Nove de Julho University, UNINOVE, São Paulo, SP, Brazil.
Federal University of Bahia, Vitória da Conquinta, BA, Brazil.
PLoS One. 2024 Oct 15;19(10):e0309073. doi: 10.1371/journal.pone.0309073. eCollection 2024.
Orofacial pain and tension headache are symptoms that affect a large portion of the population, compromising productivity, social ability, and functional development. The treatment for reducing painful sensation should be chosen carefully, as pharmacological treatment may bring side effects and overload the organism of patients in pain. Low-level laser therapy has been used with local and systemic [vascular] applications for pain control. However, there is still uncertainty in the literature about the ideal dosimetric parameters for photobiomodulation treatment according to patient characteristics.
The objective of this project is to validate a dosimetry model based on the relationship between the effects of photobiomodulation with anthropometric and hemodynamic variables, both in local application and systemic application in patients with symptoms of orofacial pain and tension headache. For this purpose, 180 participants with orofacial pain post-covid eligible participants will be randomly assigned to Group 1-Local Photobiomodulation, Group 2-Vascular Photobiomodulation, Group 3-Placebo Local Photobiomodulation, or Group 4-Placebo Vascular Photobiomodulation [Therapy EC-DMC device, São Carlos, Brazil,- 660 nm, 100mW] using stratified block randomization. Before the application, sociodemographic information such as age, skin phototype [classified by the Fitzpatrick scale], weight, height, body mass index [BMI], oxygen saturation [SaO2], blood pressure [BP], heart rate [HR], and thickness of skin, fat, and facial muscles will be collected. During the application, we will collect local temperature, SaO2, BP, and HR. Before and after laser application, blood levels of lactate and hemoglobin, BP, and HR will be measured in the first and last session. In addition to demographic, anthropometric, and hemodynamic variables, the penetrated energy will be quantified using a power meter, and information from orofacial pain and headache symptom questionnaires will be analyzed. The Monte Carlo simulation technique will be used to systematically study the relationship between the light penetration profile into the target tissues and the most relevant variables, namely BMI, tissue layer thicknesses, and skin phototype. Light transmittance, measured in vivo and simulated, will be compared to validate a personalized dosimetry model.
The results of this study contribute to validating a Monte Carlo Simulation model to calculate the appropriate dosimetry for photobiomodulation therapies in the control of patients with Post-Covid-19 orofacial pain.
Trial registration number: NCT06065969.
口面痛和紧张性头痛是影响很大一部分人群的症状，会降低他们的工作效率、社交能力和功能发育。为减轻疼痛而选择的治疗方法应该谨慎，因为药物治疗可能会带来副作用，并使疼痛患者的身体负担过重。低水平激光疗法已被用于局部和全身[血管]应用，以控制疼痛。然而，关于根据患者特征选择光生物调节治疗的理想剂量学参数，文献中仍存在不确定性。
本项目的目的是验证一个基于光生物调节效果与人体测量学和血液动力学变量之间关系的剂量学模型，这些变量包括局部应用和系统性应用于患有口面痛和紧张性头痛症状的患者。为此，将有 180 名符合条件的新冠后口面痛患者随机分配到 4 个组：局部光生物调节组 1、血管光生物调节组 2、局部安慰剂光生物调节组 3 和血管安慰剂光生物调节组 4[Therapy EC-DMC 设备，巴西圣保罗州圣卡洛斯市，660nm，100mW]。采用分层区组随机化方法进行分组。在应用之前，将收集社会人口统计学信息，如年龄、皮肤光型[根据 Fitzpatrick 量表分类]、体重、身高、体重指数[BMI]、血氧饱和度[SaO2]、血压[BP]、心率[HR]以及皮肤、脂肪和面部肌肉的厚度。在应用过程中，我们将收集局部温度、SaO2、BP 和 HR。在激光应用前后，将在第一和最后一次治疗中测量血液中乳酸和血红蛋白的水平、BP 和 HR。除了人口统计学、人体测量学和血液动力学变量外，还将使用功率计定量测量穿透能量，并分析口面痛和头痛症状问卷的信息。将使用蒙特卡罗模拟技术系统地研究光穿透目标组织的分布与最相关变量（即 BMI、组织层厚度和皮肤光型）之间的关系。将比较体内测量和模拟的光透射率，以验证个性化剂量学模型。
本研究的结果有助于验证一种蒙特卡罗模拟模型，以计算新冠后口面痛患者光生物调节治疗的适当剂量。
试验注册号：NCT06065969。
