A phytotherapic blend immunity-6™ inhibits myeloid leukemic cells 2 activation involving purinergic signaling.

Leukemia is among the most common types of hematological cancers and the use of herbal medicines to prevent and treat leukemia are under quick development. Among several molecular pathways involved in leukemia pathogenesis and exacerbations, purinergic signaling is revealed as a key component. In the present study, the effects of two doses (5 ug/mL and 10 ug/mL) of Immunity-6™, a phytocomplex composed by beta-glucan, green tea (Camelia sinensis), chamomile (Matricaria chamomilla), and ascorbic acid (vitamin C) was tested in vitro, using chronic myelogenous leukemia cell line (K-562; 5 ×104/mL/well), which were challenged with lipopolysaccharide (LPS; 1 ug/mL) for 24 h. The results demonstrated that both doses of Immunity-6™ inhibited ATP release (p < 0.001) and P2×7 receptor at mRNA levels expression (p < 0.001). Purinergic inhibition by Immunity-6™ was followed by reduced release of proinflammatory cytokines IL-1beta (p < 0.001) and IL-6 (p < 0.001), while only 5 ug/mL of Immunity-6™ reduced the release of TNF-alpha (p < 0.001). Beyond to inhibit the release of pro-inflammatory cytokines, both doses of Immunity-6™ induced the release of anti-inflammatory cytokine IL-10 (p < 0.001), while only the higher dose (10 ug/mL) of Immunity-6™ induced the release of anti-inflammatory IL-1ra (p < 0.05) and klotho (p < 0.001). Thus, Immunity-6™ may be a promising adjuvant in the treatment of leukemia and further clinical trials are guaranteed.

Brain activity and upper limb movement analysis in children with Down syndrome undergoing transcranial direct current stimulation combined with virtual reality training: study protocol for a randomized controlled trial.

BACKGROUND: Children with Down syndrome have poorer functional and sensory skills compared to children with typical development. Virtual reality (VR) training could help improve these skills. Moreover, transcranial direct current stimulation (tDCS) has achieved promising results in terms of enhancing the effects of physical and sensory therapy by modulating cortical excitability. METHODS/DESIGN: Two investigations are proposed: (1) an observational study with a convenience sample consisting of children with Down syndrome (group 1-cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence) and children with typical development 6 to 12 years of age (group 2). Both groups will undergo evaluations on a single day involving a three-dimensional analysis of upper limb movements, an analysis of muscle activity of the biceps and brachial triceps muscles and an analysis of visuospatial and cognitive-motor variables. (2) Analysis of clinical intervention: a pilot study and clinical trial will be conducted involving individuals with Down syndrome (cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence). The sample will be defined after conducting a pilot study with the same methodology as that to be used in the main study. The participants will be randomly allocated to two groups: An experimental group submitted to anodal tDCS combined with a VR game and a manual motor task and a control group submitted to sham tDCS combined with a VR game and a manual motor task. The training protocol will involve 10 sessions of active or sham tDCS during memory and motor task games. Three 20-min sessions will be held per week for a total of 10 sessions. Evaluations will be performed on three different occasions: pre-intervention, post-intervention (after 10 sessions) and follow-up (1 month after the intervention). Evaluations will consist of analyses of electroencephalographic signals, electromyographic signals of the biceps and triceps brachii, and the three-dimensional reconstruction of the reaching movement. The results will be analyzed statistically with the significance level set at 5% (p ≤ 0.05). DISCUSSION: The optimization of the results obtained with virtual reality training is believed to be related to the interactive experience with a wide range of activities and scenarios involving multiple sensory channels and the creation of exercises, the intensity of which can be adjusted to the needs of children. Therefore, the proposed study aims to complement the literature with further information on tDCS and VR training considering different variables to provide the scientific community with clinical data on this combination of interventions. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (REBEC) protocol number RBR-43pk59 registered on 2019 March 27 https://ensaiosclinicos.gov.br/rg/RBR-43pk59 and Human Research Ethics Committee number 3.608.521 approved on 2019 September 30. Protocol version 2021 October 20. Any changes to the protocol will be reported to the committees and approved. Informed consent will be obtained from all participants by the clinical research coordinator and principal investigator.

Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor.

Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by irreversible airflow limitation, airway inflammation and remodeling, and enlargement of alveolar spaces. COPD is in the top five leading causes of deaths worldwide and presents a high economic cost. However, there are some preventive measures to lower the risk of developing COPD. Low-level laser therapy (LLLT) is a new effective therapy, with very low cost and no side effects. So, our objective was to investigate if LLLT reduces pulmonary alterations in an experimental model of COPD. C57BL/6 mice were submitted to cigarette smoke for 75 days (2x/day). After 60 days to smoke exposure, the treated group was submitted to LLLT (diode laser, 660 nm, 30 mW, and 3 J/cm2) for 15 days and euthanized for morphologic and functional analysis of the lungs. Our results showed that LLLT significantly reduced the number of inflammatory cells and the proinflammatory cytokine secretion such as IL-1ß, IL-6, and TNF-α in bronchoalveolar lavage fluid (BALF). We also observed that LLLT decreased collagen deposition as well as the expression of purinergic P2X7 receptor. On the other hand, LLLT increased the IL-10 release. Thus, LLLT can be pointed as a promising therapeutic approach for lung inflammatory diseases as COPD.

Randomized, blinded, controlled trial on effectiveness of photobiomodulation therapy and exercise training in the fibromyalgia treatment.

This study evaluated the role of the phototherapy and exercise training (EXT) as well as the combined treatment in general symptoms, pain, and quality of life in women suffering from fibromyalgia (FM). A total of 160 women were enrolled and measures were carried out in two sets: it was sought to identify the acute effect for a single phototherapy and EXT session (Set 1); long-term effect (10 weeks) of the interventions (Set 2). Phototherapy irradiation was performed at 11 locations in their bodies, employing a cluster with nine diodes (one super-pulsed infrared 905 nm, four light-emitting diodes [LEDs] of 640 nm, and four LEDs of 875 nm, 39.3 J per location). Algometry and VAS instrument were applied to evaluate pain. The FM symptoms were evaluated with Fibromyalgia Impact Questionnaire (FIQ) and Research Diagnostic Criteria (RDC) instruments. Quality of life was assessed through SF-36 survey. Set 1: pain threshold was improved with the phototherapy, and EXT improved the pain threshold for temporomandibular joint (right and left body side) and occipital site (right body side). Set 2: there was improved pain threshold in several tender points with the phototherapy and EXT. There was an overlap of therapies to reduce the tender point numbers, anxiety, depression, fatigue, sleep, and difficulty sleeping on FIQ/RDC scores. Moreover, quality of life was improved with both therapies. The phototherapy and EXT improved the pain threshold in FM women. A more substantial effect was noticed for the combined therapy, in which pain relief was accomplished by improving VAS and FIQ scores as well as quality of life.

Photobiomodulation therapy improves both inflammatory and fibrotic parameters in experimental model of lung fibrosis in mice.

Lung fibrosis (LF) is a chronic and progressive lung disease characterized by pulmonary parenchyma progressive lesion, inflammatory infiltration, and interstitial fibrosis. It is developed by excessive collagen deposition and other cellular matrix components, resulting in severe changes in the alveolar architecture. Considering the absence of effective treatment, the aim of this study was to investigate the effect of photobiomodulation therapy (PBMT) on the development of PF. For this purpose, we used C57BL6 mice subjected to induction of LF by bleomycin administration (1.5 U/kg) by orotracheal route and, after 14 days of the induction, mice were treated with PBMT applied to the thorax 1×/day for 8 days (wavelength 660 ± 20 nm, power 100 mW, radiant exposure 5 J/cm2, irradiance 33.3 mW/cm2, spot size 2.8cm2, total energy 15 J, time of irradiation: 150 s) and inflammatory and fibrotic parameters were evaluated with or without PBMT. Our results showed that PBMT significantly reduced the number of inflammatory cells in the alveolar space, collagen production, interstitial thickening, and static and dynamic pulmonary elastance. In addition, we observed reduced levels of IL-6 e CXCL1/KC released by pneumocytes in culture as well as reduced level of CXCL1/KC released by fibroblasts in culture. We can conclude that the PBMT improves both inflammatory and fibrotic parameters showing a promising therapy which is economical and has no side effects.

Upper Airway Collapsibility Assessed by Negative Expiratory Pressure while Awake is Associated with Upper Airway Anatomy.

