New Standards Being Developed for Studying Low-back Pain
As we know, chronic low back pain (cLBP) is an enormous public-health problem—and a frustrating one to patients, health-care providers, and researchers. Up to one-quarter of Americans experience LBP per year, and for some, that pain becomes chronic—a condition that costs the United States an estimated $100 billion per year. Current best practices for its diagnosis and treatment are only partially successful.
In March 2013, the Annals of Family Medicine published findings from an NCCAM-supported study on osteopathic manual treatment (OMT), compared with ultrasound, as a short term complementary treatment for cLBP. This study found that there was a modest but statistically significant improvement in reported pain, though not in function, among study participants receiving OMT. The good news is that this study adds to the growing body of evidence suggesting that spinal manipulation and other non-pharmacological interventions can be at least somewhat helpful for some patients with cLBP.
The bad news is that it is difficult to put this and many other studies on cLBP into a larger perspective because researchers often use inconsistent terminology, case definitions, baseline assessments and outcome measures. As a result, it can be challenging to compare studies of various interventions, replicate findings, pool data from multiple studies, resolve conflicting conclusions, and/or develop consensus regarding interpretation of findings.
Addressing the challenge of comparing data across different studies is the charge of the Task Force on Research Standards for Chronic Low Back Pain. The Task Force, which is a working group of the NIH Pain Consortium, was formed following two NIH workshops in 2009 and 2010 on research challenges and needs related to back pain. A key outcome of these workshops has been the call for common standards, measures, and other tools to be used in future clinical research on cLBP. Examples of needed standardized data include a common definition of cLBP, study-eligibility criteria, minimal dataset of assessments, and measures of cLBP outcomes.
So far, the Task Force has held three meetings since 2012. Members have been reviewing existing evidence, discussing those findings and proposed concepts, and drafting elements and language. Helpful pre-existing examples and processes have been the NINDS Common Data Elements project and the Research Diagnostic Criteria process. The next steps will be to create a formal written draft of the standards, obtain feedback from key stakeholders, and publish/disseminate the standards.
I am very enthusiastic about this endeavor and thank the impressive cadre of experts serving on the task force. I believe that we can all look forward to the “boost” these new standards will give research on cLBP and the eventual impact on clinical practice.