Health Trials

Algorithm-informed Decision-making to Advance Pain Treatment

ConditionChronic Low-back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Michigan

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Algorithmically informed randomization (taking into account phenotypes)
  • Physical Therapy (PT) and Exercise
  • Cognitive-Behavioral Therapy for Pain (PRISM-CBT)
  • mHealth Acupressure Self-Management:
  • Duloxetine

Treatment groups

500 Participants
are divided into 28 treatment groups

28

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Michigan

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov