An NIH Task Force report indicates that standardized research methods are required in order to advance progress toward reducing the elevated burden and costs of chronic low back pain (cLBP). A news release from Wolters Kluwer Health notes that a Research Task Force convened by the NIH Pain Consortium developed the recommendations.
The report, which appears in the June 15 issue of Spine, provides a set of proposed research standards intended to assist in comparing the results of cLBP studies. The release states that while many different treatments for cLBP have been developed and tested, few have consistently shown substantial, long-term reduction in pain with improvement in functioning.
In an effort to combat this issue, the Task Force implemented a structured approach to developing a set of standards for cLBP research. Key issues reportedly included defining the problem of cLBP, assessing its impact on patients’ lives, pinpointing the minimum database that should be collected in cLBP research, and defining the best outcomes to evaluate treatment effectiveness.
The recommended definition of the problem of cLBP by the Task Force, the release says, was back pain lasting at least 3 months, and causing pain on at least half of days during the past 6 months. The definition does not include ratings of pain severity, the release states.
To address the impact of cLBP on patients’ lives, the Task Force recommends focusing on how it is affecting their lives. The recommendations suggest that a nine-item cLBP “Impact Score,” be used, incorporating ratings of pain intensity, interference with normal activities, and functional ability.
Another key task set forth in the article was defining a minimum set of data to be gathered in any study of cLBP. The recommended dataset included legal or workers compensation issues, previous treatments, and key contributing factors, particularly smoking, obesity, substance abuse, and widespread pain.
As stated in the release, the recommendations also center on the importance of investigating a patient’s medical history. The Task Force did not specify laboratory or imaging tests, citing the lack of association with patient symptoms or functioning. Assessments of physical functioning, depression, sleep disturbance, and catastrophic thinking were rated as important for all groups of patients with cLBP.
Additionally, the Task Force also worked to define the most important outcomes to be evaluated in cLBP studies. Yet, they ultimately concluded that there was no agreed-on definition of what degree of improvement should be considered “clinically important.” The release reports that there was also no consensus regarding the use of blended outcome measures, time frames for improvement, or adverse effects.
An important area for future research that was identified included developing and testing new blended outcome measures. Others encompassed strategies to predict treatment results and studies to evaluate and improve the minimum dataset.
The Task Force states in the article, “As adopted by NIH, these recommendations have the potential to standardize methods for identifying cLBP research cases, describing research subjects, and comparing published reports.”
The Task Force adds the recommendations are a “dynamic document” requiring further validation and refinement in the coming years.
Task Force co-chairs were Richard A. Deyo, MD, MPH, of Oregon Health and Science University, Portland; and Samuel F. Dworkin, DDS, PhD, of University of Washington, Seattle.
Source(s): Wolters Kluwer Health, EurekAlert