Mindfulness and Chronic Low Back Pain (NCT03354585) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness and Chronic Low Back Pain
United States120 participantsStarted 2020-01-02
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
Timeframe: There will be up to 2 fMRI sessions (Visit 2, and 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.