FOUR TREATMENT STRATEGIES FOR TMJ DISK DISPLACEMENT

颞下颌关节紊乱病（TMD）的治疗在非手术和手术干预之间存在差异。 后续研究表明，这两种干预措施都取得了积极成果。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。本研究是第一项具有足够样本量的随机对照试验，用于评估症状性晚期颞下颌关节（TMJ）疾病受试者当前治疗策略的相对短期有效性：TMJ盘移位未复位，张口受限。该建议是在本RCT中继续对受试者进行长期随访，以评价与该疾病的四种治疗策略相关的治疗结局。这些治疗策略是：医疗管理（I组）、非手术康复（II组）、关节镜手术（III组）和椎间盘折叠/修复手术（IV组）。受试者招募已完成。96例受试者接受并完成了治疗组分配。目前，在治疗后3、6、9、12、18、24、36、48和60个月，分别有93、90、87、94、85、81、73、57和49例受试者在每个随访间隔完成了随访检查和问卷调查。目前5年失访率约为15%。在本研究的拟定资助期开始时，所有受试者均已参与研究至少2年。拟议研究的具体目的是根据以下方面比较四种治疗策略：1）颌功能的客观测量，颅下颌指数（CMI），长期，5年和10年，和2）TMJ疼痛的主观感觉，通过应用TMJ疼痛症状严重程度指数（SSI-JT）测量，长期，3，4，5，6，7，8，9年和10年。主要分析将比较第II、III和IV组与第I组，以观察初始治疗策略比第I组更强化（即，药物管理）时患者结局是否得到改善。该主要短期分析比较了根据初始治疗分配分组的患者在3、6、9、12、18和24个月时的CMI和SSI-JT值，发现与药物管理相比，其他3种治疗策略在客观或主观上均未改善结局。此外，相对于5年随访，根据主要结局指标的可用数据进行的条件把握度分析预测，在该时间间隔发现组间统计学显著差异的可能性很小。然而，我们认为5年结果不足以评估这些治疗的终生效应。因此，需要对所有目前入组的受试者完成至少10年的长期随访，才能得出明确的结论。

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.