title: Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.
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.
authors.affiliation: Centre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom.
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authors.lastname: Taylor
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Kristine
authors.initials: K
authors.lastname: Phillips
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Kushang V
authors.initials: KV
authors.lastname: Patel
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
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authors.initials: DC
authors.lastname: Turk
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.affiliation: Department of Occupational Science and Occupational Therapy, University of Toronto, ON, Canada.|Institute for Work and Health, University of Toronto, ON, Canada.
authors.forename: Dorcas
authors.initials: D
authors.lastname: Beaton
authors.affiliation: Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Clauw
authors.affiliation: Institute for Work and Health, University of Toronto, ON, Canada.
authors.forename: Monique A M
authors.initials: MAM
authors.lastname: Gignac
authors.affiliation: Department of Neurology, University of Rochester, Rochester, NY, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Markman
authors.affiliation: Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
authors.forename: David A
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authors.affiliation: Depomed, Newark, CA, USA.
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authors.affiliation: LORAGroup LLC, Royal Oak, MD, USA.|Department of Health Services Research University of Maryland, Baltimore, MD, USA.
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authors.initials: LB
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authors.affiliation: Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Carr
authors.affiliation: Division of Infection and Immunity, Cardiff University, Cardiff, Wales, United Kingdom.
authors.forename: Ernest H
authors.initials: EH
authors.lastname: Choy
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.|Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.affiliation: American Chronic Pain Association, Rocklin, CA, USA.
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authors.affiliation: Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
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authors.initials: JT
authors.lastname: Farrar
authors.affiliation: Department of Neurology, Harvard University, Cambridge, MA, USA.
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authors.lastname: Freeman
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Jennifer
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authors.lastname: Gewandter
authors.affiliation: Department of Anesthesiology, Queen's University, Ottawa, ON, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.affiliation: Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.|Pfizer, Inc, Durham, NC, USA.
authors.forename: Veeraindar
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authors.lastname: Goli
authors.affiliation: Clinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command.
authors.forename: Tony D
authors.initials: TD
authors.lastname: Gover
authors.affiliation: Purdue Pharma L.P., Stamford, CT, USA.
authors.forename: J David
authors.initials: JD
authors.lastname: Haddox
authors.affiliation: Department of Veterans Affairs, Veteran Affairs Connecticut Healthcare System, West Haven, CT, USA.|Department of Psychiatry and Psychology, Yale University, New Haven, CT, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.affiliation: Collegium Pharmaceuticals, Inc, Canton, MA, USA.
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authors.affiliation: Chadds Ford, Pennsylvania, PA, USA.
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authors.forename: Richard
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authors.lastname: Malamut
authors.affiliation: Rheumatology Clinic Research Division, Swedish Medical Center, Seattle, WA, USA.|School of Medicine, University of Washington, Seattle, WA, USA.|Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
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authors.lastname: Mease
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authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
authors.affiliation: Medical Service, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.|Department of Orthopedic Surgery, Mayo Clinic, College of Medicine, Rochester, MN, USA.
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.affiliation: Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
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authors.affiliation: Faculty of Medicine, the Centre for Global Health, University of Ottawa, Ottawa, ON, Canada.
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authors.lastname: Veasley
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Walco
authors.affiliation: Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Ajay D
authors.initials: AD
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authors.affiliation: National Institutes of Health, Bethesda, MD, USA.
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mesh_terms: D059350:Chronic Pain / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards*; D059408:Pain Management / Q000379:methods* / Q000592:standards; D010147:Pain Measurement / Q000379:methods; D011788:Quality of Life / Q000523:psychology; D058992:Social Participation / Q000523:psychology; D016896:Treatment Outcome