The Back Pain Consortium Research Program Study
- Conditions
- Chronic Low-back Pain
- Interventions
- Behavioral: PainGuideBehavioral: MBSRBehavioral: PT and exerciseDevice: Self -administered acupressureDevice: Pro-Diary monitor
- Registration Number
- NCT04870957
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 494
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Acupressure PainGuide Run-in treatment then Acupressure Duloxetine Pro-Diary monitor Run-in treatment then Duloxetine MBSR then PT and exercise PainGuide Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise. MBSR then Acupressure PainGuide Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure. MBSR then Acupressure MBSR Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure. MBSR then Duloxetine MBSR Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine MBSR (mindfulness-based stress reduction) PainGuide Run-in treatment then MBSR. PT and exercise PainGuide Run-in treatment then PT and exercise PT and exercise then Acupressure PainGuide Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure MBSR (mindfulness-based stress reduction) MBSR Run-in treatment then MBSR. Acupressure Pro-Diary monitor Run-in treatment then Acupressure PT and exercise then MBSR MBSR Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR. Acupressure then MBSR PainGuide Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR MBSR (mindfulness-based stress reduction) Pro-Diary monitor Run-in treatment then MBSR. MBSR then Duloxetine Pro-Diary monitor Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine PT and exercise then MBSR PainGuide Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR. PT and exercise then MBSR Pro-Diary monitor Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR. PT and exercise PT and exercise Run-in treatment then PT and exercise PT and exercise Pro-Diary monitor Run-in treatment then PT and exercise Acupressure Self -administered acupressure Run-in treatment then Acupressure Duloxetine PainGuide Run-in treatment then Duloxetine MBSR then PT and exercise MBSR Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise. MBSR then Acupressure Pro-Diary monitor Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure. MBSR then Duloxetine PainGuide Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine PT and exercise then Duloxetine PainGuide Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine Acupressure then PT and exercise PainGuide Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise. Acupressure then PT and exercise Self -administered acupressure Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise. MBSR then PT and exercise PT and exercise Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise. MBSR then PT and exercise Pro-Diary monitor Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise. MBSR then Acupressure Self -administered acupressure Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure. PT and exercise then MBSR PT and exercise Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR. PT and exercise then Acupressure Self -administered acupressure Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure PT and exercise then Duloxetine PT and exercise Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine Acupressure then PT and exercise Pro-Diary monitor Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise. Acupressure then Duloxetine PainGuide Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine PT and exercise then Acupressure PT and exercise Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure Acupressure then PT and exercise PT and exercise Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise. Duloxetine then MBSR MBSR Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR. PT and exercise then Acupressure Pro-Diary monitor Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure Acupressure then MBSR Self -administered acupressure Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR Acupressure then Duloxetine Self -administered acupressure Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine Duloxetine then MBSR Pro-Diary monitor Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR. Duloxetine then PT and exercise Pro-Diary monitor Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise Duloxetine then Acupressure Self -administered acupressure Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure. PainGuide PainGuide Run-in treatment only with no additional treatments. PT and exercise then Duloxetine Pro-Diary monitor Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine Acupressure then MBSR MBSR Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR Acupressure then MBSR Pro-Diary monitor Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR Duloxetine then MBSR PainGuide Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR. Duloxetine then Acupressure Pro-Diary monitor Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure. Acupressure then Duloxetine Pro-Diary monitor Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine Duloxetine then PT and exercise PainGuide Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise Duloxetine then Acupressure PainGuide Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure. Duloxetine then PT and exercise PT and exercise Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise Duloxetine Duloxetine Run-in treatment then Duloxetine MBSR then Duloxetine Duloxetine Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine PT and exercise then Duloxetine Duloxetine Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine Acupressure then Duloxetine Duloxetine Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine Duloxetine then MBSR Duloxetine Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR. Duloxetine then PT and exercise Duloxetine Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise Duloxetine then Acupressure Duloxetine Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure.
- Primary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a between week 6 to week 15 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), with higher scores indicating increased pain interference.
- Secondary Outcome Measures
Name Time Method Change in the Pain, Enjoyment, and General Activity Scale (PEG) from week 6 to week 15 week 6 (T2), week 15 (T3) This is a 3 question scale where participants select a between 0 (no pain) to 10 (pain is bad and completely interferes). Higher the scores the worse the pain.
Change in Patient Global Impression of Change (PGIC) from week 6 to week 15 week 6 (T2), week 15 (T3) This is a 1 question item where participants select very much improved (1) to very much worse (7). The lower the score the less pain.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States