Functional Cognitive Therapy for Chronic Low Back Pain: A Phase 3 Randomized Controlled Trial Demonstrating Significant and Sustained Reductions in Pain and Disability

Lower back pain is a widespread issue that affects people from all walks of life. Shockingly, it’s believed that around 80% of adults will experience lower back pain at some point in their lifetime. It can be a severe problem that hinders movement and diminishes one’s quality of life. Additionally, lower back pain is a major cause of disability around the world. The Global Burden of Disease study reports that lower back pain is the leading cause of disability globally.

Back Pain

Low back pain refers usually to pain in the lumbar vertebrae of the lower back. It can be debilitating and is difficult to treat in the long term. A new method based on cognition, emotions, and behavior has shown good results in a clinical trial.

Restore is a Phase 3 clinical trial conducted in 20 clinics in Australia, involving about 500 adults with chronic low back pain, many of whom have had significant disability for more than three months. Low back pain, the leading cause of disability worldwide, is difficult to treat and most interventions have a small to moderate effect and are short-lived.

Cognitive functional therapy, an unconventional approach

The study, published in The Lancet journal, was conducted by an international team of low back pain experts. It uses Cognitive functional therapy (CFT), an individualized approach that targets harmful pain-related cognitions, emotions, and behaviors that contribute to pain and disability. “This method differs from traditional, more passive approaches such as massage, spinal manipulation, medications, and injections, as it empowers the person to take control of their condition and helps them understand the factors that contribute to pain,” explains coauthor and Professor O’Sullivan.

The researchers set out to compare the effectiveness of CFT (delivered with or without feedback from trained physical therapists) with usual care, dividing the participants into three balanced groups. Patients tried the program in seven sessions over a 12-week period, followed by a booster session after six months. Both interventions were more effective than usual care in reducing pain and pain-related disability, even after one year of follow-up. More than 80% of the participants were satisfied with the treatment.