Mindfulness and Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354585
• Other study ID #: 181814
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: February 5, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• mindfulness training
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.
• non-mindfulness training
A well-validated brief meditation-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
• book-listening
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California
United States	UC San Diego Center for Functional MRI	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (32)

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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. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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.
Primary	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.	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	Visual Analog Scale Pain Ratings	Changes in 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	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.
Secondary	Numerical Pain Ratings	Changes in numerical pain ratings (NRS) 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	Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Secondary	Blood Oxygen Dependent Signaling	Changes in BOLD fMRIacquired during noxious heat stimulation during rest and manipulations 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	Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	Brief Pain Inventory	This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.