Algorithm-informed Decision-making to Advance Pain Treatment

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07731750
Status
Not Yet Recruiting

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Conditions

  • Chronic Low-back Pain

Eligibility Criteria

Sex
ALL
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Physical Therapy & Exercise and continue
  • Experimental: Physical Therapy & Exercise followed by Duloxetine
  • Experimental: Physical Therapy & Exercise followed by PRISM-CBT
  • Experimental: Physical Therapy & Exercise followed by Acupressure
  • Experimental: Physical Therapy & Exercise then add Duloxetine
  • Experimental: Physical Therapy & Exercise then add PRISM-CBT
  • Experimental: Physical Therapy & Exercise then add Acupressure
  • Experimental: Duloxetine and Continue
  • Experimental: Duloxetine followed by Physical Therapy & Exercise
  • Experimental: Duloxetine followed by PRISM-CBT
  • Experimental: Duloxetine then add Physical Therapy & Exercise
  • Experimental: Duloxetine then add PRISM-CBT
  • Experimental: Duloxetine then add Acupressure
  • Experimental: PRISM-CBT and continue
  • Experimental: PRISM-CBT followed by Physical Therapy & Exercise
  • Experimental: PRISM-CBT followed by Duloxetine
  • Experimental: PRISM-CBT followed by Acupressure
  • Experimental: PRISM-CBT then add Physical Therapy & Exercise
  • Experimental: PRISM-CBT then add Duloxetine
  • Experimental: PRISM-CBT then add Acupressure
  • Experimental: Acupressure then continue
  • Experimental: Acupressure followed by Duloxetine
  • Experimental: Acupressure followed by PRISM-CBT
  • Experimental: Acupressure then add Physical Therapy & Exercise
  • Experimental: Acupressure then add Duloxetine
  • Experimental: Acupressure then add PRISM-CBT
  • Experimental: Duloxetine followed by Acupressure
  • Experimental: Acupressure followed by Physical Therapy & Exercise

Primary Outcome Measure

Change in Pain, Enjoyment and General Activity (PEG) scores [ Time Frame: T2 (approximately week 6) - T3 (approximately week 15) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Beth Banner
[email protected]
734-763-5226
Sana Shaikh
[email protected]
734-763-5226
Afton Hassett, PsyD (PRINCIPAL_INVESTIGATOR)
Daniel Clauw, MD (PRINCIPAL_INVESTIGATOR)

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