Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Nov 2022
Longer than P75 for not_applicable low-back-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 3, 2026
January 1, 2026
4.4 years
October 31, 2022
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Visual Analog Scale Pain Ratings
At baseline and at post-treatment (8 weeks)
Chronic pain symptoms
At baseline, post-treatment (8 weeks), and 3-month follow-up
Opioid dose
At baseline, post-treatment (8 weeks), and 3-month follow-up
Pain catastrophizing
At baseline, post-treatment (8 weeks), and 3-month follow-up
Self-transcendence
At baseline, post-treatment (8 weeks), and 3-month follow-up
- +2 more secondary outcomes
Other Outcomes (2)
Heart rate variability
At baseline and at post-treatment (8 weeks)
Cue-reactivity
At baseline and at post-treatment (8 weeks)
Study Arms (3)
Mindfulness
EXPERIMENTALA well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
Meditation
EXPERIMENTALA validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
Usual Care
ACTIVE COMPARATORPatients will receive usual medical care for chronic low back pain.
Interventions
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
Eligibility Criteria
You may qualify if:
- \) 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.
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, San Diego
La Jolla, California, 92093, United States
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Garland, PhD
University of Utah
- PRINCIPAL INVESTIGATOR
Fadel Zeidan, PhD
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Dean for Research
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 7, 2022
Study Start
November 30, 2022
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- Data will be made available upon reasonable request with a signed data access agreement.
The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.