The DOI matches its Crossref record; 152 of the 158 references it cites were found in a registry or an index.
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations
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.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“This trial followed the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, or IMMPACT, recommendations for chronic pain clinical trials [31] and the Consolidated Standards of Reporting Trials, or CONSORT, recommendations for randomised, controlled trials [32].”
From Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: A randomised controlled trial (2011) · cites this paper as [31]
Citations
Cites
Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., & McQuay, H. J. (1996) · Controlled Clinical Trials · doi:10.1016/0197-2456(95)00134-4 · Cited by 17,582
Self-citationCore outcome measures for chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., Kerns, R. D., Stucki, G., Allen, R. R., Bellamy, N., et al. (2005) · Pain · doi:10.1016/j.pain.2004.09.012 · Cited by 3,732
Self-citationCore outcome domains for chronic pain clinical trials: IMMPACT recommendations
Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., Cleeland, C., Dionne, R., Farrar, J. T., Galer, B. S., et al. (2003) · Pain · doi:10.1016/j.pain.2003.08.001 · Cited by 3,510
Self-citationDworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Kerns, R. D., Ader, D. N., et al. (2008) · The Journal of Pain · doi:10.1016/j.jpain.2007.09.005 · Cited by 3,471
Self-citationClassification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms
Merskey, H. (1994) · Medical Entomology and Zoology · Cited by 3,362
Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., Ader, D., Fries, J. F., Bruce, B., & Rose, M. (2007) · Medical Care · doi:10.1097/01.mlr.0000258615.42478.55 · Cited by 3,118
Self-citationTreede (2008) · doi:10.1212/01.wnl.0000282763.29778.59 · Cited by 2,746
Altman, R. D., Alarcón, G. S., Appelrouth, D. J., Bloch, D. A., BORENSTEIN, D. G., Brandt, K. D., Brown, C., Cooke, T. D. V., Daniel, W., Feldman, D. P., et al. (1991) · Arthritis & Rheumatism · doi:10.1002/art.1780340502 · Cited by 2,631
Rolke, R., Baron, R., Maier, C., Tölle, T. R., Treede, R., Beyer, A., Binder, A., Birbaumer, N., Birklein, F., Bötefür, I. C., et al. (2006) · Pain · doi:10.1016/j.pain.2006.01.041 · Cited by 2,606
Self-citationKirsch, I., Deacon, B. J., Huedo-Medina, T. B., Scoboria, A., Moore, T. J., & Johnson, B. T. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050045 · Cited by 2,442
Cited by
Sorted by citations
Hershman, D. L., Lacchetti, C., Dworkin, R. H., Smith, E., Bleeker, J. S., Cavaletti, G., Chauhan, C., Gavin, P., Lavino, A., Lustberg, M. B., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.54.0914 · Cited by 1,210
Self-citationSmith, E., Pang, H., Cirrincione, C., Fleishman, S. B., Paskett, E. D., Ahles, T. A., Bressler, L. R., Fadul, C. E., Knox, C., Le-Lindqwister, N. A., et al. (2013) · JAMA · doi:10.1001/jama.2013.2813 · Cited by 1,016
Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses
Hughes, L. S., Clark, J., Colclough, J. A., Dale, E., & McMillan, D. (2017) · The Clinical Journal of Pain · doi:10.1097/ajp.0000000000000425 · Cited by 611
Non-invasive brain stimulation techniques for chronic pain
O'Connell, N. E., Wand, B. M., Marston, L., Spencer, S., & DeSouza, L. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008208.pub3 · Cited by 488
Mekhail, N., Levy, R. M., Deer, T. R., Kapural, L., Li, S., Amirdelfan, K., Hunter, C. W., Rosen, S. M., Costandi, S. J., Falowski, S. M., et al. (2020) · The Lancet Neurology · doi:10.1016/s1474-4422(19)30414-4 · Cited by 357
Metadata
- Authors
- Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., Chappell, A., Chartier, K., Cleeland, C. S., Costello, A., Cowan, P., Dimitrova, R., Ellenberg, S., Farrar, J. T., French, J. A., Gilron, I., Hertz, S., Jadad, A. R., Jay, G. W., Kalliomäki, J., Katz, N. P., Kerns, R. D., Manning, D. C., McDermott, M. P., McGrath, P. J., Narayana, A., Porter, L., Quessy, S., Rappaport, B. A., Rauschkolb, C., Reeve, B. B., Rhodes, T., Sampaio, C., Simpson, D. M., Stauffer, J. W., Stucki, G., Tobias, J., White, R. E., & Witter, J.
- Affiliations
- Dalhousie University (CA)
- University of Washington (US)
- Christian-Albrechts-Universität zu Kiel (DE)
- The University of Queensland (AU)
- United States Food and Drug Administration (US)
- Eli Lilly (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- American Chronic Pain Association (US)
- New York University (US)
- Queen's University (CA)
- University of Toronto (CA)
- AstraZeneca (Sweden) (SE)
- United States Department of Veterans Affairs (US)
- University of Rochester (US)
- Izaak Walton Killam Health Centre (CA)
- National Institutes of Health (US)
- Janssen Research & Development (United States) (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- University of Lisbon (PT)
- University of Rochester Medicine (US)
- University of Lucerne (CH)
- Corresponding author
- Dworkin, Robert H.
- ORCID
- Dworkin, Robert H.
- Baron, Ralf
- Burke, Laurie B.
- Cleeland, Charles S.
- Ellenberg, Susan
- Farrar, John T.
- French, Jacqueline A.
- Gilron, Ian
- Hertz, Sharon
- Jadad, Alejandro R.
- Katz, Nathaniel P.
- Kerns, Robert D.
- McDermott, Michael P.
- McGrath, Patrick J.
- Reeve, Bryce B.
- Rhodes, Thomas
- Sampaio, Cristina
- Simpson, David M.
- Stucki, Gerold
- Tobias, Jeffrey
- Venue
- Pain
- Published
- 2010-05
- Volume
- 149
- Issue
- 2
- Pages
- 177-193
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W2061974517
- Cited by
- 381
- References
- 158
- Citations by year
- 2026: 6 · 2025: 18 · 2024: 11 · 2023: 21 · 2022: 39 · 2021: 23 · 2020: 27 · 2019: 27 · 2018: 19 · 2017: 20 · 2016: 24 · 2015: 20 · 2014: 27 · 2013: 36 · 2012: 27
- FWCI
- 27.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
- Keywords
- chronic pain, confirmatory trials, research design, IMMPACT, clinical trial design, participant selection, assay sensitivity, analgesic efficacy, placebo response
- MeSH terms
- Analgesics, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Pain Measurement, Pain, Intractable, Intractable Pain, Random Allocation, Research Design, Outcome Assessment, Health Care, Patient Selection
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
