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NCT Number: NCT05607381

Neural Mechanisms of Meditation for Opioid-Treated 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

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About this study

The trial is powered to detect an effect on the primary outcome with 150 participants with complete pre-post data; additional participants are enrolled to account for approximately 25% attrition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Meditation

Behavioral

Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.

Usual Care

Other

Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

Primary outcomes

  1. Blood oxygenation level dependent (BOLD) signaling

    Time frame: At baseline and at post-treatment (8 weeks)

    Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.

Secondary outcomes

  1. Visual Analog Scale Pain Ratings

    Time frame: At baseline and at post-treatment (8 weeks)

    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".

  2. Chronic pain symptoms

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)

  3. Opioid dose

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    Opioid dose as assessed with Timeline Followback Procedure

  4. Pain catastrophizing

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    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.

  5. Self-transcendence

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)

  6. Mindful reinterpretation of pain sensations

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    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)

  7. Trait mindfulness

    Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up

    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.

Other outcomes

  1. Heart rate variability

    Time frame: At baseline and at post-treatment (8 weeks)

    Changes in heart rate variability (HRV) measured with a 3-lead ECG.

  2. Cue-reactivity

    Time frame: At baseline and at post-treatment (8 weeks)

    Cue-reactivity as evidenced by blood oxygenation level dependent (BOLD) signaling and cue-reactivity ratings during cue-exposure

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Garland, PhD

CONTACT

[email protected]

858-822-4092

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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