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

Ann M Taylor¹, Kristine Phillips², Kushang V Patel³, Dennis C Turk³, Robert H Dworkin⁴, Dorcas Beaton^{5

6}, Daniel J Clauw⁷, Monique A M Gignac⁶, John D Markman⁸, David A Williams⁷, Shay Bujanover⁹, Laurie B Burke^{10

11}, Daniel B Carr¹², Ernest H Choy¹³, Philip G Conaghan^{14

15}, Penney Cowan¹⁶, John T Farrar¹⁷, Roy Freeman¹⁸, Jennifer Gewandter⁴, Ian Gilron¹⁹, Veeraindar Goli^{20

21}, Tony D Gover²², J David Haddox²³, Robert D Kerns^{24

25}, Ernest A Kopecky²⁶, David A Lee²⁷, Richard Malamut²⁸, Philip Mease^{29

30

31}, Bob A Rappaport³², Lee S Simon³³, Jasvinder A Singh^{34

35}, Shannon M Smith⁴, Vibeke Strand³⁶, Peter Tugwell³⁷, Gertrude F Vanhove³⁸, Christin Veasley³⁹, Gary A Walco³, Ajay D Wasan⁴⁰, James Witter⁴¹

Affiliations

¹ Centre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom.
² Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
³ Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
⁴ Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
⁵ Department of Occupational Science and Occupational Therapy, University of Toronto, ON, Canada.
⁶ Institute for Work and Health, University of Toronto, ON, Canada.
⁷ Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
⁸ Department of Neurology, University of Rochester, Rochester, NY, USA.
⁹ Depomed, Newark, CA, USA.
¹⁰ LORAGroup LLC, Royal Oak, MD, USA.
¹¹ Department of Health Services Research University of Maryland, Baltimore, MD, USA.
¹² Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
¹³ Division of Infection and Immunity, Cardiff University, Cardiff, Wales, United Kingdom.
¹⁴ NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.
¹⁵ Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom.
¹⁶ American Chronic Pain Association, Rocklin, CA, USA.
¹⁷ Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
¹⁸ Department of Neurology, Harvard University, Cambridge, MA, USA.
¹⁹ Department of Anesthesiology, Queen's University, Ottawa, ON, Canada.
²⁰ Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.
²¹ Pfizer, Inc, Durham, NC, USA.
²² Clinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command.
²³ Purdue Pharma L.P., Stamford, CT, USA.
²⁴ Department of Veterans Affairs, Veteran Affairs Connecticut Healthcare System, West Haven, CT, USA.
²⁵ Department of Psychiatry and Psychology, Yale University, New Haven, CT, USA.
²⁶ Collegium Pharmaceuticals, Inc, Canton, MA, USA.
²⁷ Chadds Ford, Pennsylvania, PA, USA.
²⁸ Teva Pharmaceuticals, North Wales, PA, USA.
²⁹ Rheumatology Clinic Research Division, Swedish Medical Center, Seattle, WA, USA.
³⁰ School of Medicine, University of Washington, Seattle, WA, USA.
³¹ Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
³² Analgesic Concepts LLC, Arlington, VA, USA.
³³ SDG Consulting LLC, Cambridge, MA, USA.
³⁴ Medical Service, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
³⁵ Department of Orthopedic Surgery, Mayo Clinic, College of Medicine, Rochester, MN, USA.
³⁶ Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
³⁷ Faculty of Medicine, the Centre for Global Health, University of Ottawa, Ottawa, ON, Canada.
³⁸ Jazz Pharmaceuticals, Palo Alto, CA, USA.
³⁹ Chronic Pain Research Alliance.
⁴⁰ Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁴¹ National Institutes of Health, Bethesda, MD, USA.

PMID: 27058676
PMCID: PMC7453823
DOI: 10.1097/j.pain.0000000000000577

Review

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

Ann M Taylor et al. Pain. 2016 Sep.

. 2016 Sep;157(9):1836-1850.

doi: 10.1097/j.pain.0000000000000577.

Authors

Affiliations

¹ Centre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom.
² Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
³ Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
⁴ Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
⁵ Department of Occupational Science and Occupational Therapy, University of Toronto, ON, Canada.
⁶ Institute for Work and Health, University of Toronto, ON, Canada.
⁷ Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
⁸ Department of Neurology, University of Rochester, Rochester, NY, USA.
⁹ Depomed, Newark, CA, USA.
¹⁰ LORAGroup LLC, Royal Oak, MD, USA.
¹¹ Department of Health Services Research University of Maryland, Baltimore, MD, USA.
¹² Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
¹³ Division of Infection and Immunity, Cardiff University, Cardiff, Wales, United Kingdom.
¹⁴ NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.
¹⁵ Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom.
¹⁶ American Chronic Pain Association, Rocklin, CA, USA.
¹⁷ Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
¹⁸ Department of Neurology, Harvard University, Cambridge, MA, USA.
¹⁹ Department of Anesthesiology, Queen's University, Ottawa, ON, Canada.
²⁰ Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.
²¹ Pfizer, Inc, Durham, NC, USA.
²² Clinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command.
²³ Purdue Pharma L.P., Stamford, CT, USA.
²⁴ Department of Veterans Affairs, Veteran Affairs Connecticut Healthcare System, West Haven, CT, USA.
²⁵ Department of Psychiatry and Psychology, Yale University, New Haven, CT, USA.
²⁶ Collegium Pharmaceuticals, Inc, Canton, MA, USA.
²⁷ Chadds Ford, Pennsylvania, PA, USA.
²⁸ Teva Pharmaceuticals, North Wales, PA, USA.
²⁹ Rheumatology Clinic Research Division, Swedish Medical Center, Seattle, WA, USA.
³⁰ School of Medicine, University of Washington, Seattle, WA, USA.
³¹ Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
³² Analgesic Concepts LLC, Arlington, VA, USA.
³³ SDG Consulting LLC, Cambridge, MA, USA.
³⁴ Medical Service, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
³⁵ Department of Orthopedic Surgery, Mayo Clinic, College of Medicine, Rochester, MN, USA.
³⁶ Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
³⁷ Faculty of Medicine, the Centre for Global Health, University of Ottawa, Ottawa, ON, Canada.
³⁸ Jazz Pharmaceuticals, Palo Alto, CA, USA.
³⁹ Chronic Pain Research Alliance.
⁴⁰ Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁴¹ National Institutes of Health, Bethesda, MD, USA.

PMID: 27058676
PMCID: PMC7453823
DOI: 10.1097/j.pain.0000000000000577

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.

PubMed Disclaimer

Conflict of interest statement

The views expressed in this article are those of the authors, none of whom have financial conflicts of interest relevant to the issues discussed in this manuscript.

Figures

**Figure 1.**
A model of disability that is the basis of ICF. ICF = International Classification of Functioning, Disability, and Health

**Figure 2.**
Treatment benefit: what to measure? Schematic diagram depicting the impact of inter-related domains and sub-domains of assessment for chronic diseases. S/Ss = signs and symptoms

See this image and copyright information in PMC

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous