RecruitingNot ApplicableNCT07731750

Algorithm-informed Decision-making to Advance Pain Treatment

Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)

Sponsor

University of Michigan

Enrollment

500 participants

Start Date

Jul 23, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain

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.

Eligibility

Min Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Algorithmically informed randomization (taking into account phenotypes), Cognitive-Behavioral Therapy for Pain (PRISM-CBT), and others for people with chronic low-back pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DRUGDuloxetine

This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain. A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated. Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.