Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Meditation

Usual care

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center on Mindfulness and Integrative Health Intervention DevelopmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness

Meditation

Usual Care

Arm Description

A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.

A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.

Patients will receive usual medical care for chronic low back pain.

Outcomes

Primary Outcome Measures

Blood oxygenation level dependent (BOLD) signaling

Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.

Secondary Outcome Measures

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".

Chronic pain symptoms

Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)

Opioid dose

Opioid dose as assessed with Timeline Followback Procedure

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.

Self-transcendence

Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)

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)

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.

Full Information

NCT ID

NCT05607381

First Posted

October 31, 2022

Last Updated

March 22, 2023

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT05607381

Brief Title

Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

Official Title

Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2022 (Actual)

Primary Completion Date

April 2027 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Opioid Use

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness

Arm Type

Experimental

Arm Description

A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.

Arm Title

Meditation

Arm Type

Experimental

Arm Description

A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain.

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Patients will receive usual medical care for chronic low back pain.

Intervention Type

Behavioral

Intervention Name(s)

Meditation

Intervention Description

Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

Primary Outcome Measure Information:

Title

Blood oxygenation level dependent (BOLD) signaling

Description

Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.

Time Frame

At baseline and at post-treatment (8 weeks)

Secondary Outcome Measure Information:

Title

Visual Analog Scale Pain Ratings

Description

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".

Time Frame

At baseline and at post-treatment (8 weeks)

Title

Chronic pain symptoms

Description

Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)

Time Frame