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A comparative effectiveness randomized controlled trial of mindfulness meditation versus cognitive behavioral therapy for opioid-treated chronic low back pain
Investigator (PI): Zgierska, Aleksandra
Performing Organization (PO): (Current): University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health / (608) 263-4550
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2022
Record Source/Award ID: PCORI/OPD-1601-33860
Funding: Total Award Amount: $8,430,230
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Managing Long-Term Low Back Pain to Improve Health and Reduce Reliance on Opioid Medicines: Comparing Mindfulness Meditation and Cognitive Behavioral Therapy. 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 (the PCORI website) 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 (a) mindfulness meditation helps people train their minds to focus attention in a certain way to cope with and reduce negative reactions to pain; and (b) 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: The study design is a randomized controlled trial. Population. The study population is adults with chronic low back pain who take a daily opioid medicine. Interventions/comparators are (a) mindfulness meditation and (b) cognitive behavioral therapy. Outcomes: Outcomes are (a) primary: reduced pain levels and increased function and (b) secondary: improved quality of life and reduced reliance on opioid medicine. Timeframe: The timeframe is 12-month follow-up on primary outcome.
Abstract Archived: Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families, and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring nonjudgmental and accepting attention to present-moment experiences, such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping reduce opioid use. Early research, including a pilot study by the principal investigator, indicates that MM has great potential to improve health and well-being of patients with opioid-treated CLBP. However, evidence of MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, we have designed a study to address this gap. We propose a clinical trial that will compare the effectiveness of MM with CBT in opioid-treated CLBP. Based on the existing research, we hypothesize that MM training will lead to a larger reduction in pain intensity, an increase in physical function, an improvement in quality of life, and a decrease in daily opioid dose, as compared with CBT training. We also hypothesize that the benefits of MM will be especially notable in adults with worse depressed mood, anxiety, or unhealthy opioid-use behaviors; these adults often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, we will randomly assign 500 adults in Madison, Wisconsin and Boston, Massachusetts, with opioid-treated CLBP, into one of two eight-week treatment groups: an MM group (n=250) that will receive the MM training or a CBT group (n=250) that will receive the CBT training. We will then compare their outcomes over a 12-month period. We will assess the effectiveness of MM versus CBT with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, who include patients with opioid-treated CLBP, their families, and clinicians. As suggested by our patient partners, we will also conduct interviews with participants to gather additional information about the effects of MM and CBT on pain, function, quality of life, and opioid use. Our partners have helped design this study; they will continue their involvement by helping us finalize the study methods, troubleshoot potential challenges, and advise on dissemination of results so that they can meaningfully inform the decisions that clinicians and patients make about therapy choices.

MeSH Terms:
  • Analgesics, Opioid /*therapeutic use
  • Anxiety /complications
  • Chronic Pain /drug therapy
  • /psychology /*therapy
  • Cognitive Behavioral Therapy
  • Comparative Effectiveness Research
  • Depression /complications
  • Humans
  • Low Back Pain /drug therapy
  • /psychology /*therapy
  • Massachusetts
  • Meditation
  • Mindfulness
  • Opioid-Related Disorders /complications
  • Outcome Assessment, Health Care
  • Pain Management
  • Pilot Projects
  • Program Evaluation
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Self Care
  • Wisconsin
Country: United States
State: Wisconsin
Zip Code: 53715
UI: 20164149
CTgovId: NCT03115359
Project Status: Ongoing
Record History: ('2018: Start date changed from 2017 to 2018. 2017: Project extended to 2022.',) ('Project start date corrected to 2017 per PCORI, 2/4/2020',) ('2020: Abstract archived to Abstract Archived 1 field and added new abstract.',)