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

Published

Journal Article (Review)

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.

Full Text

Cited Authors

  • Taylor, AM; Phillips, K; Patel, KV; Turk, DC; Dworkin, RH; Beaton, D; Clauw, DJ; Gignac, MAM; Markman, JD; Williams, DA; Bujanover, S; Burke, LB; Carr, DB; Choy, EH; Conaghan, PG; Cowan, P; Farrar, JT; Freeman, R; Gewandter, J; Gilron, I; Goli, V; Gover, TD; Haddox, JD; Kerns, RD; Kopecky, EA; Lee, DA; Malamut, R; Mease, P; Rappaport, BA; Simon, LS; Singh, JA; Smith, SM; Strand, V; Tugwell, P; Vanhove, GF; Veasley, C; Walco, GA; Wasan, AD; Witter, J

Published Date

  • September 2016

Published In

Volume / Issue

  • 157 / 9

Start / End Page

  • 1836 - 1850

PubMed ID

  • 27058676

Pubmed Central ID

  • 27058676

Electronic International Standard Serial Number (EISSN)

  • 1872-6623

International Standard Serial Number (ISSN)

  • 0304-3959

Digital Object Identifier (DOI)

  • 10.1097/j.pain.0000000000000577

Language

  • eng