Task Force Recommendations: New Standards for Chronic Low-Back Pain Studies
I’m pleased to let you know that the NIH Pain Consortium’s Task Force on Research Standards for Chronic Low Back Pain has released its report on recommended research standards. A related article is in press in the Journal of Pain, and more articles are slated to be published in other leading pain journals.
By way of quick background: chronic low-back pain (cLBP) is a major societal problem around the world, including in the United States. Over the past couple of decades, despite increased utilization of all forms of treatment, the rates of incidence, prevalence, and functional disability for cLBP have all risen. Unfortunately, regardless of treatment approach, many patients continue to have pain, with major negative impact upon their lives.
In a previous blog post, I outlined the difficulties with comparing cLBP studies and reaching consensus about benefits of various interventions. This situation developed mostly because of use of differing definitions, eligibility criteria, assessments, and outcome measures. In order for the science to move ahead, and for discoveries to eventually impact clinical practice, more consistent standards for clinical studies were needed.
After 2 years of research, meetings, and deliberation, the Task Force has published a report containing six recommendations regarding standards for clinical research on cLBP:
- A definition of cLBP, based on two questions: (1) How long has back pain been a problem? (2) What fraction of days in the past 6 months have involved back pain?
- Classification of cLBP by impact—consisting of the intensity of pain, its interference with normal activities, and the patient’s functional status
- A minimal and uniform set of data to be reported in all studies—on medical history, physical examination, diagnostic tests, and self-report measures (in addition to pain intensity and pain interference)
- Outcome measures, to include a responder analysis
- Areas to research further, to either validate or further develop the research standards
- Dissemination of the recommended standards to the broader research community, including Federal agencies that fund research on cLBP.
The research standards are envisioned as dynamic, and are expected to evolve as new data relevant to cLBP are obtained. For all of us who study back pain, treat it, and/or live with it, I believe that this work represents a major step forward, and I congratulate the Task Force members. NCCAM’s portfolio of low-back pain research will surely benefit from these efforts.