Mindfulness and Chronic Low Back Pain

University of California San Diego

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Behavioral: book-listening; Behavioral: non-mindfulness training; Behavioral: mindfulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT03354585

181814

Details and patient eligibility

About

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.

Full 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 anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). Each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

mindfulness group

Experimental group

Description:

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.

Treatment:

Behavioral: mindfulness training

non-mindfulness group

Sham Comparator group

Description:

Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.

Treatment:

Behavioral: non-mindfulness training

book-listening

Active Comparator group

Description:

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.

Treatment:

Behavioral: book-listening