Knee pain

膝盖疼痛
  • 文章类型: Journal Article
    目的:探讨股四头肌力量与膝关节疼痛的关系。
    方法:这项横断面研究基于1999-2000年和2001-2002年国家健康和营养检查调查的数据。
    方法:这是一项基于社区的研究。
    方法:这项研究包括2,619名成年人,他们有膝关节疼痛的完整数据,股四头肌力量,和协变量。
    方法:不适用。
    方法:自我报告膝关节疼痛。
    结果:这项研究包括2,619人,其中1,287人(52.66%)为女性,1,543人(81.66%)为墨西哥裔美国人。平均±标准差年龄为62.48±9.71岁。在调整协变量后,膝关节疼痛的几率随着股四头肌力量每增加20N/m而降低(赔率比,0.87;95%CI,0.81-0.94)。股四头肌力量上四分位数的个体膝关节疼痛的几率低于下四分位数的个体(Q4与Q1[参考]:赔率比,0.28,95%CI,0.15-0.52;ptrend=0.006)。非线性分析表明膝关节疼痛的L形关联。亚组分析显示没有显著的相互作用,除了性别(pinteraction=0.046)。性别互动的重要性表明仅在女性中存在相关性。
    结论:结果显示股四头肌力量与膝关节疼痛之间呈负相关。按性别进行的亚组分析表明,这种反比关系在女性亚组中具有统计学意义,而在男性亚组中没有统计学意义。
    OBJECTIVE: To investigate the association of quadriceps strength with the presence of knee pain.
    METHODS: This cross-sectional study was based on data from the 1999-2000 to 2001-2002 National Health and Nutrition Examination Survey.
    METHODS: This was a community-based study.
    METHODS: This study included 2619 adults with complete data for knee pain, quadriceps strength, and covariates.
    METHODS: Not applicable.
    METHODS: Self-reported knee pain.
    RESULTS: This study included 2619 individuals, 1287 (52.66%) of whom were women and 1543 (81.66%) identified as Non-Hispanic White. The mean ±standard deviation age was 62.48±9.71 years. After adjusting for covariates, the odds of knee pain decreased with every 20 N/m increase in quadriceps strength (odds ratio, 0.87; 95% confidence interval, 0.81-0.94). Individuals in the upper quartile of quadriceps strength had lower odds of knee pain than those in the lower quartile (Q4 vs Q1 [reference]: odds ratio, 0.28, 95% confidence interval, 0.15-0.52; Ptrend=.006). Nonlinear analyses indicated L-shaped associations for knee pain. The subgroup analyses showed no significant interactions, except for sex (Pinteraction=.046). The significance of the sex interaction indicated a correlation exclusively in women.
    CONCLUSIONS: The results demonstrated an inverse association between quadriceps strength and the presence of knee pain. The subgroup analysis by sex showed that this inverse relationship was statistically significant in the women but not in the men subgroup.
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  • 文章类型: Journal Article
    目的:评价轻至重度膝骨关节炎患者行膝动脉栓塞(GAE)治疗12个月后的安全性和有效性。
    方法:这项前瞻性单中心研究包括膝关节骨性关节炎>1年、保守治疗无效>6个月后中度至重度疼痛的患者。评估基线成像特征以确定Kellgren-Lawrence(KL)等级和磁共振成像(MOAKS)评分。使用150-350μm栓塞聚乙烯醇颗粒进行GAE。视觉模拟量表(VAS)和西安大略省和麦克马斯特大学骨关节炎指数(WOMAC)评分用于评估膝关节疼痛,刚度,以及基线和随访时的功能。主要终点是12个月时VAS和WOMAC评分的变化。
    结果:纳入33例患者(n=37膝),年龄66.6±8.7岁。患者分为两组:轻度至中度骨关节炎(n=28,KL2-3级)和重度骨关节炎(n=9,KL4级)。所有患者均成功进行了GAE,无重大不良事件。膝状动脉的三到六个分支被栓塞。轻度至中度组的平均VAS和WOMAC评分显着降低(基线时6.6与3.0在12个月和49.4与分别为27.4,所有P<0.001)。重度组的平均VAS和WOMAC评分在12个月时显著下降(7.3vs.4.4和58.1vs.40.6,分别所有P<0.001)。
    结论:GAE是一种耐受性良好且有效的治疗方法,可显著改善轻度至重度膝骨关节炎患者的疼痛症状和功能。
    OBJECTIVE: To evaluate the safety and efficacy of genicular artery embolization (GAE) in patients with mild-to-severe knee osteoarthritis up to 12 months after GAE.
