The Back Pain Consortium Research Program Study
BACPAC
University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program
2 other identifiers
interventional
494
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2025
CompletedResults Posted
Study results publicly available
December 5, 2025
CompletedDecember 5, 2025
October 1, 2025
3.4 years
April 28, 2021
October 15, 2025
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)
The PROMIS pain interference consists of 4 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 4 and 20, with higher scores indicating increased pain interference.
week 6 (T2), week 15 (T3)
Secondary Outcomes (2)
Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (T3)
week 6 (T2), week 15 (T3)
Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3)
week 15 (T3)
Study Arms (6)
MBSR (mindfulness-based stress reduction)
EXPERIMENTALParticipants receiving MBSR during Treatment 1 or 2.
PT and exercise
EXPERIMENTALParticipants receiving PT during Treatment 1 or 2.
Acupressure
EXPERIMENTALParticipants receiving Acupresure during Treatment 1 or 2.
Duloxetine
EXPERIMENTALParticipants receiving Duloxetine during Treatment 1 or 2.
Run-In
EXPERIMENTALPre-treatment run-in period with access to the PainGuide self management platform.
Follow-Up
NO INTERVENTIONParticipants on Follow-Up at any timepoint throughout the study.
Interventions
Participants will wear during 5 separate 7-day "home monitoring" periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.
A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.
In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour "retreat". During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.
Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.
A device called the "AcuWand" will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called "MeTime" that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.
For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48170, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Afton Hassett, PsyD
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Afton Hassett, PsyD
University of Michigan
- PRINCIPAL INVESTIGATOR
Daniel Clauw, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 4, 2021
Study Start
June 9, 2021
Primary Completion
October 15, 2024
Study Completion
April 14, 2025
Last Updated
December 5, 2025
Results First Posted
December 5, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Per the study data sharing plan, data will be shared to the consortial DAC at fixed intervals after 20% completion is attained (and then at each subsequent 20%). The consortium currently plans for perpetual access for consortial partners.
- Access Criteria
- The data will be available only to members of the consortium and is governed by a consortial data use agreement. Members must submit a request form for data access. The Data Access and Publications Committee will review requests and notify Data Access Team when access can be granted.
Data (including bio-specimens, omic data, raw imaging data, and other study data) will be shared with consortial partners. Data will be held at a Data Acquisition Center (DAC) hosted at the University of North Carolina. Omics data will be shared through NIH portals as required. Data dictionaries are harmonized across study sites and shared with consortial partners.