STUDY OBJECTIVES: There is a growing interest to develop a simple method to characterize the mechanisms leading to upper airway collapse in order to guide treatment options in patients with obstructive sleep apnea (OSA). Critical closing pressure (Pcrit) during sleep is able to predict the anatomical component of OSA. However, Pcrit is a laborious method that is only used for research purposes. The application of negative expiratory pressure (NEP) is a simple method to assess upper airway collapsibility that can be easily performed during wakefulness. We hypothesized that NEP will be, similarly to Pcrit, associated with upper airway anatomy assessed by computed tomography (CT) scan. METHODS: Patients under investigation for OSA underwent polysomnography, CT of the upper airway, NEP while awake, and Pcrit during sleep. NEP was performed with -5 cm H2O in supine position using a nasal mask. Pcrit was measured during sleep induced by low doses of midazolam. RESULTS: Twenty-eight male subjects were studied (age 45 ± 13 y, body mass index 29.4 ± 4.9 kg/m2, apnea-hypopnea index (AHI) 30 ± 26, range 2 to 86 events/h). NEP and Pcrit were similarly associated with tongue area (r = 0.646 and r = 0.585), tongue volume (r = 0.565 and r = 0.613) and pharyngeal length (r = 0.580 and r = 0.611), respectively (p < 0.05 for all comparisons). NEP and Pcrit were also significantly correlated with AHI (r = 0.490 and r = 0.531). NEP and Pcrit were significantly higher in patients with severe OSA than the remaining population. CONCLUSIONS: NEP is a simple and promising method that is associated with the anatomical component of upper airway collapsibility. NEP may be valuable to select patients for noncontinuous positive airway pressure alternative therapies for OSA.

Immediate effect of basic body awareness therapy on heart rate variability.

OBJECTIVE: To determine the immediate effect of a Basic Body Awareness Therapy (BAT) session on measures of heart rate variability (HRV) in healthy young people. METHODS: 13 healthy young subjects of both genders, who showed no illnesses related to the autonomic nervous system (ANS) underwent an ANS evaluation before and after conducting a session of BAT. The assessment of ANS activity was conducted through the HR with the aid of Nerve-Express(®) software. The BAT session lasted for 50 min and was performed by one investigator (blinded to the assessment procedures). RESULTS: After BAT session significant improvement was found in the sympathetic and parasympathetic modulation (p < 0.05), and the general estimate of heart rate variability (p < 0.04). CONCLUSION: BAT was found to be an effective, easy to apply and inexpensive therapeutic technique, able to change ANS in order to improve HR which may suggest better health conditions for participating individuals.

Effects of Neuromuscular Electrical Stimulation on the Masticatory Muscles and Physiologic Sleep Variables in Adults with Cerebral Palsy: A Novel Therapeutic Approach.

Cerebral palsy (CP) is a term employed to define a group of non-progressive neuromotor disorders caused by damage to the immature or developing brain, with consequent limitations regarding movement and posture. CP may impair orapharygeal muscle tone, leading to a compromised chewing function and to sleep disorders (such as obstructive sleep apnea). Thirteen adults with CP underwent bilateral masseter and temporalis neuromuscular electrical stimulation (NMES) therapy. The effects on the masticatory muscles and sleep variables were evaluated using electromyography (EMG) and polysomnography (PSG), respectively, prior and after 2 months of NMES. EMG consisted of 3 tests in different positions: rest, mouth opening and maximum clenching effort (MCE). EMG values in the rest position were 100% higher than values recorded prior to therapy for all muscles analyzed (p < 0.05); mean mouth opening increased from 38.0 ± 8.0 to 44.0 ± 10.0 cm (p = 0.03). A significant difference in MCE was found only for the right masseter. PSG revealed an improved in the AHI from 7.2±7.0/h to 2.3±1.5/h (p < 0.05); total sleep time improved from 185 min to 250 min (p = 0.04) and minimun SaO2 improved from 83.6 ± 3.0 to 86.4 ± 4.0 (p = 0.04). NMES performed over a two-month period led to improvements in the electrical activity of the masticatory muscles at rest, mouth opening, isometric contraction and sleep variables, including the elimination of obstructive sleep apnea events in patients with CP. Trial registration: ReBEC RBR994XFS http://www.ensaiosclinicos.gov.br.

