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A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain

(PCORI OPD-1601-33860, Site PI: Garland, Overall PI: Zgierska, $8,430,230, 2017-2022).

One in four US adults have chronic low back pain, which is defined as any type of pain in the low back or radiating down to the legs (sciatica) that lasts for three or more months. Chronic low back pain can make it difficult to do daily activities such as walking, sitting, or climbing stairs. Doctors often cannot cure chronic low back pain, but they may prescribe an opioid medicine to help patients manage their pain.

These medicines can have serious side effects, such as addiction to the medicine, depression, or even death from accidental overdose. Because of these side effects, patients, families, and doctors want to learn about other ways patients can safely manage chronic low back pain and reduce or eliminate the use of opioid medicines.

This randomized controlled effectiveness trial compares two ways to help patients reduce chronic low back pain and improve their quality of life:

  1. Mindfulness meditation helps people train their minds to focus attention in a certain way to cope with and reduce negative reactions to pain.
  2. Cognitive behavioral therapy, a type of psychological therapy, helps people learn how to change their thoughts and feelings about pain and develop new ways to think and act when they are in pain.

The research team is recruiting 766 people with chronic low back pain who currently are taking an opioid medicine. Study outcomes include pain, function, quality of life, and opioid dose. This study will be the largest trial of a mindfulness-based intervention ever conducted in the scientific literature.

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Last Updated: 7/2/19