Stepped care approach for medial tibiofemoral osteoarthritis (STrEAMline): protocol for a randomised controlled trial.
Stepped care approach for medial tibiofemoral osteoarthritis (STrEAMline): protocol for a randomised controlled trial.
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DOI：
10.1136/bmjopen-2017-018495
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发表时间：
2017-12-26
期刊：
影响因子：
2.9
通讯作者：
Hunter DJ
中科院分区：
文献类型：
--
作者：
Robbins SR;Melo LRS;Urban H;Deveza LA;Asher R;Johnson VL;Hunter DJ
目前的指南建议采取量身定制的干预措施，以优化膝骨性关节炎(OA)的治疗。然而，护理模式仍然有一种“一刀切”的方法，这是次优的，因为它忽略了患者的异质性。本研究旨在对患有胫股内侧骨关节炎的超重和肥胖者的分级护理策略和标准护理进行比较。参与者将被随机分为两组(每组85人)。在研究的第一步，干预将接受为期18周的饮食和锻炼计划。然后使用患者可接受症状状态(PASS)评估疾病缓解情况。PASS被定义为患者认为自己良好的最高症状级别，并考虑了疼痛强度、患者对疾病活动的总体评估和功能损害程度。在第二步，缓解期的参与者将继续进行饮食和锻炼。如果没有缓解，参与者将按等级顺序被分配到认知行为治疗、膝关节支撑或肌肉强化12周。干预措施将根据他们抑郁和内翻畸形的临床表现来决定。没有抑郁或内翻畸形的参与者将进行肌肉强化计划。对照组将收到与办公自动化管理相关的教育材料。主要入选标准为：年龄≥50岁，X线片胫股内侧骨关节炎，体重指数≥28 kg/m2，膝关节疼痛≥40(视觉模拟评分，0-100)，疼痛和整体评估PASS(0-100)>；32，功能障碍31。结果将在20周和32周的访问中进行衡量。主要结果是在32周时疾病缓解。其他结果包括功能活动能力；患者报告的结果；BMI；腰臀比；股四头肌力量；抑郁、焦虑和压力的症状；以及膝关节的活动范围。分析将按照意向治疗原则进行。地方伦理委员会批准了该议定书(HREC/14/Hawke/381)。将通过在国际会议上发表演讲和在同行评议的期刊上发表文章来进行传播。ACTRN12615000227594。
Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a ‘one size fits all’ approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA. Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient’s global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ≥50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ≥28 kg/m2, knee pain ≥40 (Visual Analogue Scale, 0–100), PASS (0–100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle. The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals. ACTRN12615000227594.
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影响因子：
4.2
作者：
Bastick AN;Belo JN;Runhaar J;Bierma-Zeinstra SM
通讯作者：
Bierma-Zeinstra SM
影响因子：
4.9
作者：
Bastick, Alex N.;Runhaar, Jos;Bierma-Zeinstra, Sita M. A.
通讯作者：
Bierma-Zeinstra, Sita M. A.
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通讯作者：
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作者：
Kraus, VB;Vail, TP;McDaniel, G
通讯作者：
McDaniel, G