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Algorithm-informed Decision-making to Advance Pain Treatment

RecruitingNot applicableNCT07731750
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
Interventions
  • Device: Algorithmically informed randomization (taking into account phenotypes)
  • Behavioral: Physical Therapy (PT) and Exercise
  • Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT)
  • Behavioral: mHealth Acupressure Self-Management:
  • Drug: Duloxetine
Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date
2026-07-23
Primary completion
2030-02
Sex
All
Age range
from 25 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 de…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07731750