Enhancing the Effectiveness of Physical Therapy in People with Knee OA

提高膝关节骨关节炎患者物理治疗的效果

• 批准号: 8136320
• 负责人: G KELLEY FITZGERALD
• 金额: $ 44.8万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136320
• 关键词: Enhancing; Effectiveness; Physical; Therapy; People

DESCRIPTION (provided by applicant): Exercise therapy (ET) is effective as the first line of treatment for reducing pain and disability in patients with knee osteoarthritis (OA), but studies show its effects diminish considerably over time. 'Booster' intervention sessions (periodic face-to-face follow-up appointments following discharge from supervised therapy designed to review and progress the patient's home program, troubleshoot problems with the program, etc.) have been recommended to make beneficial effects endure however this recommendation has not been adequately tested. There are also indications that manual therapy (MT), manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, and passive stretching, when combined with ET, may improve the overall effectiveness of rehabilitation for reducing pain and disability, and, may significantly delay or reduce the need for total knee arthroplastic surgery and reduce medication intake in people with knee OA. However, current published evidence-based treatment guidelines indicate there is not enough data to make a definitive recommendation regarding the use of MT with ET in rehabilitation programs. Therefore, the overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions in the delivery of ET, and supplementing ET with MT techniques. The study will be a multi-center, multi-national randomized clinical trial, using a 2 x 2 factorial design (factor 1 = booster vs. no booster, factor 2 = ET alone vs. ET + MT). Three hundred subjects (75 per study site) with knee OA will be randomized to one of the following groups: 1) ET - no booster, 2) ET - with booster, 3) MT + ET - no booster sessions, 4) MT + ET - with booster sessions. Clinical outcome measures (WOMAC, knee pain, global rating of change and performance-based measures of function) will be taken at baseline (prior to randomization), at the completion of the initial therapy sessions (9 weeks) and at 1 year follow-up. The primary endpoint for clinical outcome will be the WOMAC at 1 year. For the cost effectiveness analysis, the primary cost outcome will be osteoarthritis treatment costs from the societal perspective, which will include health system costs for implementing each intervention, medical/surgical costs (primary, secondary, and tertiary care costs), and personal costs to participants (travel, non-funded medications, time off work, and quality-of-life burdens). The primary effectiveness outcome measure will be quality-adjusted life-years (QALYs), derived using quality of life utilities from SF-12 scores using appropriate preference weightings for the country of origin. Cost and effectiveness values between interventions will be compared via incremental cost-effectiveness ratios, yielding incremental costs per QALY gained when a given intervention is chosen. Secondary analyses will examine cost-effectiveness from health system and from patient perspectives. Cost and effectiveness data will be obtained at 1 year and 2 year follow-ups. The 2 year follow-up will be the primary endpoint for the cost-effectiveness analysis. PUBLIC HEALTH RELEVANCE: Combining booster sessions and manual therapy techniques with exercise therapy may improve the overall effectiveness of rehabilitation over the current state of practice and may also ensure long term maintenance of the beneficial effects. The study interventions could lead to prevention or delay in disability, reduce or delay the need for total knee replacement surgery, and reduce medication intake. These beneficial effects could have a profound impact on reducing the cost of care to society and to the person with knee OA, a major cause of disability and health care cost in the United States.

描述（由申请人提供）：运动疗法（ET）作为减轻膝关节骨关节炎（OA）患者疼痛和残疾的一线治疗是有效的，但研究表明其效果随着时间的推移而大大减弱。“助推器”干预会议（在从监督治疗出院后定期进行面对面的随访，旨在审查和推进患者的家庭计划，解决计划问题等）已建议使有益效果持久，但这一建议尚未得到充分的检验。也有迹象表明，手动治疗（MT），手动应用的治疗技术，如关节松动/操作，手动牵引，软组织操作和被动拉伸，当与ET结合时，可以提高康复的整体有效性，以减少疼痛和残疾，并可能显着延迟或减少全膝关节成形术的需要，并减少膝关节OA患者的药物摄入。然而，目前已发表的循证治疗指南表明，没有足够的数据对MT与ET在康复计划中的使用提出明确的建议。因此，该项目的总体目标是研究在ET的交付中利用助推器会议的临床和成本效益，以及用MT技术补充ET。本研究将是一项多中心、多国随机临床试验，采用2 × 2析因设计（因子1 =加强vs.无加强，因子2 = ET单药vs. ET + MT）。将300例膝关节OA受试者（每个研究中心75例）随机分配至以下组之一：1）ET -无加强治疗，2）ET -有加强治疗，3）MT + ET -无加强治疗，4）MT + ET -有加强治疗。将在基线（随机化前）、完成初始治疗（9周）和1年随访时进行临床结局指标（WOMAC、膝关节疼痛、总体变化评级和基于性能的功能指标）。临床结局的主要终点为1年时的WOMAC。对于成本效益分析，主要成本结果将是从社会角度来看的骨关节炎治疗成本，其中包括实施每项干预措施的卫生系统成本、医疗/手术成本（一级、二级和三级护理成本）以及参与者的个人成本（旅行、非资助药物、休假时间和生活质量负担）。主要有效性结局指标将是质量调整生命年（QOL），使用SF-12评分的生活质量效用（使用适当的原籍国偏好权重）得出。将通过增量成本-效果比比较干预措施之间的成本和效果值，得出选择特定干预措施时获得的每QALY增量成本。二次分析将从卫生系统和患者的角度审查成本效益。将在1年和2年随访时获得成本和有效性数据。2年随访将是成本-效果分析的主要终点。 公共卫生关系：结合助推器会议和手动治疗技术与运动疗法可以提高康复的整体效果，在目前的实践状态，也可以确保长期维持的有益效果。研究干预措施可能会预防或延迟残疾，减少或延迟全膝关节置换手术的需求，并减少药物摄入。这些有益的影响可能对降低社会和膝关节OA患者的护理成本产生深远的影响，膝关节OA是美国残疾和医疗保健成本的主要原因。