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哪些人可能会从丹麦骨关节炎美好生活(GLAD)运动与教育项目中受益?一项随机对照试验的效应修饰分析。

Who are likely to benefit from the Good Life with osteoArthritis in Denmark (GLAD) exercise and education program? An effect modifier analysis of a randomised controlled trial.

作者信息

Henriksen M, Nielsen S M, Christensen R, Kristensen L E, Bliddal H, Bartholdy C, Boesen M, Ellegaard K, Hunter D J, Altman R, Bandak E

机构信息

The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Denmark.

The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.

出版信息

Osteoarthritis Cartilage. 2023 Jan;31(1):106-114. doi: 10.1016/j.joca.2022.09.001. Epub 2022 Sep 8.

Abstract

OBJECTIVE

To identify contextual factors that modify the treatment effect of the 'Good Life with osteoArthritis in Denmark' (GLAD) exercise and education programme compared to open-label placebo (OLP) on knee pain in individuals with knee osteoarthritis (OA).

METHODS

Secondary effect modifier analysis of a randomised controlled trial. 206 participants with symptomatic and radiographic knee OA were randomised to either the 8-week GLAD programme (n = 102) or OLP given as 4 intra-articular saline injections over 8 weeks (n = 104). The primary outcome was change from baseline to week 9 in the Knee injury and Osteoarthritis Outcome Score questionnaire (KOOS) pain subscale (range 0 (worst) to 100 (best)). Subgroups were created based on baseline information: BMI, swollen study knee, bilateral radiographic knee OA, sports participation as a young adult, sex, median age, a priori treatment preference, regular use of analgesics (NSAIDs or paracetamol), radiographic disease severity, and presence of constant or intermittent pain.

RESULTS

Participants who reported use of analgesics at baseline seem to benefit from the GLAD programme over OLP (subgroup contrast: 10.3 KOOS pain points (95% CI 3.0 to 17.6)). Participants with constant pain at baseline also seem to benefit from GLAD over OLP (subgroup contrast: 10.0 points (95% CI 2.8 to 17.2)).

CONCLUSIONS

These results imply that patients who take analgesics or report constant knee pain, GLAD seems to yield clinically relevant benefits on knee pain when compared to OLP. The results support a stratified recommendation of GLAD as management of knee OA.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03843931. EudraCT number 2019-000809-71.

摘要

目的

确定与开放标签安慰剂(OLP)相比,在丹麦骨关节炎“美好生活”(GLAD)运动与教育计划对膝关节骨关节炎(OA)患者膝关节疼痛的治疗效果产生影响的背景因素。

方法

一项随机对照试验的二次效应修饰分析。206名有症状且经影像学检查确诊膝关节OA的参与者被随机分为8周的GLAD计划组(n = 102)或在8周内进行4次关节内注射生理盐水的OLP组(n = 104)。主要结局是从基线到第9周膝关节损伤和骨关节炎结局评分问卷(KOOS)疼痛子量表(范围为0(最差)至100(最佳))的变化。根据基线信息创建亚组:体重指数(BMI)、研究侧膝关节肿胀、双侧影像学膝关节OA、年轻时的运动参与情况、性别、年龄中位数、预先的治疗偏好、镇痛药(非甾体抗炎药或对乙酰氨基酚)的常规使用情况、影像学疾病严重程度以及持续性或间歇性疼痛的存在情况。

结果

在基线时报告使用镇痛药的参与者似乎比OLP组从GLAD计划中获益更多(亚组对比:10.3个KOOS疼痛评分点(95%置信区间3.0至17.6))。基线时有持续性疼痛的参与者似乎也比OLP组从GLAD计划中获益更多(亚组对比:10.0分(95%置信区间2.8至17.2))。

结论

这些结果表明,与OLP相比,服用镇痛药或报告有持续性膝关节疼痛的患者,GLAD似乎在膝关节疼痛方面产生临床相关益处。这些结果支持将GLAD作为膝关节OA管理的分层推荐。

试验注册

ClinicalTrials.gov标识符:NCT03843931。欧盟临床试验注册号2019-000809-71。

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