Comparison of sinew-strengthening exercise with cognitive-behavioral therapy for chronic nonspecific low back pain: protocol for a randomized controlled clinical trial

Background Chronic low back pain is a common disease in clinic. The prevention and treatment of this disease requires a great deal of medical care resources, which is now the third medical economic burden in China. Although non-steroidal analgesics have been shown to be effective for chronic low back pain, considering the obvious side effects of these drugs, more and more patients are inclined to employ non-drug therapies. Typical examples are exercise therapy and cognitive-behavioral therapy (CBT). Exercise therapy of traditional Chinese medicine is an important part of non-drug therapy in China, such as sinew-strengthening exercise (SSE). Originating from traditional Chinese medicine exercise therapy, it has long been used for the prevention and treatment of chronic low back pain in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (SGH), but it has not been validated by clinical trials. In this trial, we will seek to determine whether SSE is an effective and safe treatment option for persons with chronic nonspecific low back pain (CNLBP) by comparing it with CBT and explore a new method to CNLBP.Methods/Design In this trial, we will randomize 480 adults with nonspecific chronic back pain to CBT and SSE arms (240 per group). Participants in both groups will be followed for 52 weeks after randomization with home practice. Interviewers will assess outcomes 4, 8, 26 and 52 weeks postrandomization. The primary outcome will be Roland-Morris Disability Questionnaire (RMDQ) with 26-week follow-up being the primary endpoint.Discussion If SSE is found to be an effective treatment option for patients with chronic back pain, it will become a meritorious addition to the current limited treatment approaches available to patients with significant psychosocial contributors to their pain.