The Back Pain Consortium Research Program Study
CompletedPhase 4NCT04870957
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program
- Conditions
- Interventions
- Behavioral: PainGuide
- Behavioral: MBSR
- Behavioral: PT and exercise
- Device: Self -administered acupressure
- Drug: Duloxetine
- Device: Pro-Diary monitor
- Sponsor
- University of Michigan
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Start date
- 2021-06-09
- Primary completion
- 2024-10-15
- Sex
- All
- Age range
- from 25 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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: dulo…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04870957