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

Utah System of Higher Education (USHE)

Status

Enrolling

Conditions

Opioid Use

Low Back Pain

Treatments

Other: Usual care

Behavioral: Meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT05607381

IRB_00133405

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 3 patient groups

Mindfulness

Experimental group

Description:

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

Treatment:

Behavioral: Meditation

Other: Usual care

Meditation

Experimental group

Description:

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

Treatment:

Behavioral: Meditation

Other: Usual care

Usual Care

Active Comparator group