Chronic Low Back Pain and Meditation

University of California San Diego

Status and phase: Completed; Early Phase 1

Conditions: Pain

Treatments: Drug: Naloxone; Other: Saline; Behavioral: Meditation; Behavioral: Mindfulness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04034004

190709

R21AT010352 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

Full description

The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
• Participants must be between 18 and 65 years of age
• Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
• Participants must have experienced their chronic low back pain for at least 3 months
• Participants must have no prior meditative experience
• Participants must be straight leg raise test positive

Exclusion criteria

• Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
• Participants must not be taking opioids
• Participants must not be pregnant or nursing mothers
• Participants must have not had back surgery within the last year before their enrollment into the study
• Participants must have not had any other sensory or motor deficits that preclude participation in this study
• Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
• Participants must not have any known allergies to naloxone or similar drugs
• Participants must not have a history of syncope and/or fear of needles/blood

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

Meditation

Experimental group

Description:

Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.

Treatment:

Behavioral: Meditation

Other: Saline

Behavioral: Mindfulness

Drug: Naloxone

meditation

Experimental group

Description:

Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.

Treatment:

Behavioral: Meditation

Other: Saline

Behavioral: Mindfulness

Drug: Naloxone