Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Scandinavian Journal of Pain

Official Journal of the Scandinavian Association for the Study of Pain

Editor-in-Chief: Breivik, Harald


CiteScore 2017: 0.84

SCImago Journal Rank (SJR) 2017: 0.401
Source Normalized Impact per Paper (SNIP) 2017: 0.452

Online
ISSN
1877-8879
See all formats and pricing
More options …
Volume 13, Issue 1

Issues

Osteoarthritis patients with pain improvement are highly likely to also have improved quality of life and functioning. A post hoc analysis of a clinical trial

Paul M. Peloso / R. Andrew Moore
  • University of Oxford, Pain Research, Nuffield Division of Anaesthetics, The Churchill, Oxford, UK
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Wen-Jer Chen / Hsiao-Yi Lin / Davis F. Gates / Walter L. Straus / Zoran Popmihajlov
Published Online: 2016-10-01 | DOI: https://doi.org/10.1016/j.sjpain.2016.07.002

Abstract

Background

This analysis evaluated whether osteoarthritis patients achieving the greatest pain control and lowest pain states also have the greatest improvement in functioning and quality of life.

Methods

Patients (n = 419) who failed prior therapies and who were switched to etoricoxib 60 mg were categorized as pain responders or non-responders at 4 weeks based on responder definitions established by the Initiative on Methods, Measurement, and Pain (IMMPACT) criteria, including changes from baseline of ≥15%, ≥30%, ≥50%, ≥70% and a final pain status of ≤3/10 (no worse than mild pain). Pain was assessed at baseline and 4 weeks using 4 questions from the Brief Pain Inventory (BPI) (worst pain, least pain, average pain, and pain right now), and also using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale. We examined the relationship between pain responses with changes from baseline in two functional measures (the BPI Pain Interference questions and the WOMAC Function Subscale) as well as changes from baseline in quality of life (assessed on the SF-36 Physical and Mental Component Summaries). We also sought to understand whether these relationships were influenced by the choice of the pain instrument used to assess response. We contrast the mean difference in improvements in the functional and quality of life instruments based on pain responder status (responder versus non-responder) and the associated 95% confidence limits around this difference.

Results

Patients with better pain responses were much more likely to have improved functional responses and improved quality of life, with higher mean changes in these outcomes versus pain nonresponders, regardless of the choice of IMMPACT pain response definition (e.g., using any of 15%, 30%, 50%, 70% change from baseline) or the final pain state of ≤3/10. There was an evident gradient, where higher levels of pain response were associated with greater mean improvements in function and quality of life. The finding that greater pain responses led to greater functional improvements and quality of life gains was not dependent on the manner in which pain was evaluated. Five different pain instruments (e.g., the 4 questions on pain from the BPI pain questionnaire and the WOMAC pain subscale) consistently demonstrated that pain responders had statistically significantly greater improvements in function and quality of life compared to pain non-responders. This suggests these results are likely to be generalizable to any validated pain measure for osteoarthritis.

Conclusions

Pain is an efficient outcome measure for predicting broader patient response in osteoarthritis. Patients who do not achieve timely, acceptable pain states over 4 weeks were less likely to experience functional or quality of life improvements.

Implications

Good pain improvements in osteoarthritis with a valid pain instrument are a proxy for good improvements in both function and quality of life. Therefore proper osteoarthritis pain assessment can lead to efficient evaluations in the clinic.

Keywords: Osteoarthritis; Pain; Patient-reported outcome; Function; Quality of life

References

  • [1]

    Bijlsma JW, Berenbaum F, Lafeber FP, Floris PJ. Osteoarthritis: an update with relevance for clinical practice. Lancet 2011;377:2115–26.CrossrefWeb of SciencePubMedGoogle Scholar

  • [2]

    Moore RA, Straube S, Paine J, Phillips CJ, Derry S, McQuay HJ. Fibromyalgia: moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain. Pain 2010;149:360–4.Web of SciencePubMedCrossrefGoogle Scholar

  • [3]

    Moore RA, Straube S, Eccleston C, Derry S, Aldington D, Wiffen P, Bell RF, Hamunen K, Phillips C, McQuay H. Estimate at your peril: imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses. Pain 2012;153:265–8.CrossrefPubMedGoogle Scholar

  • [4]

    Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr Cartil 2004;12:389–99.PubMedCrossrefGoogle Scholar

  • [5]

    Kapstad H, Hanestad BR, Langeland N, Rustøen T, Stavem K. Cutpoints for mild, moderate and severe pain in patients with osteoarthritis of the hip or knee ready for joint replacement surgery. BMC Musculoskelet Disord 2008:9.PubMedWeb of ScienceGoogle Scholar

  • [6]

    Moore RA, Moore OA, Derry S, Peloso PM, Gammaitoni AR, Wang H. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis 2010;69:374–9.Web of ScienceCrossrefGoogle Scholar

  • [7]

    Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochbert M, van der heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis 2005;64:34–7.CrossrefPubMedGoogle Scholar

  • [8]

    Jensen MP, Hu X, Potts SL, Gould EM. Single vs composite measures of pain intensity: relative sensitivity for detecting treatment effects. Pain 2013;154:534–8.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [9]

    Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105–21.Web of ScienceCrossrefPubMedGoogle Scholar

  • [10]

    Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 2005;64:29–33.CrossrefPubMedGoogle Scholar

  • [11]

    Moore RA, Straube S, Aldington D. Pain measures and cut-offs – ‘no worse than mild pain’ as a simple, universal outcome. Anaesthesia 2013;68:400–12.CrossrefWeb of SciencePubMedGoogle Scholar

