Phase 4
N=494
The Back Pain Consortium Research Program Study
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04870957 ↗Enrolled (actual)
494
Serious AEs
2.9%
Results posted
Dec 2025
Primary outcome: Primary: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3) — -0.9; -1.8; -1.6; -2.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PainGuide (Behavioral); MBSR (Behavioral); PT and exercise (Behavioral); Self -administered acupressure (Device); Duloxetine (Drug); Pro-Diary monitor (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3) |
-0.9; -1.8; -1.6; -2.0 | — |
| SECONDARY Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (T3) |
-1.0; -1.5; -0.5; -1.2 | — |
| SECONDARY Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3) |
4; 35; 21; 21; 75; 55 | — |
Summary
This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work.
This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine).
In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study.
Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them.
The study hypothesizes the following:
that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).
Eligibility Criteria
Inclusion Criteria for Light Phenotyping (all participants):
- Definition of cLBP described in the NIH Task Force Report on Research Standards for Chronic Low Back Pain (for example (i.e.), low back pain present at least six months, and present more than half of those days.
- Individuals must have the eligible protocol pain interference score on PROMIS Pain Interference.
- Individuals must be willing to be randomized to receive any of the four proposed treatments.
Exclusion Criteria for Light Phenotyping (all participants):
- History of discitis osteomyelitis (spine infection) or spine tumor
- History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus
- History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing)
- Diagnosis of any vertebral fracture in the last 6 months
- Osteoporosis requiring treatment other than vitamin D and calcium supplements
- Cancer (History of any bone-related cancer or cancer that metastasized to the bone, Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months, History of any cancer treatment in the last 24 months)
- Life expectancy less than 2 years
- Unable to speak and write English
- Visual or hearing difficulties that would preclude participation
- Presence of any history that would preclude scanning in magnetic resonance imaging (MRI)
- Uncontrolled drug/alcohol addiction
- Individuals receiving disability or compensation within the past year, or involved in litigation
- Pregnancy or breastfeeding
- History of allergy to duloxetine
- Individuals on high doses of opioids (over 100 oral morphine equivalents (OME) per day)
- Scheduled back surgery, back surgery within the last year, or more than one back surgery in the past.
- Expecting to receive an injection of surgical procedure within the next year for their cLBP
- 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 history of suicide attempts, and an uncontrolled drug and/or alcohol addiction
Contraindications to Study Intervention: duloxetine
- certain medications (per protocol)
- renal dysfunction (creatinine clearance <30 milliliters per minute (mL/min) or End- Stage Renal Failure)
- Hepatic dysfunction: Liver function tests (LFTs) elevated times 1.5
Contraindications to Study Intervention: Acupressure
- Currently receiving acupressure or acupuncture through formal therapy
Contraindications to Study Intervention: MBSR
- Current participation in a structured MBSR program
Contraindications to Study Intervention: PT & Exercise
- Currently receiving any type of structured manual therapy or exercise treatment for low-back pain.
- Contraindication for manual therapy and/or participation in an exercise program
Inclusion Criteria for Deep Phenotyping (subset 160 participants):
- Right hand dominant (such as the hand used when writing or throwing/catching a ball)
- Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
- No contraindications to MRI (i.e., metal implants)
- Willingness to refrain from taking any "as needed" medications, including pain medications such as Nonsteroidal anti-inflammatory drugs (i.e., Motrin, Advil, Aleve), acetaminophen, and opioids, for 8 hours before undergoing neuroimaging and 10.1 Quantitative Sensory Testing (QST)
- Willingness to refrain from alcohol and nicotine on the day of QST and neuroimaging (alcohol and nicotine consumption is allowed after testing i
Data sourced from ClinicalTrials.gov (NCT04870957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.