Journal ArticleDOI
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale
TLDR
Using a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies, and the application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies.Abstract:
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.read more
Citations
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Journal ArticleDOI
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.
Dennis C. Turk,Robert H. Dworkin,Robert R. Allen,Nicholas Bellamy,Nancy A. Brandenburg,Daniel B. Carr,Charles S. Cleeland,Raymond A. Dionne,John T. Farrar,Bradley S. Galer,David J. Hewitt,Alejandro R. Jadad,Nathaniel P. Katz,Lynn D. Kramer,Donald C. Manning,Cynthia McCormick,Michael P. McDermott,Patrick J. McGrath,Steve Quessy,Bob A. Rappaport,James P. Robinson,Mike A. Royal,Lee S. Simon,Joseph W. Stauffer,Wendy M. Stein,Jane Tollett,James Witter +26 more
TL;DR: In this article, the authors provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain, and develop a core set of outcome domains would facilitate comparison and pooling of d
Journal ArticleDOI
Measures of Adult Pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Journal ArticleDOI
Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations
Robert H. Dworkin,Dennis C. Turk,Kathleen W. Wyrwich,Dorcas E. Beaton,Charles S. Cleeland,John T. Farrar,Jennifer A. Haythornthwaite,Mark P. Jensen,Robert D. Kerns,Deborah N. Ader,Nancy A. Brandenburg,Laurie B. Burke,David Cella,Julie Chandler,Penny Cowan,Rozalina Dimitrova,Raymond A. Dionne,Sharon Hertz,Alejandro R. Jadad,Nathaniel P. Katz,Henrik Kehlet,Lynn D. Kramer,Donald C. Manning,Cynthia McCormick,Michael P. McDermott,Henry J McQuay,Sanjay Patel,Linda Porter,Steve Quessy,Bob A. Rappaport,Christine Rauschkolb,Dennis A. Revicki,Margaret Rothman,Kenneth E. Schmader,Brett R. Stacey,Joseph W. Stauffer,Thorsten von Stein,Richard E. White,James Witter,Stojan Zavisic +39 more
TL;DR: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments as discussed by the authors.
Journal ArticleDOI
Topical Review and RecommendationsCore outcome measures for chronic pain clinical trials: IMMPACT recommendations
Robert H. Dworkin,Dennis C. Turk,John T. Farrar,Jennifer A. Haythornthwaite,Mark P. Jensen,Nathaniel P. Katz,Robert D. Kerns,Gerold Stucki,Robert R. Allen,Nicholas Bellamy,Daniel B. Carr,Julie Chandler,Penney Cowan,Raymond A. Dionne,Bradley S. Galer,Sharon Hertz,Alejandro R. Jadad,Lynn D. Kramer,James Witter +18 more
Journal ArticleDOI
Pain: a review of three commonly used pain rating scales.
TL;DR: All three pain-rating scales are valid, reliable and appropriate for use in clinical practice, although the Visual Analogue Scale has more practical difficulties than the Verbal Rating Scale or the Numerical Rating Scale.
References
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Journal ArticleDOI
Clinical Significance of Reported Changes in Pain Severity
TL;DR: The minimum clinically significant change in patient pain severity measured with a 100-mm visual analog scale was 13 mm, and studies of pain experience that report less than a 13-mm change in pain severity, although statistically significant, may have no clinical importance.
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