An RCT for Treating Carpometacarpal Osteoarthritis

治疗腕掌骨关节炎的随机对照试验

• 批准号: 6718729
• 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/6718729
• 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）： 腕掌骨关节炎 (CMC CA) 是老年女性中非常常见的问题；大约 75% 的绝经后妇女有一些关节破坏的证据，其中至少三分之一有症状。男性也会受到影响，但较少见。 CMC CA 会导致疼痛、畸形、不稳定并最终丧失手部功能。虽然手术对于严重疾病有效，但对于中度疼痛和残疾的药物治疗数量有限。对于对非甾体抗炎药或关节固定没有反应的患者，关节内皮质类固醇是主要治疗手段。然而，尚无评估这种疗法的随机、安慰剂对照试验。目前尚不清楚什么可以预测皮质类固醇的反应，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，另一种关节内疗法透明质酸（HA）被引入治疗膝骨关节炎。尽管 HA 疗法正在获得广泛应用，但由于研究设计的缺陷和有争议的数据解释，其治疗膝关节 CA 的疗效仍存在争议。也有HA用于治疗颞下颌关节和骶髂关节CA的病例报告，随着时间的推移，HA可能会得到更广泛的应用。然而，HA 是一种昂贵的疗法，只有在具有明显的治疗效果时才应使用。我们提出了一项随机、安慰剂对照试验来比较 CMC CA 患者的关节内皮质类固醇、关节内 HA 和安慰剂注射。我们希望通过一项严格的、精心设计的试验，利用意向治疗分析计划，避免围绕 HA 在膝关节中使用的一些疗效争议。通过这项试验，我们还希望确定皮质类固醇在 CMC CA 中的疗效。这将填补文献空白，并为关节内皮质类固醇提供循证数据，目前其使用仅基于轶事和传统实践。