Back to search results

Algorithm-informed Decision-making for Chronic Low-back Pain Treatment

This study is looking for 500 participants with chronic low-back pain (pain lasting at least six months) to see if a special computer program (algorithm) can help choose the best treatment for each person. Researchers want to understand how your unique health information, like symptoms and medical history, can predict which treatments will work best for you. You might receive Physical Therapy and Exercise, Cognitive-Behavioral Therapy for Pain (PRISM-CBT), mHealth Acupressure Self-Management, or Duloxetine (an FDA-approved medication for chronic pain). The main goal is to see how much your pain, enjoyment of life, and daily activities improve after about 6 to 15 weeks of treatment.

Study design
This is an interventional study involving 500 participants. An algorithm will help decide which treatment you receive, based on your personal health information.
What's involved
You would receive one of four interventions: 10 in-person physical therapy sessions over 8 weeks, daily Duloxetine medication for 8 weeks, daily self-acupressure for 8 weeks, or 8 weekly virtual CBT sessions with coaching.
Compensation
Not stated in the trial record.
Follow-up
Your pain, enjoyment, and general activity will be measured after about 6 weeks and again at about 15 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07731750

Algorithm-informed Decision-making to Advance Pain Treatment

Not Yet Recruiting
NAAges 25+InterventionalHealth services
University of Michigan
~500 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Algorithmically informed randomization (taking into account phenotypes)Physical Therapy (PT) and ExerciseCognitive-Behavioral Therapy for Pain (PRISM-CBT)mHealth Acupressure Self-Management:Duloxetine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain, Enjoyment and General Activity (PEG) scores
Measured over T2 (approximately week 6) - T3 (approximately week 15)

Conditions

Chronic Low-back Pain

Explore related trials

Chronic low back pain

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Afton Hassett, PsyD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Daniel Clauw, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Beth Banner
[email protected]
734-763-5226
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Pain, Enjoyment and General Activity (PEG) scoresT2 (approximately week 6) - T3 (approximately week 15)

    The PEG is a three-item survey measure used to assess pain by asking for ratings of Pain intensity, Enjoyment of life, and General activity on a scale of 0-10 over the past week. The final score is the average of the three ratings, with higher scores indicating greater pain severity or interference.