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Sensitivity to Change of Patient-Preference Measures for Pain in Patients With Knee Osteoarthritis: Data From Two Trials.

ABSTRACT: OBJECTIVE:In osteoarthritis (OA) clinical trials, a pain measure that is most sensitive to change is considered optimal. We compared sensitivity to change of patient-reported pain outcomes, including a patient-preference measure (where the patient nominates an activity that aggravates their pain). METHODS:We used data from 2 trials of patients with confirmed (American College of Rheumatology criteria) knee OA: a trial of brace treatment for patellofemoral OA, and a trial of intraarticular steroids in knee OA. Both trials reported an improvement in pain following treatment. Participants rated pain on a 100-mm visual analog scale (VAS), in the activity that caused them the most knee pain (VASNA ), as well as completing questions on overall knee pain and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were also calculated from the KOOS. Standardized changes in each outcome were generated between treatment and control after 6 weeks intervention in the BRACE trial, and 1-2 weeks following intervention in the steroid trial. RESULTS:The VASNA produced standardized changes following treatment that were at least as large as other pain outcomes. In the BRACE trial, the between-groups standardized change with the VASNA was -0.63, compared with the KOOS pain subscale change of -0.33, and pain in the last week VAS change of -0.56. In the steroid study, within-group change following treatment in the VASNA was -0.60, compared to the last week VAS change of -0.51, and KOOS pain subscale change of -0.58. CONCLUSION:Pain on nominated activity appears to be at least as, and in some cases more, sensitive to change than the KOOS/WOMAC questionnaire.

SUBMITTER: Parkes MJ

PROVIDER: S-EPMC5025729 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Sensitivity to Change of Patient-Preference Measures for Pain in Patients With Knee Osteoarthritis: Data From Two Trials.

Parkes Matthew J MJ Callaghan Michael J MJ O'Neill Terence W TW Forsythe Laura M LM Lunt Mark M Felson David T DT

Arthritis care & research 20160728 9

<h4>Objective</h4>In osteoarthritis (OA) clinical trials, a pain measure that is most sensitive to change is considered optimal. We compared sensitivity to change of patient-reported pain outcomes, including a patient-preference measure (where the patient nominates an activity that aggravates their pain).<h4>Methods</h4>We used data from 2 trials of patients with confirmed (American College of Rheumatology criteria) knee OA: a trial of brace treatment for patellofemoral OA, and a trial of intraa ...[more]

PMID: 26713415

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Project description:Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials showed significantly improved total effectiveness rates (risk ratio [Formula: see text] 1.12; 95% CI, 1.05 to 1.19; [Formula: see text] 0.0003). In addition, TCM showed a lower risk of adverse events than standard western treatments. This evidence suggests that TCM is safe and effective for improving pain, function, and wellness in treatments of knee OA. However, there is inherent clinical heterogeneity (diverse TCM formulations, controls, and treatment regimens) among the included trials. Despite these limitations, the potential analgesic effects of TCM warrant further methodologically rigorous research to determine the clinical implications of TCM on pain management in knee OA.

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.

Dataset Information

Sensitivity to Change of Patient-Preference Measures for Pain in Patients With Knee Osteoarthritis: Data From Two Trials.

Publications

Sensitivity to Change of Patient-Preference Measures for Pain in Patients With Knee Osteoarthritis: Data From Two Trials.

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