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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1
UC San Diego
La Jolla, California, United States, 92037
2
UC San Diego Center for Functional MRI
La Jolla, California, United States, 92093