Regenstrief Institute and the U.S. Department of Veterans Affairs will co-lead a $21 million national study to find the best approach to manage chronic low back pain. The VA is directly funding the 20-site trail. Lead clinical investigators are Matthew J. Blair, MD, MS (Regenstrief Institute) and David Clark, MD, PhD, a pain specialist (VA Palo Alto Health Care System, Stanford).
Low back pain is the most disabling chronic condition around the globe. The National Institute of Neurological Disorders and Stroke reports 80% of adults experience low back pain at some point during their life. Approximately 20% of those affected by acute back pain develop chronic low back pain—defined as pain that lasts 12 weeks or more. A challenging condition often those afflicted end up in pain clinics receiving steroid injections and opioids for pain management. Many an opioid addict started out with back pain. The opioid epidemic has ravaged America.
The Study (SCEPTER Trial)
Called the Sequential and Comparative Evaluation of Pain Treatment (SCEPTER) trial, the study investigators have designed a two-step sequential randomized pragmatic clinical trial. Unlike explanatory trials, pragmatic trials are designed to test the effectiveness of the intervention in a broad routine clinical practice.
Step one: the investigators will divide the participants randomly among three different treatments. Some of the patients will be assigned to a web-based pain self-management program. Other patients will receive “enhanced physical therapy,” which will include some of the strategies from the web-based intervention combined with a physical therapist-directed exercise program including face to face appointments. The third group will receive usual standard of care.
Step Two: the investigators will also compare cognitive behavioral therapy, chiropractic care and a yoga-based intervention. Participants will be given the option to be randomized again, and if they prefer not to do one of those therapies, they will be allowed to opt out of that group and be randomized to one of the other two groups.
The study has been designed to incorporate patient preferences which can have considerable benefit—which is the primary goal.
Low back pain is the beginning of an incredibly vicious downward spiral for millions of people but especially in America where opioids were and are used to help manage this insidious problem. In other countries it is more difficult to obtain opioids. The healthcare system is not designed to make back patients better—it isn’t a health care system but rather a sick care system. My father had low back problems due to herniated disc. He managed the pain with opioids and never was able to not depend on them. For much of my life I saw the direct correlation between back pain, opioids and the consequences of that approach—all the way till his death. I too have been afflicted with low back troubles—a result of genetics and a lot of sports injuries. I was headed down the same path but I couldn’t—life is too short. I took control of my health care. A doctor referred me to a truly gifted individual who has made my pain go away nearly all the time. A combination of Pilates and exercise physiology, this program and practitioner is tailored to my specific body type, back and spine issue, etc. The net takeaway—I have gone from living in a steady state of low back pain to practically no pain—with no drugs. There is hope but the first step is to be open to a whole new world of knowledge. Much of what we learn about how to treat back problems, for example, is incorrect.
Erik Groessl, PhD
Jennifer Murphy, PhD
Diana Higgins, PhD
Paul Daughtery, DC
Ilana Belitskaya-Levy, PhD
Mei-Chiung Shih, PhD