Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
University of Michigan
Summary
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.
Description
During the treatment stages participants may be placed into the following interventions: 1. Physical Therapy \& Exercise -10, standardized sessions over 8 weeks delivered individually and in-person by a physical therapist 2. Duloxetine - FDA approved for musculoskeletal pain, self-administered SNRI medication taken daily over 8 weeks. 3. Acupressure- a mobile health program- self-administered mHealth program with daily practice over 8 weeks. 4. PRISM- cognitive-behavioral therapy plus resilience training- 8, weekly, digitally delivered pain self-management modules with corresponding weekly 15…
Eligibility
- Age range
- 25+ years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DeviceAlgorithmically informed randomization (taking into account phenotypes)
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment. And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
- BehavioralPhysical Therapy (PT) and Exercise
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines. Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
- BehavioralCognitive-Behavioral Therapy for Pain (PRISM-CBT)
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy. Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
- BehavioralmHealth Acupressure Self-Management:
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction. Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
Location
- University of MichiganAnn Arbor, Michigan