TCM for TMD: A Multi-Site Whole Systems Trial

TCM for TMD：多站点整体系统试验

• 批准号: 7099413
• 负责人: CHERYL KAY RITENBAUGH
• 金额: $ 60.38万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7099413
• 关键词: Chinese; acupuncture /acupressure; alternative medicine; analgesia; chronic pain; clinical research; clinical trial phase II; cooperative study; data collection methodology /evaluation; folk medicine; health care service utilization; human subject; human therapy evaluation; interview; longitudinal human study; outcomes research; patient care management; patient oriented research; quality of life; questionnaires; self care; statistics /biometry; temporomandibular joint syndrome; therapy compliance

DESCRIPTION (provided by applicant): Temporomandibular joint dysfunction (TMD) is a chronic pain condition that affects a substantial fraction of the US population but is frequently not covered by health plans. In spite of several TMD clinical trials, no approach has been found to consistently and significantly reduce the pain and disability of this condition. Our recent phase II RCT (n=110 women) showed that whole system Traditional Chinese Medicine (TCM), with acupuncture and herbs, was comparable to or better than comprehensive specialty care in reducing TMD pain, and better in improving disability, when provided in a short-term continuous course of treatment. The improvements did not persist, however, once TCM treatment ended. The proposal tests whole system TCM versus self-care management (SC) in an integrative, stepped care strategy that begins with a minimal intervention and increases the intensity in relation to patient needs. This design is more clinically meaningful than a customary two-group RCT which does not consider patient outcomes. We propose a multi-site (Tucson and Portland) phase II trial that will expand the patient population to include both men and women and those who previously received TMD usual care (not TCM) and continue to have TMD pain. All patients (n=150) will receive instruction in self-care strategies. At predetermined assessment points, participants not on TCM will be randomized either to advanced steps of self care or to TCM. We will evaluate the short-term pain and disability effects of TCM, and in follow up to18 months, compare long-term TCM to self-care management. The University of Arizona (Tucson) and the Oregon College of Oriental Medicine (OCOM, Portland) will manage assessment and self-care. OCOM will provide the TCM care in Portland and guide the TCM care in Tucson led by the Tucson Asian Medical Institute. This proposal tests a stepped care strategy appropriate to a variety of health care providers, and evaluates a whole systems research approach faithful to both allopathic and alternative medicine.

描述（由申请人提供）：颞下颌关节功能障碍 (TMD) 是一种慢性疼痛疾病，影响着很大一部分美国人口，但通常不属于健康计划的承保范围。尽管进行了多项 TMD 临床试验，但尚未发现能够持续且显着减轻这种疾病的疼痛和残疾的方法。我们最近的 II 期随机对照试验（n = 110 名女性）表明，在减少 TMD 疼痛和改善残疾方面，包括针灸和草药在内的全系统中医 (TCM) 在减轻 TMD 疼痛方面与综合专业护理相当或更好，并且在改善残疾方面效果更好。短期连续疗程。然而，中医治疗结束后，这种改善并没有持续下去。 该提案以综合、阶梯式护理策略测试整个系统的中医与自我护理管理（SC），该策略从最小的干预开始，并根据患者需求增加强度。该设计比不考虑患者结果的常规两组随机对照试验更具临床意义。我们提议进行一项多中心（图森和波特兰）II 期试验，该试验将扩大患者群体，包括男性和女性以及之前接受过 TMD 常规护理（而非 TCM）并继续患有 TMD 疼痛的患者。所有患者 (n=150) 将接受自我护理策略指导。在预定的评估点，未接受中医治疗的参与者将被随机分配到高级自我护理步骤或中医治疗。我们将评估中医对短期疼痛和残疾的影响，并在长达 18 个月的随访中，将长期中医与自我护理管理进行比较。亚利桑那大学（图森）和俄勒冈东方医学院（OCOM，波特兰）将管理评估和自我护理。 OCOM 将在波特兰提供中医护理，并指导由图森亚洲医​​学研究所领导的图森的中医护理。该提案测试了适合各种医疗保健提供者的阶梯式护理策略，并评估了忠实于对抗疗法和替代医学的整个系统研究方法。