Medical Research: What are the main findings of the study?
Were any of the findings unexpected?
Dr. Bronfort: Our study found that spinal manipulative therapy SMT coupled with home exercise and advice (HEA) appears to be helpful compared to home exercise and advice alone (especially in the short term) for patients with sub-acute and chronic back-related leg pain (BRLP). BRLP was defined as radiating pain originating from the lumbar spine, which travels into the proximal or distal lower extremity, with or without neurological signs. Patients with progressive neurological deficits, cauda equina syndrome, spinal fracture, and other potentially serious causes of BRLP (and often candidates for surgery) were EXCLUDED.
There were a few things we did find to be quite interesting. First, it is notable that the spinal manipulative therapy & home exercise and advice group experienced less self-reported medication use after one year than the home exercise and advice alone group (SMT&HEA was 2.6 times more likely to experience fewer medication days than HEA alone at 1 year). Given the growing concerns of overuse of pain medications (and the potential for adverse events and addiction), this is a finding that has important public health consequence.
Another interesting and important finding is that the adverse events observed in this study were only mild to moderate and self-limiting. No serious adverse events occurred that were related to the study interventions. Mild to moderate adverse events (e.g. temporary aggravation of pain, muscle soreness, etc.) were reported by 30% of the patients in the SMT&HEA group, and 42% in the HEA group. This is important as few studies have systematically recorded the side effects and adverse events related to SMT&HEA and HEA alone; this is one of the first, larger clinical trials to do so. These findings are especially notable because SMT is often not recommended for patients with leg symptoms because of safety concerns (which might be related to the previous absence of robust scientific data to support its use).
Finally, while an advantage of SMT& HEA versus HEA was found (especially in the short term), we do find the findings of the HEA alone group to also be of interest. Almost half of the HEA patients experienced a 50% reduction in leg pain symptoms in both the short (at 12 weeks) and long term (at 52 weeks). That’s an important improvement and warrants future investigation. Self-management strategies (like home exercise) that emphasize the importance of movement and fitness, restoration of normal activities, and allow patients to care for themselves embrace important principles for promoting overall health and wellbeing that could have a big impact if routinely put into practice.
Medical Research: What should clinicians and patients take away from your report?
Dr. Bronfort: Consider trying conservative and simple strategies first before medications, injections and surgery for patients with radiating leg pain.
This is one of the first sufficiently powered studies to investigate spinal manipulative therapy for BRLP. We hope this new knowledge will inspire clinicians to think differently about how they treat patients with sub-acute and chronic BRLP. Prior to this study, SMT was considered a viable treatment option for what is known as ‘uncomplicated low back pain’, that is low back pain without radiating pain to the leg. This study shows that for patients WITH radiating leg pain, but without progressive neurological deficits and serious identifiable causes (e.g. spinal fracture, etc.) spinal manipulative therapy, coupled with home exercise and advice, may be helpful for these types of patients as well. This has potentially substantial implications for improving the overall quality of life and wellbeing of BRLP patients, and also for decreasing the overall socio-economic burden of BRLP as a condition.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Bronfort: Future studies should examine patients’ preferences regarding these treatments (especially what motivates them to be engaged in their own self-care, and how SMT might add to the SMT&HEA treatment experience from the patients’ vantage point). The cost-effectiveness of SMT and HEA also needs to be rigorously investigated. We conducted qualitative interviews with all patients in the study, and also collected cost-effectiveness and utility data; these data are currently being analyzed and will be published at a later date.
Also, there is interest in looking more closely at the HEA group used in this study, and how it could be further optimized to meet patients’ preferences and increase the use of self-management. As noted above there is great interest in empowering patients to embrace simple tips and techniques.
Finally, this study did not address the effectiveness of home exercise versus usual medical treatment and/or no treatment at all; future large studies are required to answer these questions.
Gert Bronfort, DC, PhD; Maria A. Hondras, DC, MPH; Craig A. Schulz, DC, MS; Roni L. Evans, DC, PhD; Cynthia R. Long, PhD; and Richard Grimm, MD, PhD
Ann Intern Med. 2014;161(6):381-391. doi:10.7326/M14-0006