Photobiomodulation for the management of Temporomandibular disorder pain

光生物调节治疗颞下颌关节紊乱病疼痛

• 批准号: 10830073
• 负责人: Roger B Fillingim
• 金额: $ 71.39万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10830073
• 关键词: Photobiomodulation; management; Temporomandibular; disorder; pain

Project Summary/Abstract Given the paucity of effective treatments for TMD and the overuse of pain medication, well-designed studies are needed to evaluate non-pharmacological alternatives to treat this common and disabling chronic pain condition. Our goal in this study is to conduct a double-blind, sham-controlled, randomized clinical trial of multimodal Photobiomodulation (PBM) for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation and pain sensitivity contribute to PBM’s analgesic effects. A total of 130 TMD participants will be recruited through community-based advertisements. Participants will complete a computer-assisted telephone screening (CATI). Eligible participants will be age 18 and older with pain intensity of ≥30 on a visual analog scale (0-100). Participants will be excluded if: a) starting a new daily prescription medication for the management of pain within 30 days before CATI; b) use of injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks before the CATI; c) starting occlusal appliance therapy within 30 days before CATI; d) history of facial trauma or orofacial surgery within 6 weeks before CATI; e) active orthodontic treatment; f), psychiatric hospitalization within one year before the screening. Participants eligible after CATI will be scheduled for a pre-randomization visit (V0), eight treatment visits (V1 to V8), one post- treatment visit (V9), an internet/ phone follow-up at 1 and 3 months, and six-month follow-up clinical visit (V10). V0 will include informed consent, completion of a detailed medical history and to assess clinical pain and interference, participants will complete the Pain, Enjoyment, General Activity (PEG) Scale followed by a clinical exam to confirm TMD status according to the Diagnostic Criteria for TMD (DC/TMD), Pressure Pain Sensitivity (PPT) and blood draw. V1 will be the randomization visit to either receive PBM or Placebo. V2-V8 are treatment visits. V5 is also the Midway visit, therefore, a blood draw, DC/TMD exam and PPT will be performed before treatment. At V9 (post-treatment visit), post-treatment outcomes will be assessed, PEG, DC/TMD exam, PPT and a blood draw. PBM/Placebo treatment: We will use three types of active/Placebo probes; A) Single Laser 808 nm, 4.75W/cm 2; B) Laser Cluster, five x 810 nm, 5.96W/cm 2 and four LED 660nm, 0.05W/cm 2and; C) LED Cluster, 56 X 660nm 0.51W/cm2 and 48 850nm, 0.45W/cm2, 950mW total applied to multiple craniofacial sites. Analyses will determine treatment effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine, exploratorily, whether changes in inflammation and pain sensitivity mediate treatment response. Findings from this rigorously designed trial will provide the most definitive evidence to date regarding the effectiveness and mechanisms of PBM for treating TMD pain.

项目摘要/摘要 考虑到TMD缺乏有效的治疗方法和过度使用止痛药，精心设计的研究是 需要评估非药物替代方案来治疗这种常见和致残的慢性疼痛状况。 我们在这项研究中的目标是进行一项多模式的双盲、假对照、随机临床试验。 光生物调节(PBM)治疗TMD疼痛。此外，我们还建议确定PBM是否会导致 炎症和疼痛敏感性与PBM的止痛作用有关。总计130名TMD参与者将是 通过基于社区的广告招募。参与者将完成一部计算机辅助电话 筛查(CATI)。符合条件的参与者年龄为18岁及以上，在视觉模拟评分中疼痛强度为≥30 (0-100)。在下列情况下，参与者将被排除在外：a)开始服用新的每日处方药以管理 CATI前30天内疼痛；b)使用注射疗法(例如，压痛或触发点注射，类固醇 注射)在CATI前2周内用于止痛；c)开始咬合矫治器治疗 CATI前30天内；d)CATI前6周内面部创伤或口腔手术病史；e)活动 正畸治疗；f)筛查前一年内精神科住院治疗。参与者符合条件 在CATI将被安排进行随机前访问(V0)、8次治疗访问(V1至V8)、1次后- 治疗访视(V9)，1个月和3个月的互联网/电话随访，以及6个月的临床随访(V10)。 V0将包括知情同意、完成详细的病史并评估临床疼痛和 干预后，参与者将完成疼痛、快乐、一般活动(PEG)量表，然后进行临床 根据TMD诊断标准(DC/TMD)进行检查以确认TMD状态、压痛敏感性 (Ppt)和抽血。V1将是接受PBM或安慰剂的随机访问。V2-V8是治疗 来访。V5也是中途来访，因此，之前将进行抽血、DC/TMD检查和PPT 治疗。在V9(治疗后访问)时，将评估治疗后的结果，进行聚乙二醇法、DC/TMD检查、PPT 还有抽血。PBM/安慰剂治疗：我们将使用三种类型的主动/安慰剂探头；A)单一激光 808 nm，4.75W/cm2；B)激光簇，五个x 810 nm，5.96W/cm2和四个LED 660 nm，0.05W/cm2和；C)LED 团簇，56×660 nm，0.51W/cm2；48 850 nm，0.45W/cm2,950 mW，用于多个颅面部位。 分析将确定对主要结果(疼痛强度)和多个继发性疾病的治疗效果 结果，并将探索性地检查炎症和疼痛敏感度的变化是否起中介作用 治疗反应。这项精心设计的试验结果将提供迄今为止最确凿的证据。 关于PBM治疗TMD疼痛的有效性和机制。