Dataset Information

Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis.

ABSTRACT: OBJECTIVE:In rheumatoid arthritis, composite outcomes constructed from a combination of outcome measures are widely used to enhance responsiveness (sensitivity to change) and comprehensively summarize response. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain is the primary outcome measure in many osteoarthritis (OA) trials. Information from other outcomes, such as rescue medication use and other WOMAC subscales, could be added to create composite outcomes, but the sensitivity of such a composite has not been tested. METHODS:We used data from a completed trial of tanezumab for knee OA (NCT00733902). The WOMAC questionnaire and rescue medication use were measured at several timepoints, up to 16 weeks. Pain and rescue medication outcomes were standardized and combined into 3 composite outcomes through principal components analysis to produce 1 score (composite outcome) and their responsiveness was compared to WOMAC pain, the standard. We pooled all treatment doses of tanezumab into 1 treatment group, for simplicity, and compared this to the control group (placebo). RESULTS:The composite outcomes showed modestly, but not statistically significantly greater responsiveness when compared to WOMAC pain alone. Adding information on rescue medication to the composite improved responsiveness. While improvements in sensitivity were modest, the required sample sizes for trials using composites was 20-40% less than trials using WOMAC pain alone. CONCLUSION:Combining information from related but distinct outcomes considered relevant to a particular treatment improved responsiveness, could reduce sample size requirements in OA trials, and might offer a way to better detect treatment efficacy in OA trials.

SUBMITTER: Parkes MJ

PROVIDER: S-EPMC6076998 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis.

Parkes Matthew J MJ Callaghan Michael J MJ Tive Leslie L Lunt Mark M Felson David T DT

The Journal of rheumatology 20180501 9

<h4>Objective</h4>In rheumatoid arthritis, composite outcomes constructed from a combination of outcome measures are widely used to enhance responsiveness (sensitivity to change) and comprehensively summarize response. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain is the primary outcome measure in many osteoarthritis (OA) trials. Information from other outcomes, such as rescue medication use and other WOMAC subscales, could be added to create composite outcomes, but ...[more]

PMID: 29717032

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Project description:IntroductionRecent research showed that physical activity (PA)-adjusted pain measures were more strongly associated with radiographic osteoarthritis (OA) severity than an unadjusted pain measure. This exploratory study examined whether PA-adjusted pain measures were more closely associated with other key OA-related measures, compared to unadjusted pain scores.MethodParticipants were 122 Veterans (mean age = 61.2 years, 88.5% male) with knee OA. Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores were adjusted for accelerometer-derived daily: (1) step counts, (2) minutes of any activity, (3) minutes of moderate or greater intensity activity, (4) minutes of light intensity activity, and (5) energy expenditure. Partial correlations, adjusted for age, sex, and body mass index, estimated associations of unadjusted and PA-adjusted WOMAC pain scores with functional assessments (6-minute walk test, 8-foot walk test, chair stand test, satisfaction with physical function), fatigue (Brief Fatigue Inventory), and anxiety/depressive symptoms (single item).ResultsSignificant (p < 0.05) associations were found in 29 of 36 of models. For the four function-related assessments, step count and energy expenditure-adjusted WOMAC pain scores had stronger associations (partial rs = 0.24-0.48) than WOMAC pain score (partial rs = 0.19-0.25). For fatigue and anxiety/depressive symptoms, WOMAC pain score had stronger, positive associations than most PA-adjusted pain scores. Of the PA-adjusted measures, the strongest associations overall were observed for step count and energy expenditure.ConclusionPA-adjusted pain scores may have particular value for OA studies involving functional assessments, whereas unadjusted WOMAC pain scores are more closely associated with psychological symptoms. This has implications for measurement in clinical OA studies.Trial registrationNCT01058304 KEY POINTS: • Among patents with osteoarthritis, physical activity-adjusted pain measures (particularly those adjusted for step count and energy expenditure) were more strongly associated with measures of physical function, compared to unadjusted pain scores, whereas unadjusted pain score was more strongly associated with a measure of psychological symptoms. • In clinical osteoarthritis research, the most appropriate or sensitive symptom measure (pain vs. physical activity-adjusted pain) may depend on the type of intervention or outcome being studied.

