Chronic Low Back Pain and Meditation

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT04034004
• Collaborator: (none)
• Enrollment: 59
• Locations: 2
• Arms: 2
• Actual Duration (Months): 27.4
• Patients Per Site: 29.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 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.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: Sep 9, 2019
• Actual Primary Completion Date: Dec 22, 2021
• Actual Study Completion Date: Dec 22, 2021

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: mental training

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale and Numerical Rating Scale Pain Ratings [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altman Clinical and Translational Research Institute	La Jolla	California	United States	92093
2	UC San Diego Center for Mindfulness	San Diego	California	United States	92122

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: Fadel Zeidan, PhD, UC San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

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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: Jul 26, 2019
• Last Update Posted: Feb 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fadel Zeidan, Assistant Professor, University of California, San Diego: Mindfulness; Opioids; Pain; Naloxone
• Additional relevant MeSH terms: Naloxone

Study Results

No Results Posted as of Feb 7, 2022