TCM for TMD: A Multi-Site Whole Systems Trial

描述(由申请人提供)：颞颌关节功能障碍(TMD)是一种慢性疼痛状况，影响到相当一部分美国人口，但通常不在医疗计划的覆盖范围内。尽管进行了几次TMD临床试验，但还没有发现一种方法可以持续显著地减少这种情况下的疼痛和残疾。我们最近的II期随机对照试验(n=110名妇女)显示，在提供短期连续疗程的情况下，整个系统的中医结合针灸和草药，在减轻TMD疼痛方面与综合专科护理相当或更好，在改善残疾方面更好。然而，一旦中医治疗结束，这种改善并没有持续下去。 该提案测试了整个系统中医与自我护理管理(SC)在综合、分级护理策略中的对比，该策略从最低限度的干预开始，并根据患者的需求增加强度。这种设计比传统的不考虑患者预后的两组随机对照试验更有临床意义。我们建议进行一项多地点(图森和波特兰)的II期试验，扩大患者群体，包括男性和女性，以及那些以前接受过TMD常规治疗(而不是中医)并继续患有TMD疼痛的人。所有患者(n=150)都将接受自我护理策略的指导。在预定的评估点，没有接受中医治疗的参与者将被随机分为自我护理高级阶段或中医阶段。我们将评估中医药的短期疼痛和残疾效果，并在18个月的随访中，将长期中医药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，并由图森亚洲医学研究所领导指导图森的中医护理。这项建议测试了一种适合于各种医疗保健提供者的分级护理策略，并评估了一种忠于对抗疗法和替代医学的完整系统研究方法。

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.