Background and Purpose: To determine intra-session test-retest reliability, agreement and minimum detectable change (MDC) of the 30 CST across three tests in people with knee osteoarthritis (OA). Methods:A test-retest reliability study was performed with 93 people with mild radiological knee OA. Participants were asked to complete three attempts of the 30 CST 1-2 min apart according to a standardised protocol. Participants completed three attempts on two occasions: baseline and 6 months later. Change between tests within each session was assessed with ANOVA's and post-hoc t-tests. Reliability was assessed with intra-class correlation coefficients (ICC [2,1] ). Measurement error was expressed as MDC for an individual (MDC ind ) and a group (MDC group ).Floor effects were considered present if more than 15% of participants scored zero for a test.Results: Scores increased by 0.5 and 0.8 stands between the first and second test (p < 0.05) at the baseline and 6-month assessments respectively, and then stabilised between the second the third tests at the baseline assessment (p > 0.05) or decreased (0.3 stands) at the 6-month assessment (p < 0.05). Scores demonstrated excellent reliability (ICCs >0.9). MDC ind was approximately 2.5 stands and MDC group was 0.3-0.4 stands. No floor effects were apparent.Discussion: The 30CST demonstrated a practice effect between the first and second tests, which was no longer apparent by the third test. Despite this, scores demonstrated excellent intra-session reliability. MDC estimates provide clinicians and researchers with the smallest change that can be detected by the instrument beyond measurement error for individuals and groups in community-dwelling adults with knee OA.
IntroductionSymptomatic knee osteoarthritis (OA) is common. Advanced knee OA is successfully treated with joint replacement surgery, but effectively managing mild to moderate knee OA can be difficult. Angiogenesis increases with OA and might contribute to pain and structural damage. Modifying angiogenesis is a potential treatment pathway for OA. The aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature arising from the genicular arterial branches improves knee pain, physical function and quality of life in people with mild to moderate symptomatic knee OA.Methods and analysisThe study is a single centre, parallel-arm, double-blinded (participant and assessor), randomised controlled superiority trial with 1:1 random block allocation. Eligible participants have mild to moderate symptomatic knee OA and will be randomly assigned to receive either embolisation of aberrant knee neovasculature of genicular arterial branches or a placebo intervention. Outcome measures will be collected prior to the intervention and again 1, 6 and 12 months postintervention. The primary outcome is change in knee pain between baseline and 12 month assessment as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include change in self-reported physical function (KOOS), self-reported quality of life (KOOS, EuroQol: EQ-5D-5L), self-reported knee joint stiffness (KOOS), self-reported global change, 6 min walk test performance, and 30 s chair-stand test performance. Intention-to-treat analysis will be performed including all participants as randomised. To detect a mean between group difference in change pain of 20% at the one year reassessment with a two-sided significance level of α=0.05 and power of 80% using a two-sample t-test, we require 29 participants per arm which allows for 20% of participants to drop out.Ethics and disseminationBarwon Health Human Research Ethics Committee, 30 May 2016, (ref:15/101). Study results will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberUniversal trial number U1111-1183-8503, Australian New Zealand Clinical Trials Registry, ACTRN12616001184460, approved 29 August 2016.
AimsThis study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure.MethodsA total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests.ResultsOverall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group.ConclusionTAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made.Level of evidence: ICite this article: Bone Jt Open 2023;4(3):158–167.
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