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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mindfulness

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

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type OTHER

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

Meditation

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

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type OTHER

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

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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Meditation

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

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No