    METHODS: This prospective single-center study included patients who had knee osteoarthritis for >1 year with moderate-to-severe pain after failed conservative treatment for >6 months. Baseline imaging features were evaluated to determine Kellgren-Lawrence (KL) grade and magnetic resonance imaging (MOAKS) scores. GAE was performed using 150-350 μm embolic polyvinyl alcohol particles. The visual analog scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were used to evaluate knee pain, stiffness, and function at baseline and follow-up. The primary endpoints were changes in VAS and WOMAC scores at 12 months.
    RESULTS: Thirty-three patients (n = 37 knees) aged 66.6 ± 8.7 years were enrolled. The patients were categorized into two groups: mild-to-moderate osteoarthritis (n = 28, KL grades 2-3) and severe osteoarthritis (n = 9, KL grade 4). GAE was successfully performed in all patients, with no major adverse events. Three to six branches of the genicular artery were embolized. The mean VAS and WOMAC scores in the mild-to-moderate group significantly decreased (6.6 at baseline vs. 3.0 at 12 months and 49.4 vs. 27.4, respectively, all P < 0.001). The mean VAS and WOMAC scores in the severe group significantly decreased at 12 months (7.3 vs. 4.4 and 58.1 vs. 40.6, respectively, all P < 0.001).
    CONCLUSIONS: GAE is a well-tolerated and effective treatment that significantly improves pain symptoms and function in patients with mild-to-severe knee osteoarthritis.
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  • 文章类型: Systematic Review
    目的:确定和描述预测膝骨关节炎患者膝关节疼痛的现有模型。
    方法:电子数据库PubMed,EMBASE,CINAHL,WebofScience,和CochraneLibrary从成立到2023年5月进行了搜索,以开发和验证预测膝关节骨关节炎患者膝关节疼痛的预测模型。两名审稿人独立筛选标题,摘要,和全文资格,并提取数据。使用PROBAST评估偏倚风险。通过基于CHARMS的数据提取表提取符合条件的文章的数据。证据质量按等级进行分级。结果用描述性统计进行总结。
    结果:搜索确定了2693条记录。纳入了16篇报告26个预测模型的文章(n=9),其他(n=7),进展(n=5),持久性(n=2),事件(n=1),频繁(n=1),和膝关节疼痛的耀斑(n=1)。大多数研究(94%)存在高偏倚风险。通过在0.62至0.81范围内的AUROC评估模型辨别。最常见的预测因素是年龄,BMI,性别,基线疼痛,和关节空间宽度。只有频繁的膝关节疼痛具有中等质量的证据;所有其他类型的膝关节疼痛的证据质量均较低。
    结论:有许多膝关节骨性关节炎患者膝关节疼痛的预测模型确实显示出了希望。然而,临床可扩展性,适用性,在模型开发过程中应考虑预测工具的可解释性。
    OBJECTIVE: To identify and describe existing models for predicting knee pain in patients with knee osteoarthritis.
    METHODS: The electronic databases PubMed, EMBASE, CINAHL, Web of Science, and Cochrane Library were searched from their inception to May 2023 for any studies to develop and validate a prediction model for predicting knee pain in patients with knee osteoarthritis. Two reviewers independently screened titles, abstracts, and full-text qualifications, and extracted data. Risk of bias was assessed using the PROBAST. Data extraction of eligible articles was extracted by a data extraction form based on CHARMS. The quality of evidence was graded according to GRADE. The results were summarized with descriptive statistics.
    RESULTS: The search identified 2693 records. Sixteen articles reporting on 26 prediction models were included targeting occurrence (n = 9), others (n = 7), progression (n = 5), persistent (n = 2), incident (n = 1), frequent (n = 1), and flares (n = 1) of knee pain. Most of the studies (94%) were at high risk of bias. Model discrimination was assessed by the AUROC ranging from 0.62 to 0.81. The most common predictors were age, BMI, gender, baseline pain, and joint space width. Only frequent knee pain had a moderate quality of evidence; all other types of knee pain had a low quality of evidence.
