Chronic Low-back PainADAPTNCT07731750
Algorithm-informed Decision-making to Advance Pain Treatment
A study testing Algorithmically informed randomization (taking into account phenotypes), Physical Therapy (PT) and Exercise and Cognitive-Behavioral Therapy for Pain (PRISM-CBT) in people with Chronic Low-back Pain, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Algorithmically informed randomization (taking into account phenotypes), Physical Therapy (PT) and Exercise and Cognitive-Behavioral Therapy for Pain (PRISM-CBT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Beth Banner, 734-763-5226, eledward@med.umich.edu
Sana Shaikh, 734-763-5226, skazi@med.umich.edu
About this study
Official title: Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
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.
Read the detailed description
During the treatment stages participants may be placed into the following interventions:
- Physical Therapy \& Exercise -10, standardized sessions over 8 weeks delivered individually and in-person by a physical therapist
- Duloxetine - FDA approved for musculoskeletal pain, self-administered SNRI medication taken daily over 8 weeks.
- Acupressure- a mobile health program- self-administered mHealth program with daily practice over 8 weeks.
- PRISM- cognitive-behavioral therapy plus resilience training- 8, weekly, digitally delivered pain self-management modules with corresponding weekly 15-minute standardized telehealth coaching sessions.
After participants are placed in an initial assignment based on a combination of the use of the phenotype based algorithm and randomization, they have the option of continuing on that treatment, switching to another (to be assigned by another randomization combined with use of the algorithm) or adding a second treatment to the first (to be assigned by another randomization combined with use of the algorithm).
Analysis of results will not be a function of the arms listed here, but on whether those allocations were based on the algorithm assigning them initially to their presumed "most effective" treatment; or to a potentially less effective treatment (2nd, 3rd or 4th, choice). These "ranked phenotypic" assignments are masked from participants and researchers until after the trial is completed.
- Conditions
- Chronic Low-back Pain
- Being tested
- Algorithmically informed randomization (taking into account phenotypes), Physical Therapy (PT) and Exercise, Cognitive-Behavioral Therapy for Pain (PRISM-CBT), mHealth Acupressure Self-Management:, Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ExerciseBehavioural
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)Behavioural
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:Behavioural
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.
DuloxetineDrug
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 group | Role | What they receive |
|---|---|---|
| Physical Therapy & Exercise and continue | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise followed by Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Drug: Duloxetine |
| Physical Therapy & Exercise followed by PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise followed by Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise then add Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Drug: Duloxetine |
| Physical Therapy & Exercise then add PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise then add Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise |
| Duloxetine and Continue | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Drug: Duloxetine |
| Duloxetine followed by Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Drug: Duloxetine |
| Duloxetine followed by PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Drug: Duloxetine |
| Duloxetine then add Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Drug: Duloxetine |
| Duloxetine then add PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Drug: Duloxetine |
| Duloxetine then add Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: mHealth Acupressure Self-Management:; Drug: Duloxetine |
| PRISM-CBT and continue | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT followed by Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT followed by Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Drug: Duloxetine |
| PRISM-CBT followed by Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Behavioral: mHealth Acupressure Self-Management: |
| PRISM-CBT then add Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT then add Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Drug: Duloxetine |
| PRISM-CBT then add Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then continue | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: mHealth Acupressure Self-Management: |
| Acupressure followed by Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: mHealth Acupressure Self-Management:; Drug: Duloxetine |
| Acupressure followed by PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then add Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then add Duloxetine | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: mHealth Acupressure Self-Management:; Drug: Duloxetine |
| Acupressure then add PRISM-CBT | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT); Behavioral: mHealth Acupressure Self-Management: |
| Duloxetine followed by Acupressure | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Drug: Duloxetine |
| Acupressure followed by Physical Therapy & Exercise | Experimental | Not described Receives: Device: Algorithmically informed randomization (taking into account phenotypes); Behavioral: Physical Therapy (PT) and Exercise; Behavioral: mHealth Acupressure Self-Management: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T2 (approximately week 6) - T3 (approximately week 15)
Secondary outcomes (4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Interference from pain is assessed using 6 items covering broad functional domains such as life enjoyment, concentration, daily activities, recreation, tasks, and socializing. The scale uses a recall period of 7 days and a response set ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 4 and 20, with higher scores indicating increased pain interference.
Measured: T2 (approximately week 6) - T3 (approximately week 15)
Patient Global Impression of Pain (PGIC)
Overall perceived benefit of treatment will be assessed using the Patient Global Impression of Change (PGIC).34 This single-item question asks "Overall, how do you feel since the beginning of this phase of the study", and participants respond on a 1 - 7 Likert scale where 1 = markedly improved, 2 = somewhat improved, 3 = mildly improved, 4 = the same, and 5 - 7 are correspondingly "worsened".
