Cited by 171Fibromyalgia and Chronic Fatigue Syndrome ResearchMusculoskeletal pain and rehabilitationStatistical Methods in Clinical Trials

Estimation of minimum clinically important difference for pain in fibromyalgia

Mease, Philip J., Spaeth, Michael, Clauw, Daniel J., Arnold, Lesley M., Bradley, Laurence A., Russell, I. Jon, Kajdasz, Daniel K., Walker, Daniel J. +1 more·2011·Arthritis Care & Research

Abstract

Objective: To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia. Methods: Data were pooled across 12‐week treatment periods from 4 randomized, double‐blind, placebo‐controlled studies designed to evaluate the safety and efficacy of duloxetine for the treatment of fibromyalgia. Each study enrolled subjects with American College of Rheumatology–defined fibromyalgia who presented with moderate to severe pain. The MCIDs for the BPI average pain item score and the BPI severity score (the mean of the BPI pain scale values: right now, average, least, and worst) were estimated by anchoring against the Patient's Global Impressions of Improvement scale. Results: The anchor‐based MCIDs for the BPI average pain item and severity scores were 2.1 and 2.2 points, respectively. These MCIDs correspond to 32.3% and 34.2% reductions from baseline in scores. Conclusion: In these analyses, the MCIDs for several pain measures obtained from the BPI were similar (∼2 points) and corresponded to a 30–35% improvement from baseline to end point. These findings may be beneficial for use in designing clinical trials in which the BPI is used to evaluate improvements in pain severity.

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Crossref · 10.1002/acr.20449

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  • The MCID for the BPI average pain severity subscale is 2.1 points, an improvement of 32.3% from baseline.

    “The MCID for the BPI- average pain severity subscale was set at 2.1 points, an improvement of 32.3% from baseline [30].”

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Authors
Mease, P. J., Spaeth, M., Clauw, D. J., Arnold, L. M., Bradley, L. A., Russell, I. J., Kajdasz, D. K., Walker, D. J., & Chappell, A. S.
Affiliations
  • University of Washington (US)
  • University of Michigan (US)
  • University of Cincinnati (US)
  • University of Alabama at Birmingham (US)
  • The University of Texas at San Antonio Health Science Center (US)
  • Trevi Therapeutics (United States) (US)
  • Eli Lilly (United States) (US)
  • Indiana University School of Medicine (US)
Venue
Arthritis Care & Research
Publisher
Wiley
Published
2011-05-31
Volume
63
Issue
6
Pages
821-826
ISSN
  • 0893-7524 (ISSN-L)
  • 2151-464X
  • 2151-4658
OpenAlex
W2070104085
Cited by
171
References
33
Citations by year
2026: 16 · 2025: 15 · 2024: 9 · 2023: 20 · 2022: 15 · 2021: 32 · 2020: 10 · 2019: 9 · 2018: 7 · 2017: 4 · 2016: 5 · 2015: 1 · 2014: 11 · 2013: 9 · 2012: 4
FWCI
5.69
Type
journal article
Language
en
Open access
closed
Locations
  • Arthritis Care & Research (publishedVersion)
  • PubMed (publishedVersion)
  • Deep Blue (University of Michigan) (submittedVersion)
Funders
Eli Lilly and Company
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
minimal clinically important difference, fibromyalgia, pain, Brief Pain Inventory, duloxetine, pain intensity, anchor-based estimation, clinical trial design, treatment response
MeSH terms
Duloxetine Hydrochloride, Adult, Double-Blind Method, Female, Fibromyalgia, Humans, Male, Middle Aged, Pain, Pain Measurement, Severity of Illness Index, Thiophenes

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