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: 8319235
• 负责人: G KELLEY FITZGERALD
• 金额: $ 29.34万
• 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/8319235
• 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）患者疼痛和残疾的第一线治疗是有效的，但研究表明其效果随着时间的推移而显著减弱。“助推器”干预会议（监督治疗出院后定期面对面的随访预约，旨在审查和推进患者的家庭计划，解决计划中的问题等）已被建议使有益效果持续下去，但这一建议尚未得到充分的测试。也有迹象表明，手工疗法（MT），手工应用的治疗技术，如关节活动/操纵，手动牵引，软组织操纵和被动拉伸，当与ET相结合时，可以提高康复的整体效果，减轻疼痛和残疾，并且可以显著延迟或减少膝关节OA患者全膝关节置换术的需要，减少药物摄入。然而，目前公布的基于证据的治疗指南表明，没有足够的数据来提出关于在康复计划中使用MT和ET的明确建议。因此，该项目的总体目标是检查在提供ET的过程中利用加强会议的临床和成本效益，并用MT技术补充ET。该研究将是一项多中心、多国随机临床试验，采用2 × 2因子设计（因子1 =增强剂vs.无增强剂，因子2 =单独ET vs. ET + MT）。300名患有膝关节炎的受试者（每个研究地点75名）将被随机分为以下组：1)ET -无增强剂，2)ET -有增强剂，3)MT + ET -无增强剂，4)MT + ET -有增强剂。临床结果测量（WOMAC、膝关节疼痛、总体变化评分和基于性能的功能测量）将在基线（随机化之前）、初始治疗阶段（9周）完成时和1年随访时进行。临床结果的主要终点将是1年的WOMAC。对于成本效益分析，从社会角度来看，主要成本结果将是骨关节炎治疗成本，包括实施每种干预措施的卫生系统成本、医疗/手术成本（初级、二级和三级护理成本）和参与者的个人成本（旅行、非资助药物、休息时间和生活质量负担）。主要的有效性结果测量将是质量调整生命年（QALYs），使用生活质量效用从SF-12分数中获得，并使用适当的原产国偏好权重。干预措施之间的成本和效果值将通过增量成本-效果比进行比较，当选择给定的干预措施时，产生每个QALY的增量成本。二级分析将从卫生系统和患者的角度检查成本效益。成本和效果数据将在1年和2年随访时获得。2年的随访将是成本-效果分析的主要终点。