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

Not Applicable

Recruiting

• Conditions: Low Back Pain; Opioid Use

• Registration Number: NCT05607381
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-07
• Study Start: 2022-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-04-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain catastrophizing	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.
Self-transcendence	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)
Visual Analog Scale Pain Ratings	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".
Chronic pain symptoms	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)
Opioid dose	At baseline, post-treatment (8 weeks), and 3-month follow-up	Opioid dose as assessed with Timeline Followback Procedure
Mindful reinterpretation of pain sensations	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)
Trait mindfulness	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.

Trial Locations

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development; 🇺🇸 Salt Lake City, Utah, United States