Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

BACKGROUND: This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD). METHODS: This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1-ILIB with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 2-Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 3-Control with no treatment (n = 15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ± 20%, wavelength 808 nm ± 10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures. DISCUSSION: Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.

Effect of photobiomodulation on fatigue in individuals with relapsing-remitting multiple sclerosis: a pilot study.

Multiple sclerosis is an autoimmune disease of the central nervous system characterized by inflammation and destruction of the myelin sheath. Fatigue is one of the main symptoms of this disease, with a negative impact on quality of life and few treatment options. Photobiomodulation is used for several inflammatory conditions and may be beneficial for the treatment of fatigue in individuals with multiple sclerosis. Conduct a pilot study to analyze the effect of photobiomodulation on fatigue in individuals with relapsing-remitting multiple sclerosis. The participants were recruited from the UNINOVE Integrated Health Clinic and randomly allocated to two groups: group 1, administration of photobiomodulation (808 nm, 36 J for 360 s) under the tongue and group 2, administration of photobiomodulation over the radial artery. Fatigue was measured using the Modified Fatigue Impact Scale (MFIS). No significant differences were found regarding the total MFIS score or subscale scores (p < 0.05, two-way ANOVA). Photobiomodulation with the parameters employed in the present study had no effect on fatigue in individuals with multiple sclerosis. ClinicalTrials.gov Identifier: NCT03360487.

The Effect of Photobiomodulation on Analgesia During Childbirth: A Controlled and Randomized Clinical Trial.

Background: Pain during labor can be a barrier when choosing vaginal delivery. In an attempt to relief pain during labor, several pharmacological and nonpharmacological methods are proposed. Objective: To assess the effect of light-emitting diode (LED) photobiomodulation on analgesia during labor. Methods: A clinical trial was conducted with 29 women who were divided into two groups: G1 (experimental group-LED) and G2 (control group-hot shower). In the experimental group, an LED plate with red and infrared merged [red 660 ± 20 nm, 5 mW/cm2, 3 J per LED (108 J) and infrared 850 ± 20 nm, 5 mW/cm2, 3 J per LED (108 J), total energy = 216 J] was placed on the subjects' dorsal region, at the level of T10 to S4, for 10 min, with the plate automatically turning off. Hot shower at controlled temperature was offered for 30 min. To verify the effect of LED on analgesia during labor, the following variables were assessed: (1) perception of pain, (2) fetal well-being assessed by cardiotocography or intermittent auscultation of fetal heart rate, (3) Apgar score at minutes 1 and 5 after birth, and (4) labor duration. Results: There was a statistically significant difference (p < 0.05) in pain reduction evidenced by a millimetric visual scale, before and after application on G1-LED (7.92 ± 1.78). Regarding the other variables, there was no statistical difference between the groups when comparing fetal well-being, Apgar score and labor duration. Conclusions: It is concluded that LED can be considered an alternative, since it caused pain reduction without changing other parameters during labor, compared with hot shower, a method included in hospital protocols, proving to be safe. Clinical Trial Registration number: NCT03496857.

Effect of Photobiomodulation on Salivary Cortisol, Masticatory Muscle Strength, and Clinical Signs in Children with Sleep Bruxism: A Randomized Controlled Trial.

Background: The diagnosis of sleep bruxism (SB) in children is difficult due to the lack of a polysomnographic protocol for this population. Moreover, the gold standard treatment [occlusal splint (OS) therapy] has limitations, as adequate use depends on the child's cooperation. The etiology of SB may include stress factors. Salivary cortisol is a biomarker used as a noninvasive method to evaluate the response to stress. Besides physiological aspects, it is also important to investigate morphological aspects, such as masticatory muscle strength. The aim of the present study was to determine the occurrence of bite marks on the buccal mucosa in children as a complementary sign for the diagnosis of SB and investigate and the effectiveness of photobiomodulation as an alternative treatment for this condition. Methods: Seventy-six children 6-12 years of age were divided into four groups: G1-with SB and submitted to laser therapy over acupuncture points (λ = 786.94 nm, 20 sec per point, fluency = 33.5 Jcm2, energy = 1 J, number of points = 12); G2-with SB, use of OS, G3-with SB and submitted to sham laser therapy; and G4-control group without SB. Clinical signs (bite marks on buccal mucosa and headaches), bite force (BF), and salivary cortisol (biomarker of stress) were evaluated before and after treatment. Statistical analysis involved the Kolmogorov-Smirnov, Shapiro-Wilk, and analysis of variance (ANOVA) tests. Results: Bite marks on the buccal mucosa were significantly associated with SB (p < 0.001). A statistically significant difference was found between the frequency of children with headache before and after treatment in G1 (p = 0.0005) and G2 (p = 0.0001), with no significant differences between the two groups (G1 and G2). The children in G1 had lower BF on both sides compared to the other groups. In the intragroup analysis after treatment, all groups exhibited an increase in salivary cortisol levels. Conclusions: Bite marks on the buccal mucosa can be used as a complementary sign for the clinical diagnosis of SB. Children with SB responded well to photobiomodulation therapy, as evidenced by the reduction in BF and reports of headache.