    CONCLUSIONS: There are many prediction models for knee pain in patients with knee osteoarthritis that do show promise. However, the clinical extensibility, applicability, and interpretability of predictive tools should be considered during model development.
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  • 文章类型: Journal Article
    目的:代谢综合征(MetS)的特征是中心性肥胖与代谢异常的聚集。我们旨在描述以一般人群为基础的中年人在10-13年内的MetS和MetS轨迹与膝关节症状的关联。
    方法:空腹血液生化,在儿童成人健康决定因素(CDAH)-1研究期间(年份:2004-6;n=2447;平均年龄:31.48±2.60)和10-13年后(年份:2014-2019;n=1549;平均年龄:44±2.90)收集腰围和血压测量值.根据国际糖尿病联合会(IDF)的定义,参与者被定义为患有MetS。在CDAH-3(成年中期)使用西安大略省和麦克马斯特大学骨关节炎指数(WOMAC)量表评估膝关节症状。
    结果:在10-13年间,MetS的患病率从年轻成年期的8%(女性:52.06%)增加到成年中期的13%(女性:53.78%)。成年中期存在MetS与成年中期的膝关节症状相关[均值比(RoM):1.33;95CI:1.27,1.39]。确定了四个MetS轨迹-\“无MetS\”(85.01%);\“改进的MetS\”(2.14%),\'事件警报\'(8.81%),和\'持久性MES,(4.04%)。与\'NoMetS\'相比,\'持久性MetS\'[RoM:1.15;95CI:1.06,1.25],“突发事件事件”[RoM:1.56;95CI:1.48,1.65],和“改善症状”[RoM:1.22;95CI:1.05,1.41]与较高的膝关节症状相关。值得注意的是,在成年中期,“事件性代谢综合征”与膝关节症状[RoM:1.56;95CI:1.48,1.65]和疼痛[RoM:1.52;95CI:1.37,1.70]密切相关。
    结论:在这个中年人样本中,MetS与膝关节症状之间存在显著正相关.相对于那些在任何一个生命阶段都没有MetS的人,与成年后患MetS的患者相比,成年后患MetS的患者平均膝关节疼痛评分的升高更为明显.
    OBJECTIVE: Metabolic syndrome (MetS) is characterised by the clustering of central obesity with metabolic abnormalities. We aimed to describe the association of MetS and trajectories of MetS over 10-13 years with knee symptoms in general population-based middle-aged adults.
    METHODS: Fasting blood biochemistry, waist circumference and blood pressure measures were collected during Childhood Determinants of Adult Health (CDAH)-1 study (year:2004-6; n = 2447; mean age:31.48 ± 2.60) and after 10-13 year at CDAH-3 (year:2014-2019; n = 1549; mean age:44 ± 2.90). Participants were defined as having MetS as per International Diabetes Federation (IDF) definition. Knee symptoms were assessed using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale at CDAH-3 (mid-adulthood).
    RESULTS: The prevalence of MetS increased from 8 % at young adulthood (female:52.06 %) to 13 % in mid-adulthood (female:53.78 %) over 10-13 years. Presence of MetS at mid-adulthood was associated with knee symptoms at mid-adulthood [ratio of means (RoM): 1.33; 95%CI:1.27,1.39]. Four MetS trajectories were identified-\'No MetS\' (85.01 %); \'Improved MetS\' (2.14 %), \'Incident MetS\' (8.81 %), and \'Persistent MetS, (4.04 %). Compared to \'No MetS\', \'Persistent MetS\' [RoM:1.15; 95%CI:1.06,1.25], \'Incident MetS\' [RoM:1.56; 95%CI:1.48,1.65], and \'Improved MetS\' [RoM:1.22; 95%CI:1.05,1.41] was associated with higher knee symptoms. Notably, \'Incident MetS\' was strongly associated with knee symptoms [RoM: 1.56; 95%CI:1.48,1.65] and pain [RoM:1.52; 95%CI:1.37,1.70] at mid-adulthood.
