Algorithm-informed Decision-making to Advance Pain Treatment
ConditionChronic Low-back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Michigan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Algorithmically informed randomization (taking into account phenotypes)
DeviceAfter 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
BehavioralA 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)
BehavioralA 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:
BehavioralA 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
DrugThis 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.
Treatment groups
500 Participants
are divided into 28 treatment groups28
Treatment groupsSee each treatment group below.
Group A: Physical Therapy & Exercise and continueExperimental treatment 2 interventions
Group B: Physical Therapy & Exercise followed by DuloxetineExperimental treatment 3 interventions
Group C: Physical Therapy & Exercise followed by PRISM-CBTExperimental treatment 2 interventions
Group D: Physical Therapy & Exercise followed by AcupressureExperimental treatment 2 interventions
Group E: Physical Therapy & Exercise then add DuloxetineExperimental treatment 3 interventions
Group F: Physical Therapy & Exercise then add PRISM-CBTExperimental treatment 2 interventions
Group G: Physical Therapy & Exercise then add AcupressureExperimental treatment 2 interventions
Group H: Duloxetine and ContinueExperimental treatment 2 interventions
Group I: Duloxetine followed by Physical Therapy & ExerciseExperimental treatment 2 interventions
Group J: Duloxetine followed by PRISM-CBTExperimental treatment 3 interventions
Group K: Duloxetine then add Physical Therapy & ExerciseExperimental treatment 3 interventions
Group L: Duloxetine then add PRISM-CBTExperimental treatment 3 interventions
Group M: Duloxetine then add AcupressureExperimental treatment 3 interventions
Group N: PRISM-CBT and continueExperimental treatment 2 interventions
Group O: PRISM-CBT followed by Physical Therapy & ExerciseExperimental treatment 3 interventions
Group P: PRISM-CBT followed by DuloxetineExperimental treatment 3 interventions
Group Q: PRISM-CBT followed by AcupressureExperimental treatment 3 interventions
Group R: PRISM-CBT then add Physical Therapy & ExerciseExperimental treatment 3 interventions
Group S: PRISM-CBT then add DuloxetineExperimental treatment 3 interventions
Group T: PRISM-CBT then add AcupressureExperimental treatment 3 interventions
Group U: Acupressure then continueExperimental treatment 2 interventions
Group V: Acupressure followed by DuloxetineExperimental treatment 3 interventions
Group W: Acupressure followed by PRISM-CBTExperimental treatment 3 interventions
Group X: Acupressure then add Physical Therapy & ExerciseExperimental treatment 3 interventions
Group Y: Acupressure then add DuloxetineExperimental treatment 3 interventions
Group Z: Acupressure then add PRISM-CBTExperimental treatment 3 interventions
Group [: Duloxetine followed by AcupressureExperimental treatment 2 interventions
Group \: Acupressure followed by Physical Therapy & ExerciseExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
T2 (approximately week 6) - T3 (approximately week 15)Secondary outcomes
1
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.
Time frame
T2 (approximately week 6) - T3 (approximately week 15)2
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".
Time frame
T3 (approximately week 15)3
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."
Time frame
T2 (approximately week 6) - T3 (approximately week 15)4
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
Time frame
T2 (approximately week 6) - T3 (approximately week 15)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov