Bracing the Patellofemoral Osteoarthritis: A Clinical Trial

支撑髌股骨关节炎：临床试验

• 批准号: 8131780
• 负责人: David John Hunter
• 金额: $ 5.99万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8131780
• 关键词: Academic Medical Centers; Adhesives; Adopted; Age; Boston; Braces-Orthopedic appliances; Clinical Trials; Communities; Cross-Over Studies; Degenerative polyarthritis; Disease; Double-Blind Method; Elderly; Epidemiologic Studies; Evaluation Studies; Excision; Follow-Up Studies; Future; Heterogeneity; Individual; Intervention; Joints; Knee; Knee Osteoarthritis; Knee bone; Longitudinal Studies; Lower Extremity; Modality; Movement; Outcome; Pain; Participant; Patients; Persons; Placebos; Population; Prevalence; Process; Public Health; Randomized; Recruitment Activity; Research; Running; Source; Suggestion; Symptoms; Testing; Therapeutic; Therapeutic Intervention; Time; Use Effectiveness; aged; design; disability; drug development; effective intervention; follow-up; improved functioning; knee pain; open label; physical neglect; primary outcome; skin irritation

Osteoarthritis (OA) is a significant public health challenge, being ranked as the leading cause of disability in elders. Relatively little heed has been paid to studying or treating the patellofemoral (PF) joint in OA, despite suggestions that disease there may be strongly correlated with lower extremity disability. The specific aims of this proposal are: 1) To undertake a 20 week randomized crossover clinical trial in patients with patellofemoral osteoarthritis to determine whether provision of patellofemoral bracing leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment; 2) To perform an open label follow-up study to track use and effectiveness of treatment. We propose a double blind, randomized crossover trial of a patellofemoral bracing for patients with patellofemoral osteoarthritis with the primary outcome being knee pain as assessed by the VAS scale on movement, and pain during an aggravating activity nominated by the participant. The two treatments will be as follows: TREATMENT A (CONTROL), a neutral brace without the donut (buttress) and realigning strap and TREATMENT B (ACTIVE), a patellofemoral brace (DonJoy Tru-pull advanced). A run-in design will be used to maximize the likelihood of recruiting subjects who will remain in the trial. Subjects will be randomized to treatment A or B for 6 weeks, with an 8 week washout. For each subject, the trial will last 20 weeks. Study evaluation will take place at the Boston University Medical Center GCRC. The subject's will then be followed for 6 months in an open-label follow-up. Recent estimates suggest that symptomatic knee OA occurs in 13% of persons age 60 and over. There has been a remarkable neglect of physical treatment modalities that is, in part, a consequence of drug development opportunities. The need to develop treatment approaches that are capable of ameliorating the symptoms of OA is an important research objective. This project constitutes an attempt to test a promising physical treatment modality. The short-term outcomes of this project will be to assess the efficacy of knee bracing for pain and disability in patellofemoral osteoarthritis. The longer-term outcome of demonstrating efficacy of such an intervention will be to reduce pain and disability arising from patellofemoral osteoarthritis in the wider community.

骨关节炎（OA）是一个重大的公共卫生挑战，被列为残疾的主要原因 在老年人。相对较少注意研究或治疗OA中的髌股（PF）关节， 尽管有人认为这种疾病可能与下肢残疾密切相关。 这项建议的具体目标是： 1)在髌股关节置换患者中进行一项为期20周的随机交叉临床试验， 骨关节炎，以确定提供髌股支具是否会降低疼痛评分， 与使用安慰剂治疗期间相比，治疗期间功能改善; 2)进行开放标签随访研究，以跟踪治疗的使用和有效性。 我们提出了一个双盲，随机交叉试验的髌股支具的患者， 髌股骨关节炎，主要结局为膝关节疼痛，通过VAS量表评估， 运动和疼痛在加重活动期间由参与者指定。这两种治疗方法将 如下：治疗A（对照组），无圆环（支撑物）和重新定位带的中性支具 治疗B（ACTIVE），髌股支具（DonJoy Tru-pull advanced）。 将使用导入设计，以最大限度地招募将留在试验中的受试者。 受试者将随机分配至治疗A或B，持续6周，洗脱期为8周。对于每个主题， 审判将持续20周。研究评价将在波士顿大学医学中心GCRC进行。的 然后在开放标签随访中对受试者进行6个月的随访。 最近的估计表明，有症状的膝关节OA发生在13%的60岁及以上的人。一直 一直是一个显着忽视物理治疗方式，这是，部分，药物的后果， 发展机遇。需要开发能够改善这些疾病的治疗方法， OA的症状是一个重要的研究目标。这个项目是一个尝试，以测试一个有前途的 物理治疗模式。本项目的短期结果将是评估膝关节置换术的疗效。 髌股骨关节炎疼痛和残疾的支撑。长期来看， 这种干预的有效性将是减少由髌股骨关节炎引起的疼痛和残疾 在更广泛的社区。