Effects of photobiomodulation on interleukin-10 and nitrites in individuals with relapsing-remitting multiple sclerosis - Randomized clinical trial.

OBJECTIVE: Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease. The modulation of IL-10 and nitrites through treatment with PBM may be a novel treatment modality for MS. METHODS: A randomized, uncontrolled, clinical trial was conducted involving 14 individuals with a diagnosis of Relapsing-Remitting MS and a score of up to 6.0 on the Expanded Disability Status Scale (EDSS). THE PARTICIPANTS WERE RANDOMIZED TO TWO GROUPS: Group 1 -PBM in the sublingual region; Group 2 -PBM over the radial artery. Irradiation was administered with a wavelength of 808 nm and output power of 100 mW for 360 seconds twice a week, totaling 24 sessions. Peripheral blood was analyzed for the determination of serum levels of IL-10 and nitrites. RESULTS: After treatment with PBM, the expression of IL-10 increased in both the sublingual group (pre-treatment: 2.8 ± 1.4 pg/ml; post-treatment: 8.3 ± 2.4 pg/ml) and the radial artery group (pre-treatment: 2.7 pg/ml ± 1.4; post-treatment: 11.7 ± 3.8 pg/ml). In contrast, nitrite levels were not modulated in the sublingual group (pre-treatment: 65 ± 50 nmol/mg protein; post-treatment: 51 ± 42 nmol/mg protein) or the radial artery group (pre-treatment: 51 ± 16 nmol/mg protein; post-treatment: 42 ± 7 nmol/mg protein). CONCLUSION: Treatment with PBM positively modulated the expression of IL-10 but had no effect on nitrite levels. Further studies should be conducted with a larger sample and a control group, as PBM may be a promising complementary treatment for the management of MS. This trial is registered at ClinicalTrials.gov. Identifier: NCT03360487.

Sensory and motor responses after photobiomodulation associated with physiotherapy in patients with incomplete spinal cord injury: clinical, randomized trial.

Complete or incomplete spinal cord injury (SCI) results in permanent neurological deficits due to the interruption of nerve impulses, causing the loss of motor and sensory function, which leads to a reduction in quality of life. The focus of rehabilitation for such individuals is to improve quality of life and promote functional recovery. Photobiomodulation (PBM) has proved to be promising complementary treatment in cases of SCI. The aim of the present study was to investigate the effects of PBM combined with physiotherapy on sensory-motor responses below the level of the injury and quality of life in individuals with SCI. Thirty participants were randomized for allocation to the PBM group (active PBM + physiotherapy) or sham group (sham PBM + physiotherapy). Physiotherapy was administered three times a week. Sensitivity and motor skills were evaluated using the ASIA impairment scale. Quality of life was assessed using the WHOQOL-BREF questionnaire. The data were analyzed with the level of significance set to 5%. Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group. The results of the WHOQOL-BREF questionnaire revealed a significant difference in general quality of life favoring the active PBM group over the sham group after treatment. Physiotherapy combined with PBM leads to better sensory-motor recovery in patients with SCI as well as a better perception of health and quality of life. Trial registration identifier: NCT03031223.

Effects of Photobiomodulation in Children with Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial: Study protocol clinical trial (SPIRIT compliant).

