TCM for TMD: A Multi-Site Whole Systems Trial

TCM for TMD：多站点整体系统试验

• 批准号: 6979918
• 负责人: CHERYL KAY RITENBAUGH
• 金额: $ 53.46万
• 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/6979918
• 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，影响相当一部分美国人口，但通常不包括在健康计划中。尽管有几个TMD的临床试验，没有办法已经发现，以一贯和显着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）表明，整个系统的中医药（TCM），针灸和草药，是可比的或优于综合专科护理，在减少TMD疼痛，更好地改善残疾，在短期的连续治疗过程中提供。然而，一旦中医治疗结束，这些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）在一个综合的，分步的护理策略，从最小的干预开始，并根据患者的需求增加强度。这种设计比不考虑患者结局的常规两组RCT更具临床意义。我们建议进行一项多中心（图森和波特兰）II期试验，将患者人群扩大到包括男性和女性以及那些以前接受TMD常规治疗（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TCM治疗的受试者将被随机分配到高级自我护理步骤或TCM。我们将评估中医的短期疼痛和残疾的影响，并在随访18个月，比较长期中医自我护理管理。亚利桑那大学（图森）和俄勒冈州东方医学院（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，并指导图森亚洲医学研究所领导的图森中医护理。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。