Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Opioid Use
• Intervention / Treatment: Behavioral: Meditation; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Garland, PhD; Phone Number: 858-822-4092; Email: eric.garland@socwk.utah.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Principal Investigator: Fadel Zeidan, PhD
      • Principal Investigator: Eric Garland, PhD
      • Contact: Rachel Brewers; Phone Number: 619-363-6407; Email: rbrewers@health.ucsd.edu
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Active, not recruiting
      • Center on Mindfulness and Integrative Health Intervention Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.

Exclusion Criteria:

1) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.	Behavioral: Meditation; Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.; Other: Usual care; Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
Experimental: Meditation; A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.	Behavioral: Meditation; Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.; Other: Usual care; Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
Active Comparator: Usual Care; Patients will receive usual medical care for chronic low back pain.	Other: Usual care; Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygenation level dependent (BOLD) signaling	Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.	At baseline and at post-treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Pain Ratings	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".	At baseline and at post-treatment (8 weeks)
Chronic pain symptoms	Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Opioid dose	Opioid dose as assessed with Timeline Followback Procedure	At baseline, post-treatment (8 weeks), and 3-month follow-up
Pain catastrophizing	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.	At baseline, post-treatment (8 weeks), and 3-month follow-up
Self-transcendence	Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Mindful reinterpretation of pain sensations	Mindful reinterpretation of pain sensations measured by the Mindful Reinterpretation of Pain Sensations Scale, with higher scores indicating higher reinterpretation of pain sensations (min 0, max 45)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Trait mindfulness	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.	At baseline, post-treatment (8 weeks), and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	Changes in heart rate variability (HRV) measured with a 3-lead ECG.	At baseline and at post-treatment (8 weeks)
Cue-reactivity	Cue-reactivity as evidenced by blood oxygenation level dependent (BOLD) signaling and cue-reactivity ratings during cue-exposure	At baseline and at post-treatment (8 weeks)

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Eric Garland, PhD, University of Utah; Principal Investigator: Fadel Zeidan, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy; Meditation
• Other Study ID Numbers: IRB_00133405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
• IPD Sharing Time Frame: Data will become available after the publication of the main study findings from the final data set. Data will be made permanently available.
• IPD Sharing Access Criteria: Data will be made available upon reasonable request with a signed data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No