Hypotonia, particularly of the masticatory and oropharyngeal muscles, is 1 of the main characteristics of Down Syndrome (DS), resulting in impaired speech, chewing and swallowing. Moreover, the complete or partial obstruction of the airways during sleep may occur due to hypotonia of the tongue, leading to snoring and sleep disorders, such as obstructive apnea and sleep bruxism. OBJECTIVE:: Analyze salivary levels of dopamine and cortisol and muscle activity before and after treatment with low-level laser therapy administered to acupoints in children with DS. METHODS:: A randomized, controlled, clinical trial will be conducted. Individuals 4 to 17 years of age with a diagnosis of DS and possible sleep bruxism will be screened at the Integrated Health Clinic of Nove de Julho University. We will evaluate orofacial dysfunction (Nordic Orofacial Test - Screening questionnaire), Masseter muscle activity during sleep will be assessed by BiteStrip and the masticatory muscles will be evaluated by electromyography (BTS TMJOINT) head posture as well as salivary cortisol and dopamine. After the evaluations, the participants will be randomized into 2 groups: Grupo 1 - treatment with low-level laser therapy at a wavelength of 808 nm; Group 2 - sham treatment (simulated laser therapy). Treatment will be conducted twice per week for a total of 12 sessions. The data will be tabulated and treated using GraphPad Prism version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation. The ANOVA 2-way will be used for comparisons between the groups, with the significance level set to 5% (P < .05).ClinicalTrials registration number: NCT04211870.

"Efficacy of photodynamic therapy on the treatment of herpes labialis: A systematic review".

OBJECTIVE: We conducted a systematic review to evaluate the efficacy of PDT in the management of recurrent herpes labialis (RHL). STUDY DESIGN: systematic review. METHODS: This study was reported according to the PRISMA checklist and we performed a literature search on five databases. RESULTS: The search revealed that there are no published clinical trials addressing PDT on RHL, therefore we conducted a review of case reports and five studies were included for qualitative review. The number of treated patients varied from 2 to 6 in each article. Most studies used methylene blue as a photosensitizer, while one used 5-aminolevulinic acid. For light irradiation, most studies used laser and one used a red light from halogen lamp. Patients' follow-up varied from 24 h to 12 months. All articles reported good outcomes with resolution of disease and no recurrences. Only one study reported adverse effects during treatment (burning and pain). CONCLUSION: The results of this review suggest that PDT could be an effective treatment for herpes labialis. However, due to very few case reports and heterogeneity among protocols, there is a call for well-designed randomized clinical trials to confirm the efficacy of this therapy and to establish standardized protocols. The review protocol was registered at the International Prospective Register of Systematic Reviews (PROSPERO) under number CRD CRD42018108973.

Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial.

BACKGROUND: Multiple sclerosis (MS) is an autoimmune disease, for which the forms of treatment are medication and rehabilitation. However, in vitro and in vivo studies have demonstrated that photobiomodulation can be an effective treatment modality for inflammatory diseases, including MS. Photobiomodulation has a broad range of benefits, such as the avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions in pain, edema and inflammation, cell proliferation, and even apoptosis. The outcomes of photobiomodulation include the regeneration of cells, the stimulation of the growth of Schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric oxide levels, and the upregulation of the cytokine IL10, demonstrating that this therapeutic modality can offer neuroprotection. METHODS: A randomized, controlled, double-blind, clinical trial is proposed. The patients will be divided into 6 groups. Groups 1 and 2 will receive sham and active photobiomodulation in the sublingual region, respectively. Groups 3 and 4 will receive sham and active photobiomodulation along the spinal cord, respectively. Group 5 will receive placebo treatment with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. Group 6 will be treated with photobiomodulation on the skin in the region of the radial artery. DISCUSSION: Treatment for MS is directed at the immune response and slowing the progression of the disease. This is one of the first clinical trials involving photobiomodulation in the sublingual region and along the spinal cord, which could help establish a promising new form of nonpharmacological treatment for autoimmune diseases. This is one of the first clinical trials with sublingual photobiomodulation and along the spinal cord that could help establish a new form of promising treatment of the disease associated with pharmacological treatment.

Photobiomodulation improves motor response in patients with spinal cord injury submitted to electromyographic evaluation: randomized clinical trial.

Photobiomodulation is a treatment that has been widely used in neurotrauma and neurodegenerative diseases. In the present study, low-level laser therapy was administered to patients with spinal cord injury. Twenty-five individuals were divided into two groups: placebo photobiomodulation plus physiotherapy and active photobiomodulation plus physiotherapy. Electromyographic evaluations were performed before and after 12 sessions of phototherapy as well as 30 days after the end of treatment. In the active phototherapy group, median frequency values of the brachial biceps and femoral quadriceps muscles were higher at rest and during isotonic contraction 30 days after photobiomodulation (p = 0.0258). No significant results were found regarding the rest and isotonic conditions in the pre-photobiomodulation period (p = 0.950) or immediately following photobiomodulation (p = 0.262). The data provide evidence that phototherapy improves motor responses in individuals with spinal cord injury, as demonstrated by differences in the EMG signal before and after treatment. TRIAL REGISTRATION: NCT 03031223.