Clinical trial NCT03354585: Mindfulness and Chronic Low Back Pain
Official title: Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Mindfulness
fMRI
Pain
Low Back
Radicular
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a six session mindfulness meditation, non-mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete two MRI scans over the course of the study.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. A technique called functional magnetic resonance imaging (fMRI) allows scientists to determine which parts of the brain are active during a particular task. This study will provide new information about how mindfulness affects the brain.

Detailed description: To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP) patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC), subgenual anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). Each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.

Eligibility criteria: Inclusion criteria are:

* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis. This will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on MRI.
* Participants must be between the ages of 18-65 years.
* Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.
* Participants must have experienced their radicular pain for at least 3 months duration.
* Participants must be right-handed.
* Participants must have no prior meditative experience

Exclusion criteria:

* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period.
* Participants must not have had back surgery within the last year before their enrollment into the study.
* Participants must not have had any other sensory or motor deficits that precludes participation in this study.
* Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis.
* Participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, BBs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed.
* Participants must not be claustrophobic.
* Participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less).
* Participants must not be pregnant
* Participants must not be over 275 pounds

Primary outcomes:
measure: Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
timeFrame: There will be up to 2 fMRI sessions (Visit 2, and 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Secondary outcomes:
measure: Visual Analog Scale Pain Ratings
timeFrame: Baseline and 3 fMRI sessions (Visit 1, 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Numerical Pain Ratings
timeFrame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Blood Oxygen Dependent Signaling
timeFrame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Respiration Rate
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Five Facet Mindfulness Questionnaire
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: PROMIS Pain Behavior Measure
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Brief Pain Inventory
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Pain Catastrophizing Scale
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Beck Depression Inventory
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Freiburg Mindfulness Inventory
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Roland-Morris Disability Questionnaire
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Cohen Perceived Stress Scale
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Other outcomes:
measure: Social Connectedness Scale
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Perceived Intervention Effectiveness
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Positive and Negative Affect Scale
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Pittsburgh Sleep Quality Index
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: SF 12 Health Survey
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: State Anxiety Inventory
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: PROMIS Pain Quality Measure
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: PROMIS 29-Item Profile
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Patients' Global Impression of Change
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Profile of Mood States Form
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Pain Self Efficacy Questionnaire
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
measure: Chronic Pain Acceptance Questionnaire
timeFrame: There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: La Jolla
country: United States
facility: UC San Diego Center for Functional MRI
state: California
Study officials:
affiliation: Principal Investigator
name: Fadel Zeidan, PhD
role: PRINCIPAL_INVESTIGATOR
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