Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
Behavioral: Meditation
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
Other: Usual care
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
|
| Experimental: Meditation A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
Behavioral: Meditation
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
Other: Usual care
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
|
| Active Comparator: Usual Care Patients will receive usual medical care for chronic low back pain. |
Other: Usual care
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
- 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.
Other Outcome Measures
- Heart rate variability [At baseline and at post-treatment (8 weeks)]
Changes in heart rate variability (HRV) measured with a 3-lead ECG.
- Cue-reactivity [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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah | United States | 84108 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Eric Garland, PhD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB_00133405