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评估一种新型智能手机应用程序与标准随访相比,对接受海兰G-F 20治疗的膝骨关节炎患者活动能力的影响:一项随机对照试验。

Assessing the Impact of a Novel Smartphone Application Compared With Standard Follow-Up on Mobility of Patients With Knee Osteoarthritis Following Treatment With Hylan G-F 20: A Randomized Controlled Trial.

作者信息

Skrepnik Nebojsa, Spitzer Andrew, Altman Roy, Hoekstra John, Stewart John, Toselli Richard

机构信息

Tucson Orthopaedic Institute, Tucson, AZ, United States.

Cedar-Sinai Orthopaedic Center, Los Angeles, CA, United States.

出版信息

JMIR Mhealth Uhealth. 2017 May 9;5(5):e64. doi: 10.2196/mhealth.7179.

Abstract

BACKGROUND

Osteoarthritis (OA) is a leading cause of disability in the United States. Although no disease-modifying therapies exist, patients with knee OA who increase walking may reduce risk of functional limitations.

OBJECTIVE

The objective of the study is to evaluate the impact of a mobile app (OA GO) plus wearable activity monitor/pedometer (Jawbone UP 24) used for 90 days on the mobility of patients with knee OA treated with hylan G-F 20.

METHODS

Patients with knee OA aged 30 to 80 years who were eligible to receive hylan G-F 20 and were familiar with smartphone technology were enrolled in this randomized, multicenter, open-label study. Patients who had a body mass index above 35 kg/m were excluded. All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (Group A; n=107) with visible feedback (unblinded) or Jawbone only (Group B; n=104) with no visible feedback (blinded). The primary endpoint was mean change from baseline in steps per day at day 90 between Groups A and B.

RESULTS

Baseline characteristics were similar between groups. There were significant differences between the increases in least squares (LS) mean number of steps per day (1199 vs 467, P=.03) and the mean percentage change (35.8% vs 11.5%, P=.02) from baseline in favor of Group A over Group B. There was a greater reduction in pain from baseline during the 6-minute walk test in Group A versus Group B. (LS mean change: -55.3 vs -33.8, P=.007). Most patients (65.4%) and surveys of physicians (67.3%) reported they would be likely or very likely to use/recommend the devices. Patient Activity Measure-13 scores improved from baseline (LS mean change for Groups A and B: 5.0 vs 6.9), with no significant differences between groups. The occurrence of adverse events was similar in the 2 groups.

CONCLUSIONS

Use of a novel smartphone app in conjunction with a wearable activity monitor provided additional improvement on mobility parameters such as steps per day and pain with walking in the 6-minute walk test in patients with knee OA who were treated with hylan G-F 20. Results also highlight the amenability of patients and physicians to using mobile health technology in the treatment of OA and suggest further study is warranted.

摘要

背景

骨关节炎(OA)是美国导致残疾的主要原因。尽管尚无改善病情的疗法,但膝骨关节炎患者增加步行量可能会降低功能受限的风险。

目的

本研究的目的是评估一款移动应用程序(OA GO)加可穿戴活动监测器/计步器(卓棒UP 24)使用90天对接受透明质酸钠G-F 20治疗的膝骨关节炎患者活动能力的影响。

方法

年龄在30至80岁、符合接受透明质酸钠G-F 20治疗条件且熟悉智能手机技术的膝骨关节炎患者被纳入这项随机、多中心、开放标签研究。排除体重指数高于35 kg/m的患者。所有患者均接受一次6毫升透明质酸钠G-F 20注射并佩戴卓棒监测器。然后患者按1:1随机分为卓棒和OA GO组(A组;n = 107),有可见反馈(不设盲)或仅卓棒组(B组;n = 104),无可见反馈(设盲)。主要终点是A组和B组在第90天时每天步数较基线的平均变化。

结果

两组的基线特征相似。A组每天步数的最小二乘(LS)均值增加量(1199步对467步,P = 0.03)以及较基线的平均百分比变化(35.8%对11.5%,P = 0.02)均显著高于B组。与B组相比,A组在6分钟步行试验期间疼痛较基线的减轻程度更大。(LS均值变化:-55.3对-33.8,P = 0.007)。大多数患者(65.4%)和医生调查(67.3%)报告他们很可能或非常可能使用/推荐这些设备。患者活动量测量-13评分较基线有所改善(A组和B组的LS均值变化:5.0对6.9),两组间无显著差异。两组不良事件的发生率相似。

结论

对于接受透明质酸钠G-F 20治疗的膝骨关节炎患者,使用一款新型智能手机应用程序结合可穿戴活动监测器在诸如每天步数和6分钟步行试验中的步行疼痛等活动参数方面提供了额外改善。结果还突出了患者和医生对在骨关节炎治疗中使用移动健康技术的接受度,并表明有必要进行进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e419/5442351/82d3c6cec1a1/mhealth_v5i5e64_fig1.jpg

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