An RCT for Treating Carpometacarpal Osteoarthritis

治疗腕掌骨关节炎的随机对照试验

• 批准号: 6899260
• 负责人: LISA Ann MANDL
• 金额: $ 10.8万
• 依托单位: HOSPITAL FOR SPECIAL SURGERY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6899260
• 关键词: antiarthritic agent; arthritis therapy; articular cartilage; carpal tunnel syndrome; clinical research; clinical trials; corticosteroids; human subject; human therapy evaluation; hyaluronate; injection /infusion; joint stiffness; osteoarthritis; pain; patient oriented research; radiography; skeletal disorder chemotherapy; skeletal pharmacology

DESCRIPTION (provided by applicant): Carpometacarpal osteoarthritis (CMC CA) is a very common problem among older women; approximately 75% of post-menopausal women have some evidence of joint destruction, with at least one third being symptomatic. Men are also affected, but less commonly. CMC CA leads to pain, deformity, instability and eventually loss of hand function. While surgery is effective for severe disease, there are a limited number of medical treatments for moderate pain and disability. Intra-articular corticosteroids are the mainstay for patients who have not responded to non-steroidal antiinflammatories or joint immobilization. However, there are no randomized, placebo-controlled trials evaluating this therapy. It is unknown what predicts response to corticosteroids, how long any benefit lasts, or if corticosteroids are any better than placebo injection. Recently, another intra-articular therapy, hyaluronan, (HA) has been introduced for osteoarthritis of the knee. Although HA therapy is gaining widespread use, its efficacy in treating knee CA is controversial due to weaknesses in study design and debatable data interpretation. There are also case reports of HA being used to treat CA of the temporomandibular and sacro-iliac joints, and HA will likely achieve more widespread use over time. However, HA is an expensive therapy, and should only be used if it has a demonstrable treatment benefit. We propose a randomized, placebo-controlled trial to compare intra-articular corticosteroids, intra-articular HA, and placebo injections in patients with CMC CA. We hope to avoid some of the efficacy controversies that have surrounded HA use in the knee with a rigorous, well-designed trial utilizing an intention-to-treat analysis plan. Through this trial we also hope to establish the efficacy of corticosteroids in CMC CA. This will fill a gap in the literature, and provide evidence-based data for intra-articular corticosteroids, the present use of which is based only on anecdotal and conventional practices.

描述（由申请人提供）： 在老年妇女中，腕足骨骨关节炎（CMC CA）是一个非常普遍的问题。大约75％的绝经后妇女有一些联合破坏的证据，至少有三分之一是有症状的。男人也受到影响，但不太常见。 CMC CA导致疼痛，畸形，不稳定性和最终的手部功能丧失。虽然手术对严重疾病有效，但对于中度疼痛和残疾的药物治疗数量有限。关节内皮质类固醇是未对非甾体类抗炎或关节固定的患者的中流tay柱。但是，没有评估这种疗法的随机，安慰剂对照试验。尚不清楚是什么预测对皮质类固醇的反应，任何益处持续多长时间，或者皮质类固醇是否比安慰剂注射更好。最近，引入了另一种关节疗法，透明质酸（HA），用于膝盖的骨关节炎。尽管HA疗法正在广泛使用，但由于研究设计中的弱点和有争议的数据解释，其治疗膝盖CA的功效是有争议的。还有一些案例报告说HA被用于治疗颞下颌和sacro-iliac关节的CA，并且随着时间的流逝，HA可能会获得更广泛的使用。但是，HA是一种昂贵的疗法，只有在具有可证明的治疗益处的情况下才能使用。我们提出了一项随机的安慰剂对照试验，以比较CMC患者的关节内皮质类固醇，关节内HA和安慰剂注射。我们希望避免使用意图对治疗分析计划进行严格，精心设计的试验，以围绕HA在膝盖中使用的一些疗效争议。通过这项试验，我们还希望确定在CMC CA中皮质类固醇的功效。这将填补文献中的空白，并为关节内皮质类固醇提供基于证据的数据，目前的用途仅基于轶事和常规实践。