Back to resultsEffects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
Primary Purpose
Chronic, Non-neuropathic Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement (MORE)
Support Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic, Non-neuropathic Back Pain
Eligibility Criteria
Inclusion Criteria:
- age 21-60 years of age
- English fluency
- 20/20 vision with corrective lenses
- current chronic, non-neuropathic back pain diagnosis determined by physician assessment
- reporting pain ≥3 on 0-10 scale with opioid medication
- current use of prescription opioids for ≥3 consecutive months
- ability to understand study procedures and to comply with them for the entire length of the study
Exclusion Criteria:
- Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
- psychosis
- untreated, active suicidality in the past month
- and severe non-opioid substance use disorder in the past year as assessed with the MINI
- clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
- pregnancy
- inability or unwillingness of individual to give written informed consent
- physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Sites / Locations
- College of Social Work
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Oriented Recovery Enhancement
Support Group
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Participants will attend a support group weekly for eight weeks.
Outcomes
Primary Outcome Measures
Changes in endogenous opioid system function in response to pain challenge
PET opioid receptor binding potential from baseline through pain challenge
Changes in fMRI activity level during natural reward processing
Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
Secondary Outcome Measures
Pain sensitivity as a measure of volume of hypertonic saline
Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS
Self-report affect ratings
Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use
Full Information
NCT ID
NCT02935465
First Posted
October 11, 2016
Last Updated
March 4, 2020
Sponsor
University of Utah
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT02935465
Brief Title
Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
Official Title
Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Synthesis of the chemical precursor for the neuroimaging radiotracer could not be produced in a stable fashion.
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic, Non-neuropathic Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement
Arm Type
Experimental
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Arm Title
Support Group
Arm Type
Active Comparator
Arm Description
Participants will attend a support group weekly for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement (MORE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Support Group
Intervention Description
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Primary Outcome Measure Information:
Title
Changes in endogenous opioid system function in response to pain challenge
Description
PET opioid receptor binding potential from baseline through pain challenge
Time Frame
Change from week 0 to 8 weeks
Title
Changes in fMRI activity level during natural reward processing
Description
Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
Time Frame
Change from week 0 to 8 weeks
Secondary Outcome Measure Information:
Title
Pain sensitivity as a measure of volume of hypertonic saline
Description
Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS
Time Frame
Change from week 0 to 8 weeks
Title
Self-report affect ratings
Time Frame
Change from week 0 to 8 weeks
Title
Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use
Time Frame
Change from week 0 to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 21-60 years of age
English fluency
20/20 vision with corrective lenses
current chronic, non-neuropathic back pain diagnosis determined by physician assessment
reporting pain ≥3 on 0-10 scale with opioid medication
current use of prescription opioids for ≥3 consecutive months
ability to understand study procedures and to comply with them for the entire length of the study
Exclusion Criteria:
Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
psychosis
untreated, active suicidality in the past month
and severe non-opioid substance use disorder in the past year as assessed with the MINI
clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
pregnancy
inability or unwillingness of individual to give written informed consent
physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Garland, PhD
Organizational Affiliation
The University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Social Work
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
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