Study Results
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Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-01-02
2024-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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mindfulness group
Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught that perceived sensory events are "momentary" and "fleeting" and do not require further evaluation. There will be an emphasis on breath focus and altering one's perspective of discursive sensory events. This intervention has been found to reliably attenuate the subjective experience of pain.
mindfulness training
A well-validated brief mindfulness-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
non-mindfulness group
Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.
non-mindfulness training
A well-validated brief meditation-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
book-listening
Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 6 session intervention is meant to provide the control attention to the facilitator, room setting, social support, conditioning, and the time elapsed during the other respective interventions. We do not expect that this group will demonstrate significant cerebral blood flow changes as a function of the intervention.
book-listening
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
Interventions
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mindfulness training
A well-validated brief mindfulness-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
non-mindfulness training
A well-validated brief meditation-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
book-listening
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Fadel Zeidan
Associate Professor
Principal Investigators
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Fadel Zeidan, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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UC San Diego
La Jolla, California, United States
UC San Diego Center for Functional MRI
La Jolla, California, United States
Countries
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References
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Zeidan F, Emerson NM, Farris SR, Ray JN, Jung Y, McHaffie JG, Coghill RC. Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia. J Neurosci. 2015 Nov 18;35(46):15307-25. doi: 10.1523/JNEUROSCI.2542-15.2015.
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Int J Ther Massage Bodywork. 2015 Sep 1;8(3):16-33. doi: 10.3822/ijtmb.v8i3.295. eCollection 2015 Sep.
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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181814
Identifier Type: -
Identifier Source: org_study_id
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