Low Back PainNCT05607381
Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
A study testing Meditation in people with Low Back Pain and Opioid Use, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Opioid Use
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Rachel Brewers, 619-363-6407, rbrewers@health.ucsd.edu
Eric Garland, PhD
- Active, not recruiting
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84108
About this study
Official title: Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain, Opioid Use
- Being tested
- Meditation, Usual care
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
Usual careOther
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. Receives: Behavioral: Meditation; Other: Usual care |
| Meditation | Experimental | A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. Receives: Behavioral: Meditation; Other: Usual care |
| Usual Care | Active comparator | Patients will receive usual medical care for chronic low back pain. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) signaling
Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.
Measured: At baseline and at post-treatment (8 weeks)
Secondary outcomes (7)
Visual Analog Scale Pain Ratings
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".
Measured: At baseline and at post-treatment (8 weeks)
Chronic pain symptoms
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Opioid dose
Opioid dose as assessed with Timeline Followback Procedure
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Pain catastrophizing
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.
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Self-transcendence
Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Mindful reinterpretation of pain sensations
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)
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Trait mindfulness
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.
Measured: At baseline, post-treatment (8 weeks), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start30 Nov 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of Utah
- Investigators
- Eric Garland, PhD, Principal investigator, University of UtahFadel Zeidan, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607381
- Sponsor's protocol ID
- IRB_00133405
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05607381
- Acronym / sponsor ID
- IRB_00133405
- Conditions
- Low Back Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Nov 2022 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Meditation, Other: Usual careA well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
| Meditation | Experimental | Behavioral: Meditation, Other: Usual careA validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
| Usual Care | Active comparator | Other: Usual carePatients will receive usual medical care for chronic low back pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| MeditationParticipants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues. | Behavioural | Meditation, Mindfulness |
| Usual careParticipants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.). | Other | Meditation, Mindfulness, Usual Care |
Primary outcome
Blood oxygenation level dependent (BOLD) signaling
Time frame: At baseline and at post-treatment (8 weeks)
Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.
7 secondary outcomes
Visual Analog Scale Pain Ratings
Time frame: At baseline and at post-treatment (8 weeks)
Chronic pain symptoms
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Opioid dose
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Pain catastrophizing
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Self-transcendence
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Mindful reinterpretation of pain sensations
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Trait mindfulness
Time frame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
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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.
Eric Garland, PhD principal investigator
University of Utah
Fadel Zeidan, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Low Back Pain and Opioid Use, run by University of Utah at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Garland, PhD (858-822-4092, eric.garland@socwk.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygenation level dependent (BOLD) signaling (time frame: At baseline and at post-treatment (8 weeks)). 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 27 Jul 2026.