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Mindfulness and Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Meditation training

Meditatin training

Book Listening Control

About this trial

This is an interventional basic science trial for Chronic Low Back Pain focused on measuring Mindfulness, fMRI, Pain, Low Back, Radicular

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UC San Diego Center for Functional MRIRecruiting
UC San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Meditation Group

Meditatin Group

Book Listening Control Group

Arm Description

Study volunteers will participate in a twelve-session meditation training regimen. In brief, subjects will be taught that perceived sensory events are "momentary" and "fleeting" and do not require further evaluation. There will be an emphasis on breath focus and altering one's perspective of discursive sensory events. This intervention has been found to reliably attenuate the subjective experience of pain.

Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 12 session intervention is meant to provide the control attention to the facilitator, room setting, social support, conditioning, and the time elapsed during the other respective interventions. We do not expect that this group will demonstrate significant cerebral blood flow changes as a function of the intervention.

Outcomes

Primary Outcome Measures

Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)

Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.

Secondary Outcome Measures

Visual Analog Scale Pain Ratings

Visual analog scale (VAS) pain ratings will be assessed in response to the straight leg raise test and lying supine in the MRI scanner. Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher numbers correspond to higher perceived pain

Respiration Rate

Respiration rate will be collected and recorded on a Biopac respiratory transducer. Changes in respiration rate could be predictive of analgesia and health promotion.

Five Facet Mindfulness Questionnaire

This is a 39-item multidimensional measure of trait mindfulness and includes five subscales: non-reactivity, nonjudgment, describing, observing, and acting with awareness. A numeric value between 1 (never or very rarely true) and 5 (very often or always true) is provided in response to each statement.

Profile of Mood States Form

This is a 40-item core measure of emotional functioning and includes 6 mood states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. A numeric value between 1 (not at all) and 5 (extremely) is provided in response to each statement. Total mood disturbance scoring is calculated by summing the totals for the negative subscales and then subtracting the totals for the positive subscales.

Patients' Global Impression of Change

This is a self-report assessment measured on a 7-point scaled designed to evaluate perceived improvement over trial/efficacy of treatment. Options range from "no change" to "a great deal better, and a considerable improvement that has made all the difference." Higher ratings indicate greater impressions of change.

Pain Self Efficacy Questionnaire

This is a 10-item questionnaire that's designed to assess the confidence in people with ongoing pain have in performing activities while in pain. The option of either "not at all confident" or "completely confident" is posed after each item. Scores on this assessment range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs.

PROMIS 29-Item Profile

This is a 29-item generic health-related survey that assesses 7 domains with 4-items in each domain: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participant in social roles/activities. Higher scores represent different outcomes based on domain. Higher scores on symptom-oriented domains represent worse symptomatology, but higher scores on function-oriented domains represent better functioning.

PROMIS Pain Behavior Measure

This is a 5-item questionnaire that measures complaints of suffering, verbal or nonverbal (i.e. such as when I am in pain I squirm) from the past 7 days. Scoring for this measure is item-content dependent.

PROMIS Pain Quality Measure

This is a 5-item questionnaire that measures sensory quality of pain experience (throbbing, aching, etc). A numeric value between 1 (not at all) and 5 (very much) is provided in response to each statement. Higher scores indicate a greater quality of pain.

Chronic Pain Acceptance Questionnaire

This is a 20-item assessment designed to measure acceptance of pain. Items are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance.

State Anxiety Inventory

This inventory is a 20-item assessment used to measure a subject's state of anxiety. A numeric value between 1 (Not at all) and 4 (Very Much So) is provided in response to each statement. The range of scores for this test is between 20 and 80, with higher scores reflecting higher estimates of anxiety.

Brief Pain Inventory

This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain.

SF 12 Health Survey

This is a 12-item version of the SF-36 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. Scores on this assessment range from 0 to 100, where a higher score indicates a higher level of overall health.

Pain Catastrophizing Scale

This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience.

Beck Depression Inventory

This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.

Freiburg Mindfulness Inventory

This is a 14-item standard mindfulness scale to measure potential changes in mindfulness before and after intervention. A rating between "rarely" (0) to "often" (4) is provided in response to each statement.

Roland-Morris Disability Questionnaire

This is a critical assessment for assessing the functional impact of chronic low back pain. Scores on this assessment range from 0 to 24, where higher scores indicate greater disability and limited functioning due to pain.

Pittsburgh Sleep Quality Index

This is a 10-item assessment designed to measure quality of sleep. This measure is scored along a 5-point Likert scale with values ranging from 0 to 5, specific ratings associated with particular items. Scores on this assessment range from 0 to 28, with higher values reflecting greater levels of insomnia.

Cohen Perceived Stress Scale

The CPS is a series of 10 temporally constrained (i.e. in the last month) questions meant to ascertain the relative frequency of stressors in one's life, ranging from never (scored as 0) to very often (scored as 4). All positively stated questions are reversed scored and then all items are summed to yield a final estimate of stress. The higher the score the higher the level of stress.

Positive and Negative Affect Scale

This is a 20-item self-report assessment used to assess positive and negative affect in a participant. A rating between "very slightly or not at all" (1) to "extremely" (5) is provided in response to each statement. Higher scores indicate a greater level of positive affect, and a lower score reveals a greater level of negative affect.