    CONCLUSIONS: In this sample of middle-aged adults, there was a significant positive association between MetS and knee symptoms. Relative to those without MetS at either life stage, the elevation in mean knee pain scores was more pronounced for those who developed MetS after young adulthood than for those who had MetS in young adulthood.
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  • 文章类型: Journal Article
    这项研究旨在检查机器学习模型在预测膝关节疼痛进展方面的表现,功能衰退,和高风险个体的膝骨关节炎(OA)的发病率,自动机器学习(AutoML)用于自动化预测过程。
    我们的AutoML集成预测过程分为四个阶段。第1阶段-数据准备:提取并使用骨关节炎倡议(OAI)研究中的3200名合格个体的数据,这些个体在基线就诊时被认为是膝OA的高风险。具体来说,来自OAI研究的1094个变量用于预测膝关节疼痛的变化,物理功能,和膝关节OA的发生率(即在9年期间首次出现频繁的膝关节症状和明确的胫骨骨赘(Kellgren和Lawrence≥2级))。阶段2-模型训练:AutoML方法用于自动训练九种广泛使用的机器学习(ML)模型。第3阶段-模型测试:AutoML方法用于自动测试ML模型的性能。阶段4-重要输入变量的选择:AutoML方法自动计算所有输入变量的重要性得分并识别最重要的变量,使用置换特征重要性的技术。
    使用AutoML方法,加权集成模型和CatBoost模型在所有9个ML模型中表现最佳。对于每年每个结果的预测,确定了五个最重要的输入变量,其中大部分来自自我报告的问卷调查和影像学报告.
    AutoML方法在自动化使用ML模型预测膝关节OA相关结果的长期变化的过程中显示出潜力。它的使用可以支持ML解决方案的部署,促进提供个性化干预措施,以防止膝关节健康恶化和膝关节OA的发生。
    UNASSIGNED: This study aimed to examine the performance of machine learning models in predicting the progression of knee pain, functional decline, and incidence of knee osteoarthritis (OA) in high-risk individuals, with automated machine learning (AutoML) being used to automate the prediction process.
    UNASSIGNED: There were four stages in the process of our AutoML-integrated prediction. Stage 1-Data preparation: The data of 3200 eligible individuals in the Osteoarthritis Initiative (OAI) study who were considered at high risk of knee OA at the baseline visit were extracted and used. Specifically, 1094 variables from the OAI study were used to predict the changes in knee pain, physical function, and incidence of knee OA (i.e. the first occurrence of frequent knee symptoms and definite tibial osteophytes (Kellgren and Lawrence grade ≥2)) over a 9-year period. Stage 2-Model training: The AutoML approach was used to automatically train nine widely used machine learning (ML) models. Stage 3-Model testing: The AutoML approach was used to automatically test the performance of the ML models. Stage 4-Selection of important input variables: The AutoML approach automated the process of computing the importance scores of all input variables and identifying the most important ones, using the technique of permutation feature importance.
    UNASSIGNED: Using the AutoML approach, the weighted ensemble model and the CatBoost model showed the best performance among all nine ML models. For the prediction of each outcome in each year, the five most important input variables were identified, most of which were obtained from self-reported questionnaire surveys and radiographic imaging reports.
    UNASSIGNED: The AutoML approach has shown potential in automating the process of using ML models to predict long-term changes in knee OA-related outcomes. Its use could support the deployment of ML solutions, facilitating the provision of personalized interventions to prevent the deterioration of knee health and incident knee OA.
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  • 文章类型: Journal Article
    背景:保持正常的髌骨对准对膝关节健康很重要。已发现个体股四头肌的激活改变与the骨对齐有关。然而,股四头肌的强度和被动刚度与髌骨对齐之间的关系仍未探索。
    方法:招募年龄在60至80岁之间的活动性膝关节疼痛患者。使用11点数字评定量表量化膝关节疼痛。使用Cybex测功机和股直肌被动刚度评估股四头肌强度。股外侧肌,采用剪切波超声弹性成像技术测量股内侧肌。使用MR成像评估髌骨对齐。线性回归用于检查股四头肌特性与the骨对齐之间的关系,并控制和不控制潜在的协变量。
    结果:对92名符合条件的参与者进行了评估(71.7%为女性,年龄:65.6±3.8岁;疼痛评分:4.6±2.0),大多数人在爬楼梯时膝盖疼痛(85.9%)。我们发现17%的髌骨侧向倾斜角可以解释为较低的股四头肌强度(调整后的R2=0.117;P<0.001),尤其是女性(R2=0.281;P<0.001;调整后的R2=0.211;P<0.001)。此外,较高的股外侧肌/中肌刚度比占髌骨外侧位移的12%(调整后的R2=0.112;P=0.008).
