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Chronic Low Back Pain and Meditation

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ClinicalTrials.gov Identifier: NCT04034004
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Fadel Zeidan, University of California, San Diego

Brief Summary:
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Mindfulness Drug: Naloxone Other: Saline Behavioral: Meditation Early Phase 1

Detailed Description:
The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Only the study physician, research coordinator, and research pharmacist will be aware of drug assignments. Research staff (nurses; research technicians) and the PI will be blinded to drug assignment.
Primary Purpose: Basic Science
Official Title: The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : July 30, 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxone

Arm Intervention/treatment
Experimental: Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Behavioral: Mindfulness
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Other Name: mental training

Drug: Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.

Other: Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.

Behavioral: Meditation
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Other Name: mental training

Experimental: meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Behavioral: Mindfulness
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Other Name: mental training

Drug: Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.

Other: Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.

Behavioral: Meditation
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Other Name: mental training




Primary Outcome Measures :
  1. Visual Analog Scale and Numerical Rating Scale Pain Ratings [ Time Frame: Up to 8 weeks. This will be done at each experimental session where noxious stimulation will be adminstered. Visit 1, 6 and 7. ]
    Pain ratings (VAS pain intensity, VAS unpleasantness, and numerical pain ratings) will be assessed in response to the straight leg raise test and exploratory outcomes include those corresponding to "heat induced pain ratings" (i.e. thermal stimulation), and lying supine. 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 pain.


Secondary Outcome Measures :
  1. Five Facet Mindfulness Questionnaire [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  2. Profile of Mood States Form [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  3. Patients' Global Impression of Change [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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 "1 = no change" to "7 = a great deal better, and a considerable improvement that has made all the difference." Higher ratings indicate greater impressions of change.

  4. Pain Self Efficacy Questionnaire [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  5. Patient-Reported Outcomes Measurement Information System 29-Item Profile [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10). High scores represent more of the domain being measured. Thus, on symptom-oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function- oriented domains (physical functioning and social role) higher scores represent better functioning. For example, a high sleep disturbance score indicates high levels of sleep disturbance; a high physical functioning score indicates better physical function.

  6. Patient-Reported Outcomes Measurement Information System Pain Behavior Measure [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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. Minimum score of five means less suffering and maximum score of 25 means more suffering from pain. Scoring for this measure is item-content dependent. The questions are ranked on a 5-point Likert scale.

  7. Patient-Reported Outcomes Measurement Information System Pain Quality Measure [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  8. Chronic Pain Acceptance Questionnaire [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  9. State Anxiety Inventory [ Time Frame: Up to 8 weeks. Visits 1-7. ]
    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.

  10. Brief Pain Inventory [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    This is an 8-item assessment widely used to measure clinical pain. A numeric value between 0 (No pain/Does Not Interfere) and 10 (Pain as bad as you can imagine/Completely Interferes) is provided in response to each statement. Higher scores reflect a higher severity rating of pain.

  11. Short Form 12 Health Survey [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  12. Pain Catastrophizing Scale [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  13. Beck Depression Inventory [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  14. Freiburg Mindfulness Inventory [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  15. Roland-Morris Disability Questionnaire [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  16. Pittsburgh Sleep Quality Index [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  17. Cohen Perceived Stress Scale [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    The Cohen Perceived Stress Scale(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.

  18. Perceived Intervention Effectiveness [ Time Frame: Up to 8 weeks. Visits 2-7. ]
    This measure will be assessed with a VAS ("0" = not effective at all; "10"= most effective imaginable) for each intervention session's respective manipulation.

  19. Social Connectedness Scale [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    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.

  20. Multidimensional Assessment of Interoceptive Awareness [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    This is a 32-item multidimensional instrument that includes 8 scales ranging from 3 to 7 items each. The scales are noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting.

  21. Nondual Awareness Dimensional Assessment [ Time Frame: Up to 8 weeks. Visit 1, 6 and 7. ]
    This is a 13-item standardized instrument capable of facilitating quantitative investigation of nondual awareness using two dimensions: bliss and self-transcendence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Participants must be between 18 and 65 years of age
  • Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
  • Participants must have experienced their chronic low back pain for at least 3 months
  • Participants must have no prior meditative experience
  • Participants must be straight leg raise test positive

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 be taking opioids
  • Participants must not be pregnant or nursing mothers
  • Participants must have not had back surgery within the last year before their enrollment into the study
  • Participants must have not had any other sensory or motor deficits that preclude participation in this study
  • Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
  • Participants must not have any known allergies to naloxone or similar drugs
  • Participants must not have a history of syncope and/or fear of needles/blood

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034004


Contacts
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Contact: Fadel Zeidan, PhD (858) 246-2391 fzeidan@ucsd.edu
Contact: Julia Birenbaum, BA (858) 246-2028 ext 62028 jbirenbaum@ucsd.edu

Locations
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United States, California
Altman Clinical and Translational Research Institute Recruiting
La Jolla, California, United States, 92093
Contact: Fadel Zeidan, PhD    858-246-2028 ext 62028    zeidanlab@ucsd.edu   
Contact: Julia Birenbaum, BA    858-246-2028 ext 62028    jbirenbaum@ucsd.edu   
UC San Diego Center for Mindfulness Recruiting
San Diego, California, United States, 92122
Contact: Fadel Zeidan, PhD    858-246-2028 ext 62028    zeidanlab@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Fadel Zeidan, PhD UC San Diego
Publications:
Institute of Medicine (US) Committee on Advancing Pain Research C, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington D.C: National Academies Press, 2011.

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Responsible Party: Fadel Zeidan, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04034004    
Other Study ID Numbers: 190709
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fadel Zeidan, University of California, San Diego:
Mindfulness
Opioids
Pain
Naloxone
Additional relevant MeSH terms:
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Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents