Status:

COMPLETED

Mindfulness and Chronic Low Back Pain

Lead Sponsor:

University of California, San Diego

Conditions:

Chronic Low Back Pain

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. A te...

Detailed Description

To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP) patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC), subgenual anterio...

Eligibility Criteria

Inclusion

  • Inclusion criteria are:
  • 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. This will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on MRI.
  • Participants must be between the ages of 18-65 years.
  • Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.
  • Participants must have experienced their radicular pain for at least 3 months duration.
  • Participants must be right-handed.
  • Participants must have no prior meditative experience
  • 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 have had back surgery within the last year before their enrollment into the study.
  • Participants must not have had any other sensory or motor deficits that precludes participation in this study.
  • Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis.
  • Participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, BBs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed.
  • Participants must not be claustrophobic.
  • Participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less).
  • Participants must not be pregnant
  • Participants must not be over 275 pounds

Exclusion

    Key Trial Info

    Start Date :

    January 2 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 5 2024

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT03354585

    Start Date

    January 2 2020

    End Date

    February 5 2024

    Last Update

    April 29 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    UC San Diego

    La Jolla, California, United States, 92037

    2

    UC San Diego Center for Functional MRI

    La Jolla, California, United States, 92093