Low Back Pain, Opioid Use
Conditions
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.
Interventions
BEHAVIORALMeditation
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
OTHERUsual care
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTEric Garland, PhD
PRINCIPAL_INVESTIGATOREric Garland, PhD
University of Utah
PRINCIPAL_INVESTIGATORFadel Zeidan, PhD
University of California, San Diego
Outcome results
None listed