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

BACKGROUND: Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin. METHODS/DESIGN: A randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay. DISCUSSION: This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.

Phototherapy with combination of super-pulsed laser and light-emitting diodes is beneficial in improvement of muscular performance (strength and muscular endurance), dyspnea, and fatigue sensation in patients with chronic obstructive pulmonary disease.

Phototherapy is an electrophysical intervention being considered for the retardation of peripheral muscular fatigue usually observed in chronic obstructive pulmonary disease (COPD). The objective of this study was to evaluate the acute effects of combination of super-pulsed laser and light-emitting diodes phototherapy on isokinetic performance in patients with COPD. Thirteen patients performed muscular endurance tests in an isokinetic dynamometer. The maximum voluntary isometric contraction (MVIC), peak torque (PT), and total work (TW) of the non-dominant lower limb were measured in two visits. The application of phototherapy or placebo (PL) was conducted randomly in six locations of femoral quadriceps muscle by using a cluster of 12 diodes (4 of 905 nm super-pulsed lasers, 0.3125 mW each; 4 of 875 nm LEDs, 17.5 mW each; and 4 of 640 nm LEDs, 15 mW each, manufactured by Multi Radiance Medical™). We found statistically significant increases for PT (174.7 ± 35.7 N · m vs. 155.8 ± 23.3 N · m, p = 0.003) and TW after application of phototherapy when compared to placebo (778.0 ± 221.1 J vs. 696.3 ± 146.8 J, p = 0.005). Significant differences were also found for MVIC (104.8 ± 26.0 N · m vs. 87.2 ± 24.0 N · m, p = 0.000), sensation of dyspnea (1 [0-4] vs. 3 [0-6], p = 0.003), and fatigue in the lower limbs (2 [0-5] vs. 5 [0.5-9], p = 0.002) in favor of phototherapy. We conclude that the combination of super-pulsed lasers and LEDs administered to the femoral quadriceps muscle of patients with COPD increased the PT by 20.2% and the TW by 12%. Phototherapy with a combination of super-pulsed lasers and LEDs prior to exercise also led to decreased sensation of dyspnea and fatigue in the lower limbs in patients with COPD.

Low level laser therapy reduces acute lung inflammation in a model of pulmonary and extrapulmonary LPS-induced ARDS.

The present study aimed to investigate the effects low level laser therapy (LLLT) in a LPS-induced pulmonary and extrapulmonary acute respiratory distress syndrome (ARDS) in BALB/c mice. Laser (830nm laser, 9J/cm(2), 35mW, 80s per point, 3 points per application) was applied in direct contact with skin, 1h after LPS administration. Mice were distributed in control (n=6; PBS), ARDS IT (n=7; LPS orotracheally 10µg/mouse), ARDS IP (n=7; LPS intra-peritoneally 100µg/mouse), ARDS IT+Laser (n=9; LPS intra-tracheally 10µg/mouse), ARDS IP+Laser (n=9; LPS intra-peritoneally 100µg/mouse). Twenty-four hours after last LPS administration, mice were studied for pulmonary inflammation by total and differential cell count in bronchoalveolar lavage (BAL), cytokines (IL-1beta, IL-6, KC and TNF-alpha) levels in BAL fluid and also by quantitative analysis of neutrophils number in the lung parenchyma. LLLT significantly reduced pulmonary and extrapulmonary inflammation in LPS-induced ARDS, as demonstrated by reduced number of total cells (p<0.001) and neutrophils (p<0.001) in BAL, reduced levels of IL-1beta, IL-6, KC and TNF-alpha in BAL fluid and in serum (p<0.001), as well as the number of neutrophils in lung parenchyma (p<0.001). LLLT is effective to reduce pulmonary inflammation in both pulmonary and extrapulmonary model of LPS-induced ARDS.

Effect of a hyperbolide mastication apparatus for the treatment of severe sleep bruxism in a child with cerebral palsy: long-term follow-up.

