ACUPUNCTURE FOR DENTAL PAIN--TESTING A MODEL

针灸治疗牙痛——模型测试

• 批准号: 2805191
• 负责人: LIXING LAO
• 金额: $ 39.48万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2805191
• 关键词: acupuncture /acupressure; alternative medicine; analgesia; clinical research; clinical trials; human subject; human therapy evaluation; postoperative state; tooth extraction

Third molar extraction and other dental surgeries commonly produce pain, swelling, and transient functional disability. Analgesic medications, used to treat postoperative pain, often produce local or systemic side effects. Acupuncture for pain control may offer an effective adjunctive treatment to medication. However, rigorous scientific research to evaluate the efficacy and safety of acupuncture is needed. The aims of this study are: 1) to develop and test two minimal sham acupuncture control procedures; 2) to compare the analgesic effects of real acupuncture to a) minimal sham acupuncture and b) inert placebo acupuncture; 3) to evaluate patient blinding; 4) to determine whether patients' attitudes are associated with outcomes; and 5) to assess acupuncture safety. The proposed two-phase study includes double-blind, randomized controlled trial methods. This study will test the hypothesis that acupuncture can produce better analgesic effects than control on postoperative dental pain using a partially impacted third molar extraction model. The first phase (pilot study, n=40 per group) will develop and validate two sham procedures to test the efficacy of acupuncture. The second phase (sample size to be determined by first phase data) will test the efficacy and safety of real acupuncture compared to the sham model developed in phase I and a placebo model. Both phases will utilize a standardized pain assessment instrument to measure pain intensity and pain free time at six hours postoperatively through a seven-day follow-up period.

拔除第三磨牙和其他牙科手术通常会产生疼痛， 肿胀和一过性功能障碍。止痛药， 用于治疗术后疼痛，常产生局部或全身副作用 效果。针灸止痛可能提供一种有效的辅助手段 从治疗到药物治疗。然而，严谨的科学研究 需要对针灸的疗效和安全性进行评估。 本研究的目的是：1)开发和测试两个最小伪装 针刺控制程序；2)比较针刺对小鼠的镇痛作用 真正的针灸到a)最小的假针灸和b)惰性安慰剂 针灸；3)评估患者致盲；4)确定 患者的态度与结果有关；以及5)评估 针灸安全。 拟议的两阶段研究包括双盲、随机 对照试验方法。这项研究将检验这一假设 针刺能比对照组产生更好的止痛效果 部分阻生第三磨牙术后牙痛的研究 提取模型。第一阶段(试验性研究，每组40人)将 开发并验证两个假程序以测试 针灸。第二阶段(样本大小由第一阶段决定 阶段数据)将测试真正的针灸的有效性和安全性 与第一阶段开发的假模型和安慰剂模型进行比较。 这两个阶段都将利用标准化的疼痛评估工具来 术后6小时测量疼痛强度和无痛时间 通过七天的随访期。