Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 188
- Locations
- 2
- Primary Endpoint
- Blood oxygenation level dependent (BOLD) signaling
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mindfulness
A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.
Intervention: Meditation (Behavioral)
Mindfulness
A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.
Intervention: Usual care (Other)
Meditation
A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.
Intervention: Meditation (Behavioral)
Meditation
A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.
Intervention: Usual care (Other)
Usual Care
Patients will receive usual medical care for chronic low back pain.
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
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
- 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)
- 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)
- Mindful reinterpretation of pain sensations(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Trait mindfulness(At baseline, post-treatment (8 weeks), and 3-month follow-up)
Investigators
Eric Garland
Associate Dean for Research
University of Utah