Journal ArticleDOI
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.
Robert H. Dworkin,Dennis C. Turk,Sarah Peirce-Sandner,Ralf Baron,Nicholas Bellamy,Laurie B. Burke,Amy S. Chappell,Kevin Chartier,Charles S. Cleeland,Ann Costello,Penney Cowan,Rozalina Dimitrova,Susan S. Ellenberg,John T. Farrar,Jacqueline A. French,Ian Gilron,Sharon Hertz,Alejandro R. Jadad,Gary W. Jay,Jarkko Kalliomäki,Nathaniel P. Katz,Robert D. Kerns,Donald C. Manning,Michael P. McDermott,Patrick J. McGrath,Arvind Narayana,Linda Porter,Steve Quessy,Bob A. Rappaport,Christine Rauschkolb,Bryce B. Reeve,Thomas Rhodes,Cristina Sampaio,David M. Simpson,Joseph W. Stauffer,Gerold Stucki,Jeffrey Tobias,Richard E. White,James Witter +38 more
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In this paper, the authors present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials.Abstract:
There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.read more
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Journal ArticleDOI
Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline
Dawn L. Hershman,Christina Lacchetti,Robert H. Dworkin,Ellen M. Lavoie Smith,Jonathan Bleeker,Guido Cavaletti,Cynthia Chauhan,Patrick Gavin,Antoinette Lavino,Maryam B. Lustberg,Judith A. Paice,Bryan P. Schneider,Mary Lou Smith,Thomas J. Smith,Shelby A. Terstriep,Nina D. Wagner-Johnston,Kate Bak,Charles L. Loprinzi +17 more
TL;DR: Although the CIPN trials are inconclusive regarding tricyclic antidepressants (such as nortriptyline), gabapentin, and a compounded topical gel containing baclofen, amitriptylines HCL, and ketamine, these agents may be offered on the basis of data supporting their utility in other neuropathic pain conditions given the limited other CIPn treatment options.
Journal ArticleDOI
Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial
Ellen M. Lavoie Smith,Herbert Pang,Constance Cirrincione,Stewart B. Fleishman,Electra D. Paskett,Tim A. Ahles,Linda R. Bressler,Camilo E. Fadul,Chetaye Knox,Nguyet Le-Lindqwister,Paul Gilman,Charles L. Shapiro,Charles L. Shapiro +12 more
TL;DR: Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain, and the primary hypothesis was that dulOxetine would be more effective than placebo in decreasing chemotherapy- induced peripheral neuropathic pain.
Journal ArticleDOI
Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses.
TL;DR: The evidence is promising for ACT in the treatment of chronic pain and further methodologically robust trials are required, although it is possible that methodological limitations may have led to overestimated effects.
Journal ArticleDOI
Non-invasive brain stimulation techniques for chronic pain.
TL;DR: A short-term effect on pain is found of active high-frequency stimulation of the motor cortex in single-dose studies of repetitive transcranial magnetic stimulation and this equates to a 12% reduction in pain, which does not exceed the pre-established criteria for a minimal clinically important difference.
Journal ArticleDOI
Combination pharmacotherapy for the treatment of neuropathic pain in adults
TL;DR: A meta-analysis involving 386 participants from two studies demonstrated modest, yet statistically significant, superiority of a gabapentin + opioid combination over gababentin alone, however, this combination also produced significantly more frequent side effect-related trial dropouts compared to gabAPentin alone.
References
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Journal ArticleDOI
Assessing the quality of reports of randomized clinical trials : is blinding necessary?
Alejandro R. Jadad,R. A. Moore,Dawn Carroll,C. Jenkinson,David Reynolds,David J. Gavaghan,Henry J McQuay +6 more
TL;DR: An instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research is described and its use to determine the effect of rater blinding on the assessments of quality is described.
Book
Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms
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
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