Chronic, Non-neuropathic Back Pain
Conditions
Brief summary
The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.
Interventions
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
BEHAVIORALSupport Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. age 21-60 years of age 2. English fluency 3. 20/20 vision with corrective lenses 4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment 5. reporting pain ≥3 on 0-10 scale with opioid medication 6. current use of prescription opioids for ≥3 consecutive months 7. ability to understand study procedures and to comply with them for the entire length of the study
Exclusion criteria
1. Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation) 2. psychosis 3. untreated, active suicidality in the past month 4. and severe non-opioid substance use disorder in the past year as assessed with the MINI 5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain 6. pregnancy 7. inability or unwillingness of individual to give written informed consent 8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in endogenous opioid system function in response to pain challenge | Change from week 0 to 8 weeks | PET opioid receptor binding potential from baseline through pain challenge |
| Changes in fMRI activity level during natural reward processing | Change from week 0 to 8 weeks | Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain sensitivity as a measure of volume of hypertonic saline | Change from week 0 to 8 weeks | Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS |
| Self-report affect ratings | Change from week 0 to 8 weeks | — |
| Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use | Change from week 0 to 8 weeks | — |
Countries
United States
Outcome results
None listed