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: 10518594
• 负责人: Roger B Fillingim
• 金额: $ 55.94万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10518594
• 关键词: Adult; Advertisements; Affect; Aftercare; Age; Analgesics; Anti-Inflammatory Agents; Arthralgia; Biological; Blood; Blood flow; Chronic; Chronic disabling pain; Clinical; Clinical Trials; Communities; Complex; Computer Assisted; Development; Dose; Dose-Rate; Double-Blind Method; Drug Prescriptions; Effectiveness; Evidence based treatment; Face; Goals; Health Care Costs; Heterogeneity; Hospitalization; Inflammation; Inflammatory; Inflammatory Response; Informed Consent; Injection of therapeutic agent; Injections; Internet; Jaw; Lasers; Lead; Lymphatic function; Mechanics; Mediating; Medical History; Meta-Analysis; Methodology; Modality; Morbidity - disease rate; Musculoskeletal Diseases; Musculoskeletal Pain; Myalgia; Natural regeneration; Neural Pathways; Nociception; Operative Surgical Procedures; Opioid; Orthodontic; Pain; Pain Threshold; Pain intensity; Pain interference; Pain management; Participant; Pathway interactions; Patients; Peripheral; Persons; Phototherapy; Placebos; Population; Pre-Clinical Model; Protocols documentation; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Reporting; Research Design; Schedule; Site; Spinal Cord; Steroids; System; TMD treatment; Telephone; Temporomandibular Joint Disorders; Temporomandibular joint disorder pain; Testing; Therapeutic; Therapeutic Effect; Trauma; Treatment Efficacy; Treatment outcome; Trigeminal System; Visit; Visual; analog; base; chronic painful condition; clinical examination; clinical pain; common treatment; comparison group; craniofacial; cytokine; diagnostic criteria; effective therapy; efficacy evaluation; eligible participant; experience; follow-up; improved; injured; interest; multimodality; orofacial; pain sensitivity; patient population; photobiomodulation; pressure; primary outcome; recruit; response; screening; secondary outcome; side effect; symptomatology; treatment effect; treatment response; trial design; trigger point; Adult; Advertisements; Affect; Aftercare; Age; Analgesics; Anti-Inflammatory Agents; Arthralgia; Biological; Blood; Blood flow; Chronic; Chronic disabling pain; Clinical; Clinical Trials; Communities; Complex; Computer Assisted; Development; Dose; Dose-Rate; Double-Blind Method; Drug Prescriptions; Effectiveness; Evidence based treatment; Face; Goals; Health Care Costs; Heterogeneity; Hospitalization; Inflammation; Inflammatory; Inflammatory Response; Informed Consent; Injection of therapeutic agent; Injections; Internet; Jaw; Lasers; Lead; Lymphatic function; Mechanics; Mediating; Medical History; Meta-Analysis; Methodology; Modality; Morbidity - disease rate; Musculoskeletal Diseases; Musculoskeletal Pain; Myalgia; Natural regeneration; Neural Pathways; Nociception; Operative Surgical Procedures; Opioid; Orthodontic; Pain; Pain Threshold; Pain intensity; Pain interference; Pain management; Participant; Pathway interactions; Patients; Peripheral; Persons; Phototherapy; Placebos; Population; Pre-Clinical Model; Protocols documentation; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Reporting; Research Design; Schedule; Site; Spinal Cord; Steroids; System; TMD treatment; Telephone; Temporomandibular Joint Disorders; Temporomandibular joint disorder pain; Testing; Therapeutic; Therapeutic Effect; Trauma; Treatment Efficacy; Treatment outcome; Trigeminal System; Visit; Visual; analog; base; chronic painful condition; clinical examination; clinical pain; common treatment; comparison group; craniofacial; cytokine; diagnostic criteria; effective therapy; efficacy evaluation; eligible participant; experience; follow-up; improved; injured; interest; multimodality; orofacial; pain sensitivity; patient population; photobiomodulation; pressure; primary outcome; recruit; response; screening; secondary outcome; side effect; symptomatology; treatment effect; treatment response; trial design; trigger point

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 鉴于缺乏有效治疗的TMD和止痛药过度使用，精心设计的研究是 需要评估非药理替代方法来治疗这种常见和残疾的慢性疼痛状况。 我们在这项研究中的目标是进行多模式的双盲，假对照，随机临床试验 用于TMD疼痛的光生物调节（PBM）。另外，我们建议确定PBM诱导的变化是否 炎症和疼痛敏感性有助于PBM的镇痛作用。总共130位TMD参与者将 通过基于社区的广告招募。参与者将完成计算机辅助电话 筛选（CATI）。合格的参与者将年龄在18岁及以上，疼痛强度≥30在视觉模拟量表上 （0-100）。如果以下情况，将排除参与者 CATI前30天内的疼痛； b）使用注射疗法（例如，嫩或触发点注射，类固醇 注射）用于在CATI前2周内治疗疼痛； c）开始咬合器具疗法 在CATI前30天内； d）在CATI前6周内，面部创伤或口交手术的病史； e）活动 正畸治疗； f），筛查前一年的精神病医院。参与者有资格 在安排CATI进行前随机访问（V0），八次治疗访问（V1至V8）之后，一次 治疗访问（V9），1和3个月的互联网/电话随访以及六个月的随访临床访问（v10）。 V0将包括知情同意，填写详细的病史以及评估临床疼痛和 干扰，参与者将完成疼痛，享受，一般活动（PEG）量表，然后进行临床 根据TMD的诊断标准（DC/TMD）确认TMD状态的考试，压力疼痛敏感性 （PPT）和抽血。 V1将是接收PBM或安慰剂的随机访问。 V2-V8是治疗 访问。 V5也是中途访问，因此，将进行抽血，DC/TMD考试和PPT 治疗。在V9（治疗后访问）中，将评估治疗后结果，PEG，DC/TMD考试，PPT 和抽血。 PBM/安慰剂治疗：我们将使用三种类型的活动/安慰剂问题； a）单个激光 808 nm，4.75W/cm 2; b）激光簇，五x 810 nm，5.96W/cm 2和四个LED 660nm，0.05W/cm 2和2; c）LED 群集，56 x 660nm 0.51W/cm2和48 850nm，0.45W/cm2，950MW总计应用于多个颅面位置。 分析将确定对主要结局（疼痛强度）和多个次级的治疗效果 结果并将检查，探索性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发现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。