Recruiting

Predicting Treatments

Sponsor:

University of Michigan

Code:

NCT07731750

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Algorithmically informed randomization (taking into account phenotypes)

Physical Therapy (PT) and Exercise

Cognitive-Behavioral Therapy for Pain (PRISM-CBT)

mHealth Acupressure Self-Management:

Duloxetine

Study Details

Brief 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.

Conditions

Chronic Low-back Pain

Study ID

NCT07731750

Start date

Jul 23, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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 determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or recent suicide attempts

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Algorithmically 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.

Physical 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.

Cognitive-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.

mHealth 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.

Duloxetine

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Beth Banner

734-763-5226eledward@med.umich.edu

Sana Shaikh

734-763-5226skazi@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Beth Banner

734-763-5226eledward@med.umich.edu

Sana Shaikh

734-763-5226skazi@med.umich.edu

Principal Investigator:

Afton Hassett, PsyD

More Information

Sponsor

University of Michigan

Last update posted

Sep 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-15.