    结论:在患有膝关节疼痛的老年人中,股四头肌的力量和外侧至内侧头的相对刚度与髌骨对齐有关。这表明股四头肌无力和股四头肌外侧相对较硬可能是老年人髌骨畸形的危险因素。
    Maintaining normal patellar alignment is important for knee health. Altered activation of individual quadriceps muscles have been found related to patellar alignment. However, the relationships between strength and passive stiffness of the quadriceps and patellar alignment remains unexplored.
    Participants aged between 60 and 80 years with activity-induced knee pain were recruited. Knee pain was quantified using an 11-point numeric rating scale. Quadriceps strength was assessed using a Cybex dynamometer and passive stiffness of rectus femoris, vastus lateralis, and vastus medialis were measured by shear-wave ultrasound elastography. Patellar alignments were assessed using MR imaging. Linear regression was used to examine relationships between quadriceps properties and patellar alignments with and without controlling for potential covariates.
    Ninety-two eligible participants were assessed (71.7% females, age: 65.6 ± 3.8 years; pain scale: 4.6 ± 2.0), most of whom had knee pain during stair climbing (85.9%). We found that 17% of patellar lateral tilt angle could be explained by lower quadriceps strength (adjusted R2 = 0.117; P < 0.001), especially in females (R2 = 0.281; P < 0.001; adjusted R2 = 0.211; P < 0.001). In addition, a higher stiffness ratio of vastus lateralis/medialis accounted for 12% of patellar lateral displacement (adjusted R2 = 0.112; P = 0.008).
    Quadriceps strength and relative stiffness of lateral to medial heads are associated with patellar alignment in older adults with knee pain. It suggests that quadriceps weakness and relatively stiffer lateral quadriceps may be risk factors related to patellar malalignments in the elderly.
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  • 文章类型: Journal Article
    目的:虚弱是一种多系统综合征,其与症状性骨关节炎的关系已有报道。我们旨在在一个大型前瞻性队列中确定膝关节疼痛的轨迹,并描述基线时虚弱状态对9年以上疼痛轨迹的影响。
    方法:我们纳入了4419名参与者(平均年龄61.3岁,58%女性)来自骨关节炎倡议队列。参与者被归类为“无弱点”,\'脆弱前\',或基线处的“脆弱”,基于五个特征(即,无意的减肥,疲惫,弱能量,缓慢的步态速度,和低体力活动)。每年使用西安大略省和麦克马斯特大学骨关节炎指数疼痛子量表(0-20)从基线到9年评估膝关节疼痛。
    结果:在包括的参与者中,38.4%,55.4%,6.3%被归类为“无弱点”,\'脆弱前\',和“脆弱”,分别。确定了五个疼痛轨迹:“无痛”(n=1010,22.8%),“轻度疼痛”(n=1656,37.3%),“中度疼痛”(n=1149,26.0%),\'剧烈疼痛\'(n=477,10.9%),和“非常剧烈的疼痛”(n=127,3.0%)。与没有弱点的参与者相比,那些前期虚弱和虚弱的人更有可能有更严重的疼痛轨迹(前期虚弱:赔率比(ORs)1.5至2.1;脆弱:ORs1.5至5.0),在调整了潜在的混杂因素后。进一步的分析表明,虚弱和疼痛之间的关联主要是由疲惫驱动的,缓慢的步态速度,微弱的能量。
    结论:大约三分之二的中老年人体弱或体弱。虚弱在预测疼痛轨迹中的作用表明,虚弱可能是膝关节疼痛的重要治疗目标。
    OBJECTIVE: Frailty is a multisystem syndrome and its relationship with symptomatic osteoarthritis has been reported. We aimed to identify trajectories of knee pain in a large prospective cohort and to describe the effect of frailty status at baseline on the pain trajectories over 9 years.
