Managing Long-Term Low Back Pain to Improve Health and Reduce Reliance on Opioid Medicines: Comparing Mindfulness Meditation and Cognitive Behavioral Therapy -- Strategies To Assist with Management of Pain (STAMP)

PCORI has identified opioid use for chronic pain as an important research topic. Patients, clinicians, and others want to learn: How can patients lower their use of opioid medications while managing chronic pain, or eliminate use of these drugs altogether? To help answer this question, PCORI launched a funding initiative in 2016 on Clinical Strategies for Managing and Reducing Long Term Opioid Use for Chronic Pain. This research project is one of the studies PCORI awarded as part of this program. This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? 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 study compares two ways to help patients reduce chronic low back pain and improve their quality of life: Mindfulness meditation helps people train their minds to focus attention in a certain way to cope with and reduce negative reactions to pain. 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. Who can this research help? This research can help people who have chronic low back pain, their families, and their doctors make choices about how to treat chronic low back pain. What is the research team doing? The research team is recruiting 766 people with chronic low back pain who currently are taking an opioid medicine. The researchers are assigning participants by chance to one of two groups. The first group receives training in mindfulness meditation. The second group receives training in cognitive behavioral therapy. Participants learn these techniques during two-hour weekly group sessions for eight weeks and practice the techniques at home. The research team is following people in both groups for a year to see which group reports less pain; better ability to perform basic functions such as walking, climbing stairs, and being physically active; better quality of life; and taking less opioid medicine. Researchers also are interviewing people in the study to learn more about how the treatments affect their chronic low back pain. The research team includes patients with chronic low back pain, their family members, clinicians, and researchers. Patients on the research team are helping the researchers decide what to ask the study participants about their experiences. Research methods at a glance Design Element Description Study Design Randomized controlled trial Population Adults with chronic low back pain who take a daily opioid medicine Interventions/ Comparators Mindfulness meditation Cognitive behavioral therapy Outcomes Primary: reduced pain levels and increased function Secondary: improved quality of life, reduced reliance on opioid medicine Timeframe 12-month follow-up for primary outcome