Mindfulness and Chronic Low Back Pain

STATUS

Recruiting
End date

Oct 2, 2024
participants needed

120
sponsor

University of California, San Diego

Updated on 24 April 2022

See if I qualify

chronic pain

low back pain

radicular pain

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.

Description

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.

Details

Condition	Chronic Low Back Pain
Treatment	Mindfulness Training, Meditation training, Book Listening Control, Meditatin training
Clinical Study Identifier	NCT03354585
Sponsor	University of California, San Diego
Last Modified on	24 April 2022

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Eligibility		Yes	No	Not Sure
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. 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

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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Mindfulness and Chronic Low Back Pain