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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