HERSHEY, Pa. — The list of treatments for low back pain is endless, but few offer relief for the one in four Americans who suffer from this persistent pain and leading cause of disability globally. More than 80% of those with chronic low back pain wished there were better treatment options. Yet, without sufficient pain relief, many people need to take opioids, which can be addictive.
The good news? A multi-institutional team, led by researchers from the Penn State College of Medicine and the University of Wisconsin-Madison, found that eight weeks of either mindfulness or cognitive behavioral therapy (CBT) training led to meaningful improvements among adults with chronic low back pain that’s currently treated with opioids and had not responded to prior treatments. These behavioral therapies helped improve physical function and quality of life and reduce pain and opioid dose in a randomized clinical trial. The benefits persisted for up to 12 months.
The findings were published today (April 7) in JAMA Network Open. This is the largest trial to date comparing mindfulness with CBT as treatments for opioid-treated chronic pain and the research team followed up with participants over a longer time period than many previous trials of mindfulness.
“Both mindfulness and cognitive behavioral therapy were shown to be safe, effective treatments, providing lasting benefits for people with opioid-treated chronic back pain,” said Aleksandra Zgierska, Jeanne L. and Thomas L. Leaman, MD, endowed professor and vice chair of research of family and community medicine and professor of anesthesiology and perioperative medicine and of public health sciences at the Penn State College of Medicine, who led the study. “These evidence-based behavioral therapies should be standard of care available to our patients.”
Pain is multifaceted, especially chronic pain that can last for months or years. Chronic low back pain is the most common form of chronic non-cancer pain that’s treated with opioids. Previous research has shown that adults with chronic pain may benefit from behavioral therapies, which can help people change their thoughts about and relationship to pain, but it’s been understudied, the researchers explained. Studies on behavioral therapies were generally small in size and evaluated benefits over the short-term.
“People think of chronic pain as a physical condition that requires a physical intervention,” said Eric Garland, endowed professor in health sciences and professor of psychology at the University of California, San Diego, and senior author of the study.
The research team set out to evaluate the effectiveness of mindfulness compared to CBT as treatments for chronic opioid-treated low back pain and their long-term effects. CBT is considered the standard psychotherapy for chronic pain, but its long-term benefits haven’t been well studied. To date, only 17 studies have evaluated mindfulness for chronic low-back pain and three studies have compared mindfulness and CBT.
This study was planned in partnership with an advisory panel composed of clinicians and representatives of community and advocacy organizations that work with people with chronic pain as well as adults with opioid-treated chronic low back pain and their caregivers. The panel’s feedback, included throughout the study, helped the researchers design and implement the study and better translate the study’s results to be meaningful and useful to patients and clinicians.
The team enrolled 770 adults to participate in a randomized clinical trial conducted in three sites — Madison, Wisconsin; Boston, Massachusetts; and Salt Lake City, Utah. Participants, on average, experienced moderate-to-severe pain, functional limitations, compromised quality of life and numerous prior treatments for their chronic low-back pain and were treated with daily opioid medications for at least three months.
“The people in this study had quite severe back pain that interfered with their life and was bad enough to need opioid medication. Usually, in that condition, people don’t really get better over time on their own,” said Bruce Barrett, professor of family medicine and community health at the University of Wisconsin-Madison and co-lead of the study.
Participants were then assigned to either receive mindfulness-based therapy or CBT, which were conducted in therapist-led, two-hour group sessions for eight weeks. The mindfulness group learned to notice the sensations they experienced, giving them more control over how they related and respond to the pain and other symptoms. The CBT group learned coping skills and strategies to change their negative thought patterns.
Participants were instructed to practice on their own for 30 minutes a day, six days a week during the 12-month study and to continue with their routine care. They were not instructed to reduce their opioid dosage. They reported on their pain level, ability to do daily activities, mental and physical health-related quality of life and daily opioid medication use at the start of the study and after three, six, nine and 12 months.
At the end of the study, participants in both groups reported significant and long-lasting benefits including reductions in pain and daily opioid dose. They also reported increased function and health-related quality of life through 12 months. Both mindfulness and CBT tools were shown that they could be effective and used safely over the long-term, the researchers said.
“The goal of pain management is to improve quality of life, increase function and reduce the sense of suffering. The study’s interventions likely helped reduce the participants’ sense of suffering, which probably allowed them to function a whole lot better,” said Penney Cowan, founder of the American Chronic Pain Association and co-author and advisor on the study. “People can live with pain, but they need to know how to do it. This study provides a sense of hope. It says you can do this and help yourself to a better quality of life.”
The research team explained that people living with chronic pain assemble a toolkit filled with different self-coping and self-care methods to manage their pain. They can use these tools at different times and in different ways.
“Mindfulness and CBT are other tools that you can add to your toolbox to increase your capacity to cope and live a meaningful life,” said Christin Veasley, founder of the Chronic Pain Research Alliance and co-author and advisor on the study. “What's important about the types of therapies, like the ones evaluated in this study, is that they can be used broadly across all pain conditions and all pain severities.”
For example, while participants were told to continue their usual treatment, including pain medication as advised by their usual clinicians, opioid dosage decreased in both groups through 12 months following the intervention. Zgierska explained that participants learned skills, like taking a mindful breath before taking medication. The improvements, the research team said, were the byproduct of people implementing these tools, learning to better cope with pain and deciding to decrease their opioid use on their own.
“These therapies aren’t a total cure, but they teach people how to develop the inner resources they need to cope with chronic pain and to live a better life,” Garland said. “Mindfulness is a self-regulated tool that comes from within, unlike surgery or medication where something is being done to you from the outside. By learning these techniques, patients continue to experience lasting benefit.”
Other Penn State College of Medicine authors include Vernon Chinchilli, distinguished professor; Chan Shen, professor; Wen-Jan Tuan, assistant professor; Robert Lennon, who was associate professor during the time of the research; and statisticians Yuxin Liu and Huamei Dong.
Other authors include Robert Edwards and Robert Jamison from Harvard Medical School, Brigham and Women’s Hospital; Cindy Burzinski, Mary Henningfield, Alyssa Turnquist, Nalini Sehgal and Anthony Schiefelbein from the University of Wisconsin-Madison; Yoshio Nakamura from the University of Utah School of Medicine; and Elizabeth Jacobs from the University of California, Riverside, School of Medicine.
Funding from the Patient-Centered Outcomes Research Institute (PCORI) supported this work. Funding and institutional support from the University of Wisconsin-Madison School of Medicine and Public Health; Brigham and Women’s Hospital, Harvard Medical School; University of Utah College of Social Work; and the Penn State College of Medicine also supported this work.