Chronic, Non-neuropathic Back PainNCT02935465
Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Chronic, Non-neuropathic Back Pain, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic, Non-neuropathic Back Pain
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
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.
- Conditions
- Chronic, Non-neuropathic Back Pain
- Being tested
- Mindfulness-Oriented Recovery Enhancement (MORE), Support Group
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery Enhancement (MORE)Behavioural
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.
Support GroupBehavioural
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| Support Group | Active comparator | Participants will attend a support group weekly for eight weeks. Receives: Behavioral: Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endogenous opioid system function in response to pain challenge
PET opioid receptor binding potential from baseline through pain challenge
Measured: Change from week 0 to 8 weeks
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.
Measured: Change from week 0 to 8 weeks
Secondary outcomes (3)
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
Measured: Change from week 0 to 8 weeks
Self-report affect ratings
Measured: Change from week 0 to 8 weeks
Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use
Measured: Change from week 0 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Synthesis of the chemical precursor for the neuroimaging radiotracer could not be produced in a stable fashion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic, Non-neuropathic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Eric Garland, University of Utah
- Investigators
- Eric L Garland, PhD, Principal investigator, The University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935465
- Sponsor's protocol ID
- 00093561
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT02935465
- Acronym / sponsor ID
- 00093561
- Conditions
- Chronic, Non-neuropathic Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Synthesis of the chemical precursor for the neuroimaging radiotracer could not be produced in a stable fashion.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
| Support Group | Active comparator | Behavioral: Support GroupParticipants will attend a support group weekly for eight weeks. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement (MORE)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. | Behavioural | Mindfulness-Oriented Recovery Enhancement |
| Support GroupA conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist. | Behavioural | Support Group |
Primary outcome
Changes in endogenous opioid system function in response to pain challenge
Time frame: 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
Time frame: 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.
3 secondary outcomes
Pain sensitivity as a measure of volume of hypertonic saline
Time frame: Change from week 0 to 8 weeks
Self-report affect ratings
Time frame: Change from week 0 to 8 weeks
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
Results and safety
The study was stopped early (reason given: Synthesis of the chemical precursor for the neuroimaging radiotracer could not be produced in a stable fashion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L Garland, PhD principal investigator
The University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Chronic, Non-neuropathic Back Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Synthesis of the chemical precursor for the neuroimaging radiotracer could not be produced in a stable fashion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in endogenous opioid system function in response to pain challenge (time frame: Change from week 0 to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.