Cited by 208Musculoskeletal pain and rehabilitationPain Management and Opioid UsePain Mechanisms and Treatments

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Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations

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Taylor, Ann M., Phillips, Kristine, Patel, Kushang V., Turk, Dennis C., Dworkin, Robert H., Beaton, Dorcas, Clauw, Daniel J., Gignac, Monique A.M., Markman, John D., Williams, David A., Bujanover, Shay, Burke, Laurie B., Carr, Daniel B., Choy, Ernest H., Conaghan, Philip G., Cowan, Penney, Farrar, John T., Freeman, Roy, Gewandter, Jennifer, Gilron, Ian, Goli, Veeraindar, Gover, Tony D., Haddox, J. David, Kerns, Robert D., Kopecky, Ernest A., Lee, David A., Malamut, Richard, Mease, Philip, Rappaport, Bob A., Simon, Lee S., Singh, Jasvinder A., Smith, Shannon M., Strand, Vibeke, Tugwell, Peter, Vanhove, Gertrude F., Veasley, Christin, Walco, Gary A., Wasan, Ajay D., Witter, James·2016·Pain

DOI 10.1097/j.pain.0000000000000577PMC PMC7453823

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Abstract

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

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Authors: Taylor, A. M., Phillips, K., Patel, K. V., Turk, D. C., Dworkin, R. H., Beaton, D., Clauw, D. J., Gignac, M. A. M., Markman, J. D., Williams, D. A., Bujanover, S., Burke, L. B., Carr, D. B., Choy, E. H., Conaghan, P. G., Cowan, P., Farrar, J. T., Freeman, R., Gewandter, J., Gilron, I., Goli, V., Gover, T. D., Haddox, J. D., Kerns, R. D., Kopecky, E. A., Lee, D. A., Malamut, R., Mease, P., Rappaport, B. A., Simon, L. S., Singh, J. A., Smith, S. M., Strand, V., Tugwell, P., Vanhove, G. F., Veasley, C., Walco, G. A., Wasan, A. D., & Witter, J.
Affiliations: Cardiff University (GB)
University of Michigan (US)
University of Washington (US)
University of Rochester Medicine (US)
University of Toronto (CA)
Depomed (United States) (US)
University of Maryland, Baltimore (US)
Tufts University (US)
University of Leeds (GB)
American Chronic Pain Association (US)
University of Pennsylvania (US)
Harvard University (US)
Queen's University (CA)
Pfizer (United States) (US)
United States Army Medical Research and Development Command (US)
Purdue Pharma (United States) (US)
Yale University (US)
Collegium Pharmaceutical (United States) (US)
Ford Motor Company (United States) (US)
Mayo Clinic (US)
Stanford Medicine (US)
University of Ottawa (CA)
Jazz Pharmaceuticals, Palo Alto, CA, USA
National Institutes of Health (US)
ORCID: Taylor, Ann M.
Patel, Kushang V.
Dworkin, Robert H.
Beaton, Dorcas
Clauw, Daniel J.
Gignac, Monique A.M.
Markman, John D.
Williams, David A.
Burke, Laurie B.
Choy, Ernest H.
Conaghan, Philip G.
Farrar, John T.
Freeman, Roy
Gewandter, Jennifer
Gilron, Ian
Haddox, J. David
Kerns, Robert D.
Kopecky, Ernest A.
Mease, Philip
Simon, Lee S.
Singh, Jasvinder A.
Smith, Shannon M.
Strand, Vibeke
Tugwell, Peter
Veasley, Christin
Walco, Gary A.
Wasan, Ajay D.
Venue: Pain
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2016-04-07
Volume: 157
Issue: 9
Pages: 1836-1850
ISSN: 0304-3959 (ISSN-L)
1872-6623
DOI: 10.1097/j.pain.0000000000000577
PMC: PMC7453823
OpenAlex: W2338379519
Cited by: 208
References: 205
Citations by year: 2026: 14 · 2025: 28 · 2024: 19 · 2023: 23 · 2022: 17 · 2021: 28 · 2020: 17 · 2019: 22 · 2018: 23 · 2017: 14 · 2016: 3
FWCI: 2.36
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Pain (publishedVersion)
PubMed (publishedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
PubMed Central (acceptedVersion)
ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
Funders: U.S. Food and Drug Administration (U01-FD005936)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (K23AR060241, L30 AR065256, R01AR059102)
Topics: Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Keywords: chronic pain, physical function, participation, patient-reported outcomes, performance-based measures, work participation, social participation (health and rehabilitation), caregiver burden, outcome measurement, clinical trial design, IMMPACT, OMERACT, standardization of outcome measures
MeSH terms: Clinical Trials as Topic, Humans, Pain Measurement, Quality of Life, Treatment Outcome, Outcome Assessment, Health Care, Social Participation, Chronic Pain, Pain Management

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Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations

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