Summary

for people ages 18-65 (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Fadel Zeidan

Description

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 technique called functional magnetic resonance imaging (fMRI) allows scientists to determine which parts of the brain are active during a particular task. This study will provide new information about how mindfulness affects the brain.

Official Title

Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief

Details

You have been asked to participate in this study because you are interested in learning mindfulness and have been diagnosed with chronic low-back pain. Your participation is voluntary. We will randomly assign 40 subjects to each group for the initiation of the final phase of the study. Randomization means that you have a one in two chance of being assigned to the mindfulness meditation training or book-listening control intervention. Your assignment is based on chance rather than a medical decision made by the researchers.

Keywords

Chronic Low Back Pain Mindfulness fMRI Pain Low Back Radicular Back Pain Low Back Pain Meditation training Meditatin training

Eligibility

You can join if…

Open to people ages 18-65

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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Center for Functional MRI not yet accepting patients
    La Jolla California 92093 United States
  • UC San Diego Center for Mindfulness not yet accepting patients
    San Diego California 92122 United States

Lead Scientist

  • Fadel Zeidan
    Assistant Professor, Anesthesiology. Authored (or co-authored) 27 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03354585
Study Type
Interventional
Last Updated