Standardized research methods that promote consistency are needed to make greater progress toward reducing the high burden and costs of chronic low back pain, according to a National Institutes of Health Task Force report.
The article, which was published in the June 15 issue of the journal Spine, introduces a set of proposed research standards to help in comparing the results of chronic low back pain studies. The recommendations were developed by a Research Task Force convened by the NIH Pain Consortium. The co-chairs were Richard A. Deyo, MD, MPH, of Oregon Health and Science University in Portland and Samuel F. Dworkin, DDS, PhD, of University of Washington in Seattle. The task force included Anthony Delitto, PT, PhD, FAPTA, of the University of Pittsburgh.
Chronic low back pain is a major cause of pain and disability in the U.S., with high costs for healthcare and the economy. Many different treatments have been developed and tested, but few have consistently shown substantial, long-term reduction in pain with improvement in functioning.
Researchers use varied inclusion criteria, definitions, baseline assessments and outcome measures, which impede comparisons and consensus, the task force members wrote.
Members of the task force used a structured approach to develop a set of standards for chronic low back pain research. Key issues included defining the problem, assessing its impact on patients lives, identifying the minimum dataset that should be collected in chronic low back pain research, and defining the best outcomes to evaluate treatment effectiveness.
Definition: Research consistency begins with a standard definition of the problem. The task force recommended chronic low back pain be defined as back pain lasting at least three months and causing pain on at least half of days during the past six months. The definition does not include ratings of pain severity.
Impact: The group recommends focusing on how back pain is affecting patients lives. The recommendations suggest a nine-item Impact Score, which incorporates ratings of pain intensity, interference with normal activities and functional ability.
Minimum dataset: For any study of chronic low back pain, the task force recommends the minimum dataset include legal or workers compensation issues, previous treatments and important contributing factors especially smoking, obesity, substance abuse and widespread pain. The recommendations emphasize the importance of assessing the patients medical history even more so than the physical examination. The task force specified no standard laboratory or imaging tests, based on a lack of association with patient symptoms or functioning. Assessments of physical functioning, depression, sleep disturbance and catastrophic thinking were rated important.
Outcomes: The task force attempted to define the most important outcomes to be evaluated in chronic low back pain studies. However, they concluded there was no agreed-on definition of what degree of improvement should be considered clinically important. They also did not reach a consensus on the use of combined outcome measures, time frames for improvement or adverse effects.
Future research: Developing and testing new combined outcome measures was identified as an important area for future research. Other areas included approaches to predicting treatment results and studies to evaluate and improve the minimum dataset.
The task force aimed to have the recommended standards reflect the complex, intertwined factors affecting the development and clinical course of chronic low back pain.
As adopted by NIH, these recommendations have the potential to standardize methods for identifying [chronic low back pain]research cases, describing research subjects and comparing published reports, the task force members wrote.
The authors wrote the recommendations should be regarded as a dynamic document that will need further validation and refinement in the years ahead.
Abstract and link to PDF: http://1.usa.gov/1l1TKEH
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