Measured: T3 (approximately week 15)
Change in ecological momentary assessment (EMA)-derived mean Pain Interference
Real-time 7-day pain severity measure assessed using Qualtrics. In practice, participants initiate EMAs at wake, noon and bed-times. Momentary pain intensity will be assessed with the question: "What is your level of pain right now?" rated on a numerical rating scale from 0 = "no pain" to 10 = "worst pain imaginable."
Measured: T2 (approximately week 6) - T3 (approximately week 15)
Change in Oswestry Disability Index (ODI) scores
This 10-section scale has good internal consistency, discriminative validity, and sensitivity to change in cLBP. Respondents check the box next to each statement that describes their pain or disability
Measured: T2 (approximately week 6) - T3 (approximately week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start23 Jul 2026
- Primary completionFeb 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study employs an enhanced, phenotype-informed Sequential, Multiple Assignment, Randomized Trial (SMART) design that integrates biomarker strategy principles to evaluate individualized, adaptive treatment pathways. This design enables the examination of treatment effectiveness across biological, behavioral, and psychosocial domains, thereby advancing the precision-medicine approach to chronic pain management.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Afton Hassett, Psy.D., University of Michigan
- Investigators
- Afton Hassett, PsyD, Principal investigator, University of MichiganDaniel Clauw, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731750
- Sponsor's protocol ID
- HUM00273626
- Other IDs
- UC2AR086182
- Acronym
- ADAPT
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
- ClinicalTrials.gov ID
- NCT07731750
- Acronym / sponsor ID
- ADAPT / HUM00273626
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the treatment stages participants may be placed into the following interventions:
- Physical Therapy \& Exercise -10, standardized sessions over 8 weeks delivered individually and in-person by a physical therapist
- Duloxetine - FDA approved for musculoskeletal pain, self-administered SNRI medication taken daily over 8 weeks.
- Acupressure- a mobile health program- self-administered mHealth program with daily practice over 8 weeks.
- PRISM- cognitive-behavioral therapy plus resilience training- 8, weekly, digitally delivered pain self-management modules with corresponding weekly 15-minute standardized telehealth coaching sessions.
After participants are placed in an initial assignment based on a combination of the use of the phenotype based algorithm and randomization, they have the option of continuing on that treatment, switching to another (to be assigned by another randomization combined with use of the algorithm) or adding a second treatment to the first (to be assigned by another randomization combined with use of the algorithm).
Analysis of results will not be a function of the arms listed here, but on whether those allocations were based on the algorithm assigning them initially to their presumed "most effective" treatment; or to a potentially less effective treatment (2nd, 3rd or 4th, choice). These "ranked phenotypic" assignments are masked from participants and researchers until after the trial is completed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 28
- Model description
- The study employs an enhanced, phenotype-informed Sequential, Multiple Assignment, Randomized Trial (SMART) design that integrates biomarker strategy principles to evaluate individualized, adaptive treatment pathways. This design enables the examination of treatment effectiveness across biological, behavioral, and psychosocial domains, thereby advancing the precision-medicine approach to chronic pain management.
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy & Exercise and continue | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise followed by Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Drug: Duloxetine |
| Physical Therapy & Exercise followed by PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise followed by Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise then add Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Drug: Duloxetine |
| Physical Therapy & Exercise then add PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise |
| Physical Therapy & Exercise then add Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise |
| Duloxetine and Continue | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Drug: Duloxetine |
| Duloxetine followed by Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Drug: Duloxetine |
| Duloxetine followed by PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Drug: Duloxetine |
| Duloxetine then add Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Drug: Duloxetine |
| Duloxetine then add PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Drug: Duloxetine |
| Duloxetine then add Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: mHealth Acupressure Self-Management:, Drug: Duloxetine |
| PRISM-CBT and continue | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT followed by Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT followed by Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Drug: Duloxetine |
| PRISM-CBT followed by Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Behavioral: mHealth Acupressure Self-Management: |
| PRISM-CBT then add Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) |
| PRISM-CBT then add Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Drug: Duloxetine |
| PRISM-CBT then add Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then continue | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: mHealth Acupressure Self-Management: |
