Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain (NCT05607381) | Clinical Trial Compass
RecruitingNot Applicable
Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
United States188 participantsStarted 2022-11-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying brain activity using BOLD signaling in MRI scans — what does that actually involve physically, and are there any risks or discomforts I should know about before considering it?
2Since this trial is listed as 'Phase NA,' it sounds like it's focused on understanding how meditation affects the brain rather than testing a treatment — does that mean I wouldn't necessarily get a new therapy, and how might that affect my ongoing opioid management for back pain?
3The study is looking at meditation as an approach for people already on opioids for chronic low back pain — given my current treatment plan, would participating in this kind of study interfere with or complement what I'm already doing?
4Are there standard non-opioid or behavioral treatments for chronic low back pain that I should consider trying first, rather than joining a research study that may primarily be gathering data about brain responses?
5What would the time commitment and travel burden actually look like for me if I were to discuss joining this trial — for example, how many MRI sessions or meditation sessions might be involved?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.