PURPOSE: Sleep bruxism is common among the various oromotor alterations found in individuals with cerebral palsy (CP). Few studies have investigated the use of the mastication device denominated "hyperbola" (HB) and none was found describing the use of such a device for the treatment of bruxism in children with CP. The aim of the present study was to evaluate the effect of the HB on electromyographic (EMG) activity in the jaw-closing muscles and the reduction in sleep bruxism in a child with CP using surface EMG analysis before and after nine months of treatment. METHODS: A seven-year-old boy with severe spastic CP and sleep bruxism was enrolled in this study. The HB was chosen as the treatment option for sleep bruxism in this case because the child did not accept an occlusal splint. The HB has a hyperbolic shape and is made of soft, non-toxic, odorless, tasteless silicone. There are five different sizes of HB manufactured based on the diversity of tooth sizes. This device produces proprioceptive excitation in the dentoalveolar nerve, spindles and Golgi tendon organs. HB has been employed for the treatment of temporomandibular disorder, abnormal oro-dental development, abnormal occlusion, xerostomy, halitosis and bruxism. HB therapy was performed for 5 min six times a day over a nine-week period. Surface EMG of the mandible at rest and during maximum contraction was performed on the masseter and temporalis muscles bilaterally to evaluate electromyographic activity before and after nine months of HB usage. RESULTS: HB usage led to a visible tendency toward the reorganization of mastication dynamics, achieving a marked balance in electromyographic activity of the jaw-closing muscles and improving the child's quality of life. CONCLUSION: Based on the findings of the present study, this noninvasive therapy may be useful for individuals with cerebral palsy due to its positive effects and low cost, which allows its use in the public health realm. Further clinical studies with a larger sample size are needed to validate these results and allow the development of a new treatment protocol for patients with spastic cerebral palsy.

Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial.

BACKGROUND: The project proposes three innovative intervention techniques (treadmill training, mobility training with virtual reality and transcranial direct current stimulation that can be safely administered to children with cerebral palsy. The combination of transcranial stimulation and physical therapy resources will provide the training of a specific task with multiple rhythmic repetitions of the phases of the gait cycle, providing rich sensory stimuli with a modified excitability threshold of the primary motor cortex to enhance local synaptic efficacy and potentiate motor learning. METHODS/DESIGN: A prospective, double-blind, randomized, controlled, analytical, clinical trial will be carried out.Eligible participants will be children with cerebral palsy classified on levels I, II and III of the Gross Motor Function Classification System between four and ten years of age. The participants will be randomly allocated to four groups: 1) gait training on a treadmill with placebo transcranial stimulation; 2) gait training on a treadmill with active transcranial stimulation; 3) mobility training with virtual reality and placebo transcranial stimulation; 4) mobility training with virtual reality and active transcranial stimulation. Transcranial direct current stimulation will be applied with the anodal electrode positioned in the region of the dominant hemisphere over C3, corresponding to the primary motor cortex, and the cathode positioned in the supraorbital region contralateral to the anode. A 1 mA current will be applied for 20 minutes. Treadmill training and mobility training with virtual reality will be performed in 30-minute sessions five times a week for two weeks (total of 10 sessions). Evaluations will be performed on four occasions: one week prior to the intervention; one week following the intervention; one month after the end of the intervention;and 3 months after the end of the intervention. The evaluations will involve three-dimensional gait analysis, analysis of cortex excitability (motor threshold and motor evoked potential), Six-Minute Walk Test, Timed Up-and-Go Test, Pediatric Evaluation Disability Inventory, Gross Motor Function Measure, Berg Balance Scale, stabilometry, maximum respiratory pressure and an effort test. DISCUSSION: This paper offers a detailed description of a prospective, double-blind, randomized, controlled, analytical, clinical trial aimed at demonstrating the effect combining transcranial stimulation with treadmill and mobility training on functionality and primary cortex excitability in children with Cerebral Palsy classified on Gross Motor Function Classification System levels I, II and III. The results will be published and will contribute to evidence regarding the use of treadmill training on this population. TRIAL REGISTRATION: ReBEC RBR-9B5DH7.

Effect of an occlusal splint on sleep bruxism in children in a pilot study with a short-term follow up.

