TCM for TMD: A Multi-Site Whole Systems Trial

描述（由申请人提供）：颞下颌关节功能障碍（TMD）是一种慢性疼痛状况，影响了相当一部分美国人口，但通常不包括在健康计划中。尽管进行了几次TMD临床试验，但没有发现一种方法可以持续显著地减少这种疾病的疼痛和残疾。我们最近的II期随机对照试验（n=110名女性）显示，在短期连续治疗过程中，针灸和草药的全系统中医（TCM）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。

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.