  • [12]

    Sator-Katzenschlager SM, Schiesser AW, Kozek-Langenecker SA, Benetka G, Langer G, Kress HG. Does pain relief improve pain behavior and mood in chronic pain patients? Anesth Analg 2003;97:791–7.PubMedGoogle Scholar

  • [13]

    Deshpande MA, Holden RR, Gilron I. The impact of therapy on quality of life and mood in neuropathic pain: what is the effect of pain reduction? Anesth Analg 2006;102:1473–9.PubMedCrossrefGoogle Scholar

  • [14]

    Hoffman DL, Sadosky A, Dukes EM, Alvir J. How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy? Pain 2010;149:194–201.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [15]

    Wise BL, Felson DT, Clancy M, Niu J, Neogi T, Lane NE, Hietpas J, Curtis JR, Bradley LA, Torner JC, Zhang Y. Consistency of knee pain and risk of knee replacement: The Multicenter Osteoarthritis Study. J Rheumatol 2011;38:1390–5.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [16]

    Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis 2010;13:144–50.PubMedCrossrefWeb of ScienceGoogle Scholar

  • [17]

    McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthr Rheum 2001;45:453–61.CrossrefGoogle Scholar

  • [18]

    Williams VS, Smith MY, Fehnel SE. The validity and utility of the BPI interference measures for evaluating the impact of osteoarthritic pain. J Pain Symptom Manage 2006;31:48–57.PubMedCrossrefGoogle Scholar

  • [19]

    Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford) 1999;38:870–7.PubMedCrossrefGoogle Scholar

  • [20]

    Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15:1833–40.Google Scholar

  • [21]

    Strand V, Kosinski M, Gnanasakthy A, Mallya U, Mpofu S. Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds. Health Qual Life Outcomes 2014;12:31.CrossrefPubMedWeb of ScienceGoogle Scholar

  • [22]

    Conaghan PG, Peloso PM, Everett SV, Rajagopalan S, Black CM, Mavros P, Arden NK, Phillips CJ, Rannou F, van de Laar MA, Moore RA, Taylor SD. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford) 2014, pii: keu332 [Epub ahead of print].PubMedGoogle Scholar

  • [23]

    Moore RA, Derry S, Simon LS, Emery P. Nonsteroidal anti-inflammatory drugs, gastroprotection, and benefit-risk. Pain Pract 2013 (accessed at http://onlinelibrary.wiley.com/doi/10.1111/papr.12100/pdf).Web of SciencePubMed

  • [24]

    Stam W, Jansen J, Taylor S. Efficacy of etoricoxib, celecoxib, lumiracoxib, nonselective NSAIDs, and acetaminophen in osteoarthritis: a mixed treatment comparison. Open Rheumatol J 2012;6:6–20.CrossrefGoogle Scholar

  • [25]

    Finney A, Porcheret M, Grime J, Jordan KP, Handy J, Healey E, Ryan S, Jester R, Dziedzic K. Defining the content of an opportunistic osteoarthritis consultation with primary health care professionals: a Delphi consensus study. Arthritis Care Res 2013;65:962–8.Web of ScienceCrossrefGoogle Scholar

About the article

Merck & Co., Inc., RY34-A470, Rahway, NJ 07065, USA. Tel.: +1 732 594 4551; fax: +1 732 594 3178.


Received: 2015-12-15

Revised: 2016-07-20

Accepted: 2016-07-21

Published Online: 2016-10-01

Published in Print: 2016-10-01


Disclosures: This work was supported by Merck & Co., Inc., Kenilworth, NJ, USA.

Conflict of interest: Relationships relevant to this manuscript: P.M. Peloso, D. F. Gates, W. L. Straus, Z. Popmihajlov are currently or were employees of Merck & Co., Inc. and may own stock/stock options in Merck & Co., Inc. W-J Chen, H-Y Lin were investigators for the study, which was sponsored by Merck & Co., Inc. R.A. Moore has no competing interests related to this work.

Author contributions: All authors discussed the results and commented on the results and manuscript. P.M. Peloso, W-J Chen, H-Y Lin, D.F. Gates, W.L. Straus, Z. Popmihajlov and R.A. Moore made substantial contributions to: (1) study conception and design and analysis and interpretation of data; (2) drafting the article and revising it critically for important intellectual content; and (3) final approval of the version to be published.

Ethical issues: The study was conducted in 16 hospitals in Taiwan and the protocol was not registered. The study protocol and procedures were approved by the respective Ethics Review Boards. Written consent was obtained prior to subjects undergoing any study procedures (16).


Citation Information: Scandinavian Journal of Pain, Volume 13, Issue 1, Pages 175–181, ISSN (Online) 1877-8879, ISSN (Print) 1877-8860, DOI: https://doi.org/10.1016/j.sjpain.2016.07.002.

Export Citation

© 2016 Scandinavian Association for the Study of Pain.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
E. V. Zonova and A. E. Karateev
Modern Rheumatology Journal, 2018, Volume 12, Number 4, Page 47
[2]
Winfried Häuser, Patrick Welsch, Petra Klose, Sheena Derry, Sebastian Straube, Philip J Wiffen, and R Andrew Moore
Cochrane Database of Systematic Reviews, 2018
[3]
Patrick Welsch, Kathrin Bernardy, Sheena Derry, R Andrew Moore, and Winfried Häuser
Cochrane Database of Systematic Reviews, 2018

Comments (0)

Please log in or register to comment.
Log in