    METHODS: We included 4419 participants (mean age 61.3 years, 58% female) from the Osteoarthritis Initiative cohort. Participants were classified as \"no frailty,\" \"pre-frailty,\" or \"frailty\" at baseline, based on 5 characteristics (ie, unintentional weight loss, exhaustion, weak energy, slow gait speed, and low physical activity). Knee pain was evaluated annually using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (0-20) from baseline to 9 years.
    RESULTS: Of the participants included, 38.4%, 55.4%, and 6.3% were classified as \"no frailty,\" \"pre-frailty,\" and \"frailty,\" respectively. Five pain trajectories were identified: \"No pain\" (n = 1010, 22.8%), \"Mild pain\" (n = 1656, 37.3%), \"Moderate pain\" (n = 1149, 26.0%), \"Severe pain\" (n = 477, 10.9%), and \"Very Severe pain\" (n = 127, 3.0%). Compared to participants with no frailty, those with pre-frailty and frailty were more likely to have more severe pain trajectories (pre-frailty: odds ratios [ORs] 1.5 to 2.1; frailty: ORs 1.5 to 5.0), after adjusting for potential confounders. Further analyses indicated that the associations between frailty and pain were mainly driven by exhaustion, slow gait speed, and weak energy.
    CONCLUSIONS: Approximately two-thirds of middle-aged and older adults were frail or pre-frail. The role of frailty in predicting pain trajectories suggests that frailty may be an important treatment target for knee pain.
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  • 文章类型: Journal Article
    为了方便患有膝关节疼痛的老年人进行锻炼和改善膝关节健康,我们提出了一个基于机器学习的下肢运动训练系统的设计,该系统具有三个主要组成部分:运动视频演示,实时运动反馈,并跟踪运动进度。在设计的早期阶段,我们旨在研究患有膝关节疼痛的老年人对纸质原型的看法,并调查可能影响他们对系统看法的因素.
    使用问卷对参与者(N=94)对系统的看法进行了横断面调查,评估他们对系统的感知效果,感知到的系统易用性,对系统的态度,并打算使用该系统。进行序数逻辑回归以检查参与者对系统的看法是否受到其人口统计学和临床特征的影响。身体活动水平,锻炼经验。
    参与者对感知陈述的反应表现出共识(≥75%)。年龄,性别,膝盖疼痛的持续时间,膝关节疼痛强度,运动疗法的经验,和技术支持锻炼计划的经验与参与者对系统的看法显著相关。
    我们的结果表明,该系统似乎有希望被老年人用于治疗膝盖疼痛。因此,需要开发基于计算机的系统并进一步研究其可用性,接受,和临床有效性。
    UNASSIGNED: To facilitate the older adults with knee pain to perform exercises and improve knee health, we proposed the design of a machine learning-based system for lower-limb exercise training that features three main components: video demonstration of exercises, real-time movement feedback, and tracking of exercise progress. At this early stage of design, we aimed to examine the perceptions of a paper-based prototype among older adults with knee pain and investigate the factors that may influence their perceptions of the system.
    UNASSIGNED: A cross-sectional survey of the participants\' (N = 94) perceptions of the system was conducted using a questionnaire, which assessed their perceived effects of the system, perceived ease of use of the system, attitude toward the system, and intention to use the system. Ordinal logistic regression was conducted to examine whether the participants\' perceptions of the system were influenced by their demographic and clinical characteristics, physical activity level, and exercise experience.
    UNASSIGNED: The participants\' responses to the perception statements exhibited consensus agreement (≥ 75%). Age, gender, duration of knee pain, knee pain intensity, experience with exercise therapy, and experience with technology-supported exercise programs were significantly associated with the participants\' perceptions of the system.
    UNASSIGNED: Our results demonstrate that the system appears promising for use by older adults to manage their knee pain. Therefore, it is needed to develop a computer-based system and further investigate its usability, acceptance, and clinical effectiveness.
