

Start date
July 23, 2026
Primary completion date
February 1, 2030
First posted
July 28, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07731750
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07731750 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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