Perceived Intervention Effectiveness

This measure will be assessed with a VAS ("0" = not effective at all; "10"= most effective imaginable) for each intervention session's respective manipulation.

Social Connectedness Scale

This is a 20-item assessment designed to measure social connectedness, an attribute of the self that reflects cognitions of enduring interpersonal closeness with the social world, in participants. Higher scores on the Social Connectedness Scale reflect a stronger sense of social connectedness, there are no sub-scales. The minimum score is 20 and the maximum score is 120.

Full Information

NCT ID

NCT03354585

First Posted

October 16, 2017

Last Updated

April 5, 2022

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT03354585

Brief Title

Mindfulness and Chronic Low Back Pain

Official Title

Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

October 2, 2024 (Anticipated)

Study Completion Date

October 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

You have been asked to participate in this study because you are interested in learning mindfulness and have been diagnosed with chronic low-back pain. Your participation is voluntary. We will randomly assign 40 subjects to each group for the initiation of the final phase of the study. Randomization means that you have a one in two chance of being assigned to the mindfulness meditation training or book-listening control intervention. Your assignment is based on chance rather than a medical decision made by the researchers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Mindfulness, fMRI, Pain, Low Back, Radicular

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using visual analog scales (11 point) obtained before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a twelve session mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete three MRI scans over the course of the study.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Only the study physician, research coordinator, and intervention facilitators will be aware of group assignment.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Meditation Group

Arm Type

Experimental

Arm Description

Arm Title

Meditatin Group

Arm Type

Active Comparator

Arm Description

Arm Title

Book Listening Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Meditation training

Other Intervention Name(s)

mental training

Intervention Description

A well-validated brief mindfulness-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.

Intervention Type

Behavioral

Intervention Name(s)

Meditatin training

Other Intervention Name(s)

mental training

Intervention Description

A well-validated brief meditation-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.

Intervention Type

Behavioral

Intervention Name(s)

Book Listening Control

Intervention Description

Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.

Primary Outcome Measure Information:

Title

Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)

Description

Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.

Time Frame

There will be up to 3 fMRI sessions (Visit 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments..

Secondary Outcome Measure Information:

Title

Visual Analog Scale Pain Ratings

Description

Time Frame

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.

Title

Respiration Rate

Description

Respiration rate will be collected and recorded on a Biopac respiratory transducer. Changes in respiration rate could be predictive of analgesia and health promotion.

Time Frame

There will be up to 3 fMRI sessions (Visit 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Title

Five Facet Mindfulness Questionnaire

Description

Time Frame

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.

Title

Profile of Mood States Form

Description

Time Frame

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.

Title

Patients' Global Impression of Change

Description

Time Frame

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.

Title

Pain Self Efficacy Questionnaire

Description

Time Frame

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.

Title

PROMIS 29-Item Profile

Description

Time Frame

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.

Title

PROMIS Pain Behavior Measure

Description

Time Frame

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.

Title

PROMIS Pain Quality Measure

Description

Time Frame

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.

Title

Chronic Pain Acceptance Questionnaire

Description

This is a 20-item assessment designed to measure acceptance of pain. Items are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance.

Time Frame

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.

Title

State Anxiety Inventory

Description

Time Frame

Baseline, all intervention sessions, and 3 fMRI sessions (Visit 1-16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Title

Brief Pain Inventory

Description

This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain.

Time Frame

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.

Title

SF 12 Health Survey

Description

Time Frame

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.

Title

Pain Catastrophizing Scale

Description

Time Frame

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.

Title

Beck Depression Inventory

Description

This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.

Time Frame

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.

Title

Freiburg Mindfulness Inventory

Description

Time Frame

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.

Title

Roland-Morris Disability Questionnaire

Description

Time Frame

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.

Title

Pittsburgh Sleep Quality Index

Description

Time Frame

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.

Title

Cohen Perceived Stress Scale

Description

Time Frame

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.

Title

Positive and Negative Affect Scale

Description

Time Frame

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.

Title

Perceived Intervention Effectiveness

Description

This measure will be assessed with a VAS ("0" = not effective at all; "10"= most effective imaginable) for each intervention session's respective manipulation.

Time Frame

All 12 intervention sessions, MRI 2, and MRI 3 (Visit 3-16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Title

Social Connectedness Scale

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Linares, MSc

Phone

(858) 822-4460

lrlinares@health.ucsd.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Fadel Zeidan, PhD

Phone

(858) 246-2391

fzeidan@ucsd.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fadel Zeidan, PhD

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC San Diego Center for Functional MRI

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Liu, PhD

Phone

858-822-0542

ttliu@ucsd.edu

Facility Name

UC San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fadel Zeidan, PhD

Phone

858-306-3783

zeidanpainlab@ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Zeidan F, Emerson NM, Farris SR, Ray JN, Jung Y, McHaffie JG, Coghill RC. Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia. J Neurosci. 2015 Nov 18;35(46):15307-25. doi: 10.1523/JNEUROSCI.2542-15.2015.

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Zeidan F, Adler-Neal AL, Wells RE, Stagnaro E, May LM, Eisenach JC, McHaffie JG, Coghill RC. Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids. J Neurosci. 2016 Mar 16;36(11):3391-7. doi: 10.1523/JNEUROSCI.4328-15.2016.

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Mindfulness and Chronic Low Back Pain

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