Algorithm-informed Decision-making to Advance Pain Treatment
ADAPT
2 other identifiers
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
July 28, 2026
July 1, 2026
3.6 years
July 22, 2026
July 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain, Enjoyment and General Activity (PEG) scores
The PEG is a three-item survey measure used to assess pain by asking for ratings of Pain intensity, Enjoyment of life, and General activity on a scale of 0-10 over the past week. The final score is the average of the three ratings, with higher scores indicating greater pain severity or interference.
T2 (approximately week 6) - T3 (approximately week 15)
Secondary Outcomes (4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
T2 (approximately week 6) - T3 (approximately week 15)
Patient Global Impression of Pain (PGIC)
T3 (approximately week 15)
Change in ecological momentary assessment (EMA)-derived mean Pain Interference
T2 (approximately week 6) - T3 (approximately week 15)
Change in Oswestry Disability Index (ODI) scores
T2 (approximately week 6) - T3 (approximately week 15)
Study Arms (28)
Physical Therapy & Exercise and continue
EXPERIMENTALPhysical Therapy & Exercise followed by Duloxetine
EXPERIMENTALPhysical Therapy & Exercise followed by PRISM-CBT
EXPERIMENTALPhysical Therapy & Exercise followed by Acupressure
EXPERIMENTALPhysical Therapy & Exercise then add Duloxetine
EXPERIMENTALPhysical Therapy & Exercise then add PRISM-CBT
EXPERIMENTALPhysical Therapy & Exercise then add Acupressure
EXPERIMENTALDuloxetine and Continue
EXPERIMENTALDuloxetine followed by Physical Therapy & Exercise
EXPERIMENTALDuloxetine followed by PRISM-CBT
EXPERIMENTALDuloxetine then add Physical Therapy & Exercise
EXPERIMENTALDuloxetine then add PRISM-CBT
EXPERIMENTALDuloxetine then add Acupressure
EXPERIMENTALPRISM-CBT and continue
EXPERIMENTALPRISM-CBT followed by Physical Therapy & Exercise
EXPERIMENTALPRISM-CBT followed by Duloxetine
EXPERIMENTALPRISM-CBT followed by Acupressure
EXPERIMENTALPRISM-CBT then add Physical Therapy & Exercise
EXPERIMENTALPRISM-CBT then add Duloxetine
EXPERIMENTALPRISM-CBT then add Acupressure
EXPERIMENTALAcupressure then continue
EXPERIMENTALAcupressure followed by Duloxetine
EXPERIMENTALAcupressure followed by PRISM-CBT
EXPERIMENTALAcupressure then add Physical Therapy & Exercise
EXPERIMENTALAcupressure then add Duloxetine
EXPERIMENTALAcupressure then add PRISM-CBT
EXPERIMENTALDuloxetine followed by Acupressure
EXPERIMENTALAcupressure followed by Physical Therapy & Exercise
EXPERIMENTALInterventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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 be willing and eligible to receive at least three of the four proposed interventions.
- Able to stand for at least 10 minutes
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Afton Hassett, PsyD
University of Michigan
- PRINCIPAL INVESTIGATOR
Daniel Clauw, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In ADAPT, participants are blinded to whether they are assigned to the Restricted Random Assignment (RRA) group or the Phenotype-Informed Assignment (PIA) group. Participants are only informed of their treatment assignment not assignment type. Internally, the study team refers to the two study groups as "Maize" and "Blue" to maintain blinding. In the consent form, the study team does not explicitly describe the two assignment groups. Instead, the study team explains that an algorithm will be used to help determine treatment assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology, Associate Professor of Internal Medicine and Program Director, Anesthesiology
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 28, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The data will be made available when the study is completed and available as long as the NIH deems appropriate.
- Access Criteria
- All researchers/members of the scientific community including those outside of the study. Please contact the study team for additional guidance. Requesters will sign a Letter of Agreement with the University of Michigan detailing their planned uses of the data and mechanisms by which the data will be kept secure, and access restricted to their study team with appropriate credentials and training in data security. The agreements will also state the recipient will not attempt to identify (or taking steps to identify or re-identify) any individual whose data are included and will not share the data with anyone outside of their research team.
After the study is completed, the de-identified, archived data may also be transmitted to and stored in a data repository for use by other researchers including those outside of the study as per the cooperative agreement with the study sponsor, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).