Project description:BackgroundThe prevalence of knee osteoarthritis is traditionally based on radiographic findings, but magnetic resonance imaging is now being used to provide better visualization of bone, cartilage, and soft tissues as well as the patellar compartment. The goal of this study was to estimate the prevalences of knee features defined on magnetic resonance imaging in a population and to relate these abnormalities to knee osteoarthritis severity scores based on radiographic findings, physical functioning, and reported knee pain in middle-aged women.MethodsMagnetic resonance images of the knee were evaluated for the location and severity of cartilage defects, bone marrow lesions, osteophytes, subchondral cysts, meniscal and/or ligamentous tears, effusion, and synovitis among 363 middle-aged women (724 knees) from the Michigan Study of Women's Health Across the Nation. These findings were related to Kellgren-Lawrence osteoarthritis severity scores from radiographs, self-reported knee pain, self-reported knee injury, perception of physical functioning, and physical performance measures to assess mobility. Radiographs, physical performance assessment, and interviews were undertaken at the 1996 study baseline and again (with the addition of magnetic resonance imaging assessment) at the follow-up visit during 2007 to 2008.ResultsThe prevalence of moderate-to-severe knee osteoarthritis changed from 3.7% at the baseline assessment to 26.7% at the follow-up visit eleven years later. Full-thickness cartilage defects of the medial, lateral, and patellofemoral compartments were present in 14.5% (105 knees), 4.6% (thirty-three knees), and 26.2% (190 knees), respectively. Synovitis was identified in 24.7% (179) of the knees, and joint effusions were observed in 70% (507 knees); 21.7% (157) of the knees had complex or macerated meniscal tears. Large osteophytes, marked synovitis, macerated meniscal tears, and full-thickness tibial cartilage defects were associated with increased odds of knee pain and with 30% to 40% slower walking and stair-climbing times.ConclusionsMiddle-aged women have a high prevalence of moderate-to-severe knee osteoarthritis corroborated by strong associations with cartilage defects, complex and macerated meniscal tears, osteophytes and synovitis, knee pain, and lower mobility levels.

Project description:AbstractPain is one of the most prominent symptoms of osteoarthritis. However, there is often discordance between the pain experienced by individuals with osteoarthritis and the degree of articular pathology. This suggests that individual differences, including genetic variability in the central processing of nociceptive stimuli, may impact the presentation of osteoarthritis. Here, we show that the single nucleotide polymorphism rs16868943 in the collagen gene COL11A2 is significantly associated with lowered heat pain tolerance on the arm in participants with knee osteoarthritis (P = 1.21 × 10−6, P = 0.0053 after Bonferroni correction, beta = −3.42). A total of 161 knee osteoarthritis participants were included and evaluated for heat, punctate and pressure pain sensitivity of the affected knee and the ipsilateral arm. Each participant was genotyped for 4392 single nucleotide polymorphisms in genes implicated in pain perception, inflammation and mood and tested for association with pain sensitivity. The minor A allele of single nucleotide polymorphism rs16868943 was significantly associated with lower arm heat pain tolerance after correction for age, gender, race, and study site. This single nucleotide polymorphism was also nominally associated with other measures of heat pain sensitivity, including lowered knee heat pain tolerance (P = 1.14 × 10−5, P = 0.05 after Bonferroni correction), lowered arm heat pain threshold (P = 0.0039, uncorrected) and lowered knee heat pain threshold (P = 0.003, uncorrected). Addition of genotypes from 91 participants without knee pain produced a significant interaction between knee osteoarthritis status and the rs16868943 single nucleotide polymorphism in heat pain tolerance (P = 1.71 × 10−5), such that rs16868943 was not associated with heat pain tolerance in participants without knee pain (P = 0.12, beta = 1.3). This is the first study to show genetic association with heat pain tolerance in individuals with osteoarthritis. The association is specific to participants who have already developed knee osteoarthritis, suggesting that the COL11A2 gene, which has previously been associated with familial osteoarthritis, may play a role in pain sensitization after the development of osteoarthritis.

Dataset Information

Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis.

Publications

Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis.

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