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  • 文章类型: Journal Article
    背景:膝骨性关节炎(KOA)是一种常见的退行性关节疾病,可导致老年人群的残疾和疼痛。在63岁或以上的人群中,KOA的患病率约为30%。先前的研究已经报道了推拿治疗和中药配方杜霍吉生汤(DHJSD)治疗KOA的积极作用。本研究旨在评估除Tui-na外,口服DHJSD对KOA的附加治疗效果。
    方法:我们进行了前瞻性,随机化,对照临床试验。将70名患有KOA的研究对象以1:1的比例随机分配到治疗组和对照组。两组均接受了为期4周的八次Tui-na操作。DHJSD仅给予治疗组中的研究受试者。在治疗结束时(4周)使用WOMAC对主要结果测量进行评级。次要结果使用EQ-5D-5L评估,在治疗结束(第4周)和随访(第8周)时,使用5级EQ-5D版本的健康相关生活质量。
    结果:两组治疗结束时WOMAC评分无统计学差异。在第8周随访时,治疗组的平均WOMAC疼痛子量表评分明显低于对照组(平均差异,MD-1.8,95%CI-3.5至-0.02,P=0.048)。在第2周(MD0.74,95%CI0.05至1.42,P=0.035)和第8周(MD0.95,95%CI0.26至1.65,P=0.008),治疗组的平均WOMAC刚度子量表评分明显低于对照组。在第2周时,治疗组的平均EQ-5D指数值明显高于对照组(MD0.17,95%CI0.02至0.31,P=0.022)。两组的WOMAC评分和EQ-5D-5L分析均显示随时间有统计学意义的改善。试验期间未发现明显的不良反应。
    结论:DHJSD除了Tui-na操作外,还可以缓解KOA患者的疼痛,改善僵硬以及生活质量(QOL)。联合治疗通常是安全且耐受性良好的。试验注册该研究已在ClinicalTrials.gov注册(网站:https://clinicaltrials.gov/ct2/show/NCT04492670,注册表号:NCT04492670),于2020年7月30日注册。
    BACKGROUND: Knee osteoarthritis (KOA) is a common degenerative joint condition that causes disability and pain in the elderly population. The prevalence of KOA among persons aged 63 or above is approximately 30%. Previous studies have reported the positive effects of Tui-na treatment and the Chinese herbal formula Du-Huo-Ji-Sheng Decoction (DHJSD) for KOA treatment. The current study aims to evaluate the add-on therapeutic effect of oral administration of DHJSD on KOA in addition to Tui-na.
    METHODS: We conducted a prospective, randomized, controlled clinical trial. Seventy study subjects with KOA were randomly assigned to the treatment and control groups in a 1:1 ratio. Both two groups received eight sessions of Tui-na manipulation for 4 weeks. The DHJSD was only administered to the study subjects in the treatment group. The primary outcome measure was rated using the WOMAC at the end of treatment (4 weeks). Secondary outcomes were assessed using EQ-5D-5L, a health-related quality of life with 5-level EQ-5D version at end of treatment (week 4) and follow-up (week 8).
    RESULTS: No statistically significant difference was found between two groups on WOMAC scores at the end of treatment. The mean WOMAC Pain subscale score was significantly lower in the treatment group than control group at week 8 follow up (mean difference, MD - 1.8, 95% CI - 3.5 to - 0.02, P = 0.048). The mean WOMAC Stiffness subscale score was significantly lower in the treatment group than in the control group at week 2 (MD 0.74, 95% CI 0.05 to 1.42, P = 0.035) and week 8 follow up (MD 0.95, 95% CI 0.26 to 1.65, P = 0.008). The mean EQ-5D index value was significantly improved in the treatment group than in the control group at week 2 (MD 0.17, 95% CI 0.02 to 0.31, P = 0.022). The analysis of WOMAC scores and EQ-5D-5L in both groups showed statistically significant improvement with time. No significant adverse effect was found during the trial.
    CONCLUSIONS: DHJSD may have an add-on effect in addition to Tui-na manipulation relieving pain and improving stiffness as well as quality of life (QOL) in patients with KOA. The combined treatment was generally safe and well tolerated. Trial registration The study was registered at the ClinicalTrials.gov (website: https://clinicaltrials.gov/ct2/show/NCT04492670 , registry number: NCT04492670), registered on 30 July 2020.
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