FOUR TREATMENT STRATEGIES FOR TMJ DISK DISPLACEMENT

颞下颌关节盘移位的四种治疗策略

• 批准号: 6134184
• 负责人: ERIC L SCHIFFMAN
• 金额: $ 12.61万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-15 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6134184
• 关键词: clinical research; functional ability; human subject; human therapy evaluation; jaw; longitudinal human study; musculoskeletal disorder therapy; pain; questionnaires; temporomandibular joint syndrome

Treatment for Temporomandibular Disorders (TMD) varies between nonsurgical and surgical interventions. Follow-up studies have shown positive outcomes with either type of intervention. However, due to lack of appropriately designed randomized clinical trials (RCTs), the relative effectiveness of these treatment strategies is not known. This study is the first RCT with an adequate sample size to assess the relative short-term effectiveness of current treatment strategies for subjects with a symptomatic, advanced temporomandibular joint (TMJ) disorder: TMJ disk displacement without reduction with limited mouth opening. This proposal is to continue long-term follow-up of subjects, in this RCT, to evaluate treatment outcomes associated with four treatment strategies for this disorder. These treatment strategies are: Medical Management (Group I), Nonsurgical Rehabilitation (Group II), Arthroscopic Surgery (Group III) and Disk Plication/Repair Surgery (Group IV). Recruitment of subjects is done. Ninety -six subjects have accepted and finished their treatment group assignment. Currently, follow-up exams and questionnaires have been completed at 3, 6, 9, 12, 18, 24, 36, 48 and 60-months post-treatment by 93, 90, 87, 94, 85, 81, 73, 57, and 49 subjects seen currently at each follow-up interval, respectively. The current lost-to-follow-up rate is approximately 15% at 5 years. All subjects will have been in the study at least 2 years at the beginning of this study's proposed funding period. The specific aims of the proposed study is to compare the four treatment strategies according to: 1) an objective measure of jaw function, the Craniomandibular Index (CMI), long-term, at 5 and 10 years, and 2) the subjective perception of pain in the TMJ, measured by applying the Symptom Severity Index to TMJ pain (SSI-JT), long-term, at 3, 4, 5, 6, 7, 8, 9 and 10 years. The primary analyses will compare each of Groups II, III and IV to Group I, to see whether patient outcomes are improved when the initial treatment strategy is more intensive than Group I, that is, medical management. This primary short-term analyses, comparing the CMI and SSI-JT values at 3, 6, 9, 12, 18 and 24 months with patients grouped according to their initial treatment assignment, have found that the other 3 treatment strategies do not improve the outcome, either objectively or subjectively, compared to medical management. Furthermore, relative to the 5 year follow-ups, the conditional power analyses, on the available data for the primary outcome measures, predicts that there is little chance of finding a statistically significant difference between groups at this interval. However, we hold that the 5 years results are not adequate for assessing the lifetime effects of these treatments. Therefore, there is a need to finish long-term follow-up on all currently enrolled subjects to at least 10 years to be able to make definitive conclusions.

颞下颌疾病（TMD）的治疗方法在非手术和手术干预之间有所不同。后续研究显示，两种干预方式均有积极效果。然而，由于缺乏适当设计的随机临床试验（rct），这些治疗策略的相对有效性尚不清楚。本研究是第一项样本量足够的随机对照试验，以评估当前治疗策略对有症状的晚期颞下颌关节（TMJ）疾病患者的相对短期有效性：颞下颌关节盘移位无复位且张嘴受限。本建议在本随机对照试验中继续对受试者进行长期随访，以评估与该疾病的四种治疗策略相关的治疗结果。这些治疗策略包括：医疗管理（第一组）、非手术康复（第二组）、关节镜手术（第三组）和椎间盘收缩/修复手术（第四组）。受试者招募完成。96名受试者接受并完成了他们的治疗组分配。目前，随访检查和问卷调查已分别在治疗后3、6、9、12、18、24、36、48和60个月完成，每个随访期分别有93、90、87、94、85、81、73、57和49名受试者。目前5年随访失踪率约为15%。在本研究计划资助期开始时，所有受试者至少已参与研究2年。本研究的具体目的是比较四种治疗策略：1)下颌功能的客观测量，颅下颌指数（CMI），长期，5年和10年；2)TMJ疼痛的主观感知，通过应用TMJ疼痛症状严重程度指数（SSI-JT），长期，3、4、5、6、7、8、9和10年。初步分析将比较II、III和IV组与I组，以了解当初始治疗策略比I组（即医疗管理）更强化时，患者的预后是否得到改善。这项初步的短期分析比较了患者在3、6、9、12、18和24个月时的CMI和SSI-JT值，根据他们的初始治疗分配分组，发现与医疗管理相比，其他3种治疗策略无论是客观上还是主观上都没有改善结果。此外，相对于5年的随访，对主要结果测量的现有数据进行的条件功率分析预测，在此间隔内发现组间统计学显著差异的可能性很小。然而，我们认为5年的结果不足以评估这些治疗的终生效果。因此，需要对所有目前入组的受试者进行至少10年的长期随访，才能得出明确的结论。