| Acupressure followed by Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: mHealth Acupressure Self-Management:, Drug: Duloxetine |
| Acupressure followed by PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then add Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Behavioral: mHealth Acupressure Self-Management: |
| Acupressure then add Duloxetine | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: mHealth Acupressure Self-Management:, Drug: Duloxetine |
| Acupressure then add PRISM-CBT | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Behavioral: mHealth Acupressure Self-Management: |
| Duloxetine followed by Acupressure | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Drug: Duloxetine |
| Acupressure followed by Physical Therapy & Exercise | Experimental | Device: Algorithmically informed randomization (taking into account phenotypes), Behavioral: Physical Therapy (PT) and Exercise, Behavioral: mHealth Acupressure Self-Management: |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Acupressure followed by Duloxetine, Acupressure followed by PRISM-CBT, Acupressure followed by Physical Therapy & Exercise, Acupressure then add Duloxetine, Acupressure then add PRISM-CBT, Acupressure then add Physical Therapy & Exercise, Acupressure then continue, Duloxetine and Continue, Duloxetine followed by Acupressure, Duloxetine followed by PRISM-CBT, Duloxetine followed by Physical Therapy & Exercise, Duloxetine then add Acupressure, Duloxetine then add PRISM-CBT, Duloxetine then add Physical Therapy & Exercise, PRISM-CBT and continue, PRISM-CBT followed by Acupressure, PRISM-CBT followed by Duloxetine, PRISM-CBT followed by Physical Therapy & Exercise, PRISM-CBT then add Acupressure, PRISM-CBT then add Duloxetine, PRISM-CBT then add Physical Therapy & Exercise, Physical Therapy & Exercise and continue, Physical Therapy & Exercise followed by Acupressure, Physical Therapy & Exercise followed by Duloxetine, Physical Therapy & Exercise followed by PRISM-CBT, Physical Therapy & Exercise then add Acupressure, Physical Therapy & Exercise then add Duloxetine, Physical Therapy & Exercise then add PRISM-CBT |
| Physical Therapy (PT) and ExerciseA 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. | Behavioural | Acupressure followed by Physical Therapy & Exercise, Acupressure then add Physical Therapy & Exercise, Duloxetine then add Physical Therapy & Exercise, PRISM-CBT followed by Physical Therapy & Exercise, PRISM-CBT then add Physical Therapy & Exercise, Physical Therapy & Exercise and continue, Physical Therapy & Exercise followed by Acupressure, Physical Therapy & Exercise followed by Duloxetine, Physical Therapy & Exercise followed by PRISM-CBT, Physical Therapy & Exercise then add Acupressure, Physical Therapy & Exercise then add Duloxetine, Physical Therapy & Exercise then add PRISM-CBT |
| 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. | Behavioural | Acupressure followed by PRISM-CBT, Acupressure then add PRISM-CBT, Duloxetine followed by PRISM-CBT, Duloxetine then add PRISM-CBT, PRISM-CBT and continue, PRISM-CBT followed by Acupressure, PRISM-CBT followed by Duloxetine, PRISM-CBT followed by Physical Therapy & Exercise, PRISM-CBT then add Acupressure, PRISM-CBT then add Duloxetine, PRISM-CBT then add Physical Therapy & Exercise |
| 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. | Behavioural | Acupressure followed by Duloxetine, Acupressure followed by PRISM-CBT, Acupressure followed by Physical Therapy & Exercise, Acupressure then add Duloxetine, Acupressure then add PRISM-CBT, Acupressure then add Physical Therapy & Exercise, Acupressure then continue, Duloxetine then add Acupressure, PRISM-CBT followed by Acupressure, PRISM-CBT then add Acupressure |
| DuloxetineThis 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. | Drug | Acupressure followed by Duloxetine, Acupressure then add Duloxetine, Duloxetine and Continue, Duloxetine followed by Acupressure, Duloxetine followed by PRISM-CBT, Duloxetine followed by Physical Therapy & Exercise, Duloxetine then add Acupressure, Duloxetine then add PRISM-CBT, Duloxetine then add Physical Therapy & Exercise, PRISM-CBT followed by Duloxetine, PRISM-CBT then add Duloxetine, Physical Therapy & Exercise followed by Duloxetine, Physical Therapy & Exercise then add Duloxetine |
Primary outcome
Change in Pain, Enjoyment and General Activity (PEG) scores
Time frame: T2 (approximately week 6) - T3 (approximately week 15)
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.
4 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Time frame: T2 (approximately week 6) - T3 (approximately week 15)
Patient Global Impression of Pain (PGIC)
Time frame: T3 (approximately week 15)
Change in ecological momentary assessment (EMA)-derived mean Pain Interference
Time frame: T2 (approximately week 6) - T3 (approximately week 15)
Change in Oswestry Disability Index (ODI) scores
Time frame: T2 (approximately week 6) - T3 (approximately week 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afton Hassett, PsyD principal investigator
University of Michigan
Daniel Clauw, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithmically informed randomization (taking into account phenotypes), Physical Therapy (PT) and Exercise and Cognitive-Behavioral Therapy for Pain (PRISM-CBT) in people with Chronic Low-back Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Banner (734-763-5226, eledward@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain, Enjoyment and General Activity (PEG) scores (time frame: T2 (approximately week 6) - T3 (approximately week 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.