University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program
Overview
- Phase
- Phase 4
- Intervention
- MBSR
- Conditions
- Chronic Low-back Pain
- Sponsor
- University of Michigan
- Enrollment
- 494
- Locations
- 1
- Primary Endpoint
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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).
Detailed Description
In addition, the following mechanistic hypothesis and Aims are included: Mindfulness-Based Stress Reduction: Aim 2: the study predicts that patients with chronic low back pain (cLBP) will preferentially respond to this therapy if PROs indicate higher levels of pain catastrophizing, as measured by the Pain Catastrophizing Scale, or lower scores on the Experiences Questionnaire. Aim 3: the study hypothesizes that cLBP patients with decreased activation in response to pain in the subgenual anterior cingulate cortex (sgACC) and Prefrontal Cortex and increased activation in somatosensory cortex (S1) and thalamus will respond preferentially to MBSR. Physical Therapy (PT) and Exercise Aim 2: The primary hypothesis for the light phenotyping protocol is those individuals with the highest scores on the Fear Avoidance Beliefs Questionnaire and lowest scores for PROMIS Self-Efficacy for Managing Symptoms will be most likely to improve from PT/Exercise program. Aim 3: the study hypothesis that low vagal tone and high basal inflammation will predict responsiveness to the PT/Exercise program. Acupressure: Aim 2: The study hypothesizes that females with cLBP will respond better to acupressure than men, as will those with higher scores on the 2011 Fibromyalgia Survey Questionnaire. Aim 3: The study predicts that cLBP patients with higher posterior insula glutamate and/or greater insula - Default Mode Network (DMN) connectivity (as well as increased DMN-S1 connectivity Duloxetine: Aim 2: the study hypothesizes that it will replicate previous studies suggesting that participants with cLBP will preferentially respond to this therapy if patient reported outcomes indicate stronger elements of either neuropathic pain (indicated by a high PainDETECT score) or centralized/nociplastic pain (indicated by more widespread pain on the 2011 Fibromyalgia Survey Questionnaire). Aim 3: the study anticipates then that deficient pain inhibition on quantitative sensory testing, decreased periaqueductal gray (PAG)-insula connectivity, and elevated stimulated inflammatory responses will be associated with a positive response to centrally-acting duloxetine. Additionally, a subset of individuals (n=160) from these groups will be asked to participate in an expanded phenotyping study that will include structural and functional brain neuroimaging, quantitative sensory testing (QST), plasma measures of inflammation, and digital measurement of autonomic tone.
Investigators
Afton Hassett, Psy.D.
Associate Professor of Anesthesiology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MBSR (mindfulness-based stress reduction)
Participants receiving MBSR during Treatment 1 or 2.
Intervention: MBSR
MBSR (mindfulness-based stress reduction)
Participants receiving MBSR during Treatment 1 or 2.
Intervention: Pro-Diary monitor
PT and exercise
Participants receiving PT during Treatment 1 or 2.
Intervention: PT and exercise
PT and exercise
Participants receiving PT during Treatment 1 or 2.
Intervention: Pro-Diary monitor
Acupressure
Participants receiving Acupresure during Treatment 1 or 2.
Intervention: Self -administered acupressure
Acupressure
Participants receiving Acupresure during Treatment 1 or 2.
Intervention: Pro-Diary monitor
Duloxetine
Participants receiving Duloxetine during Treatment 1 or 2.
Intervention: Duloxetine
Duloxetine
Participants receiving Duloxetine during Treatment 1 or 2.
Intervention: Pro-Diary monitor
Run-In
Pre-treatment run-in period with access to the PainGuide self management platform.
Intervention: PainGuide
Run-In
Pre-treatment run-in period with access to the PainGuide self management platform.
Intervention: Pro-Diary monitor
Outcomes
Primary Outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)
Time Frame: week 6 (T2), 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.
Secondary Outcomes
- 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))