Algorithm-informed care to find the best pain treatment for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with chronic low back pain are assigned to one or more treatments chosen by a phenotype-informed algorithm, with options to continue, switch, or add treatments across eight weeks. Interventions include physical therapy with exercise, duloxetine, an mHealth acupressure program, and PRISM-CBT with weekly coaching. The study compares initial treatment assignments based on the algorithm to other possibilities to see if the algorithm can identify the most effective options for each participant without revealing assignments during the trial. Outcomes focus on whether the initial algorithm-based choices lead to better pain-related function and overall relief. Location is University of Michigan, with NIAMS collaboration, and eligibility requires chronic, functionally impactful low back pain and ability to participate in most interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Afton Hassett, PsyD — University of Michigan
• Study coordinator: Beth Banner
• Email: eledward@med.umich.edu
• Phone: 734-763-5226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.