Photobiomodulation for the management of Temporomandibular disorder pain

项目概要/摘要 由于缺乏有效的治疗TMD和过度使用止痛药，精心设计的研究， 需要评估非药物替代品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双盲，假对照，随机临床试验的多模式 光生物调节（PBM）治疗TMD疼痛。此外，我们建议确定PBM是否会引起细胞内的变化 炎症和疼痛敏感性有助于PBM的镇痛作用。共有130名TMD参与者将在 通过社区广告招募。参与者将完成一个计算机辅助电话 筛选（CATI）。合格的受试者年龄为18岁及以上，视觉模拟量表疼痛强度≥ 30 （0 - 100）。受试者将被排除，如果：a）开始新的每日处方药管理 CATI前30天内的疼痛; B）使用注射疗法（例如，触痛或触发点注射，类固醇 注射）用于在CATI之前2周内管理疼痛; c）开始咬合矫正器治疗 CATI前30天内; d）CATI前6周内有面部创伤或口面手术史; e）活动性 正畸治疗; f）筛查前一年内精神病住院治疗。符合资格的参与者 CATI后，将安排1次随机化前访视（V0）、8次治疗访视（V1至V8）、1次治疗后访视（V1至V8）， 治疗访视（V9）、1个月和3个月时的互联网/电话随访以及6个月随访临床访视（V10）。 V0将包括知情同意、填写详细病史和评估临床疼痛， 干预后，参与者将完成疼痛、享受、一般活动（PEG）量表，然后进行临床评估。 根据TMD诊断标准（DC/TMD）、压痛敏感性检查确认TMD状态 (PPT)和抽血V1将是接受PBM或安慰剂的随机化访视。V2-V8为治疗 探访V5也是中途访视，因此，在访视前将进行抽血、DC/TMD检查和PPT 治疗在V9（治疗后访视）时，将评估治疗后结局、PEG、DC/TMD检查、PPT 和抽血PBM/安慰剂治疗：我们将使用三种类型的有源/安慰剂探头; A）单激光 808 nm，4.75 W/cm 2; B）激光束，5个x 810 nm，5.96 W/cm 2和4个LED 660 nm，0.05 W/cm 2; C）LED 簇，56 X 660nm，0.51W/cm 2和48 850nm，0.45W/cm 2，950mW总应用于多个颅面部位。 分析将确定治疗对主要结局（疼痛强度）和多个次要结局的影响。 结果，并将探索性地检查炎症和疼痛敏感性的变化是否介导 治疗反应。这项严格设计的试验的结果将提供迄今为止最明确的证据 关于PBM治疗TMD疼痛的有效性和机制。

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.