The aim of the present study was to evaluate the effect of the use of an occlusal splint in children with bruxism in a pilot study with a short-term follow up. Seventeen children were recruited, only nine of whom formed the sample following the application of the inclusion criteria: presence of sleep bruxism for at least six months (based on parents' reports); presence of at least the first permanent molars; and no previous history of treatment involving an occlusal splint. The sample was submitted to a clinical exam. Other sleep problems were screened with the use of a sleep questionnaire filled out by parents before and after 90 days of occlusal splint usage. The children received a flat acrylic resin splint with full coverage of the occlusal surfaces to be worn in the maxilla. In children with erupting teeth, a space was created in the splint to allow normal eruption. After the 90-day period, the absence of sleep bruxism and sleep movements was noted in most of children. Moreover, snoring was reduced in nearly 50%, which raises a new issue to be investigated with regard to the pathophysiology of sleep bruxism. The use of an occlusal splint was effective in reducing the symptoms of sleep bruxism and other sleep problems. Further investigations should be carried out on the relationship between snoring and sleep bruxism in children.

Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial.

BACKGROUND: Low-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep. METHODS/DESIGN: One hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤ .05). TRIAL REGISTRATION: The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-42gkzt).

Effects of neuromuscular electrical stimulation, laser therapy and LED therapy on the masticatory system and the impact on sleep variables in cerebral palsy patients: a randomized, five arms clinical trial.

BACKGROUND: Few studies demonstrate effectiveness of therapies for oral rehabilitation of patients with cerebral palsy (CP), given the difficulties in chewing, swallowing and speech, besides the intellectual, sensory and social limitations. Due to upper airway obstruction, they are also vulnerable to sleep disorders. This study aims to assess the sleep variables, through polysomnography, and masticatory dynamics, using electromiography, before and after neuromuscular electrical stimulation, associated or not with low power laser (Gallium Arsenide- Aluminun, =780 nm) and LED (= 660 nm) irradiation in CP patients. METHODS/DESIGN: 50 patients with CP, both gender, aged between 19 and 60 years will be enrolled in this study. The inclusion criteria are: voluntary participation, patient with hemiparesis, quadriparesis or diparetic CP, with ability to understand and respond to verbal commands. The exclusion criteria are: patients undergoing/underwent orthodontic, functional maxillary orthopedic or botulinum toxin treatment. Polysomnographic and surface electromyographic exams on masseter, temporalis and suprahyoid will be carry out in all sample. Questionnaire assessing oral characteristics will be applied. The sample will be divided into 5 treatment groups: Group 1: neuromuscular electrical stimulation; Group 2: laser therapy; Group 3: LED therapy; Group 4: neuromuscular electrical stimulation and laser therapy and Group 5: neuromuscular electrical stimulation and LED therapy. All patients will be treated during 8 consecutive weeks. After treatment, polysomnographic and electromiographic exams will be collected again. DISCUSSION: This paper describes a five arm clinical trial assessing the examination of sleep quality and masticatory function in patients with CP under non-invasive therapies. TRIAL REGISTRATION: The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC RBR-994XFS.

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: study protocol for prospective, randomized, controlled trial.

BACKGROUND: The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. METHODS/DESIGN: Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. DISCUSSION: The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results. TRIAL REGISTRATION: RBR5qzs8h.

Electromyographic analysis of masseter and anterior temporalis muscle in sleep bruxers after occlusal splint wearing.

Bruxism is widely defined as an anxiety response to environmental stress. Occlusal splints are frequently used in sleep bruxism, to protect teeth from damage resulting from the contraction force of mandibular muscles, or to reduce the orofacial pain by relaxing masticatory muscles. Surface electromyography (EMG) of the right and left masseter and temporalis muscles was performed in 15 women presenting sleep bruxism and temporomandibular disorders related to occupational stress, after nocturnal use of the occlusal splint. The EMG signals were recorded twice per patient: After a work shift (pre-splint) and after a night of sleep with the occlusal splint (post-splint) before a new workday. The parametric t-paired test was used to compare differences of the RMS amplitude between pre and post-splint records, for resting and maximal clenching effort. The level of significance for each comparison was set to p < 0.05. The results of the study supports the premise that the use of occlusal splint reduces EMG activity in the masseter and anterior temporalis muscles, in patients who presented with sleep bruxism related to occupational stress.

Evaluation of the osteogenic effect of low-level laser therapy (808 nm and 660 nm) on bone defects induced in the femurs of female rats submitted to ovariectomy.

The present study aimed to evaluate the effects of LLLT (660- and 808-nm wavelengths) on the process of repairing bone defects induced in the femurs of female rats submitted to ovariectomy. Bilateral ovariectomies were performed on 18 female Wistar rats, which were divided into control and irradiated groups after the digital analysis of bone density showed decreased bone mass and after standardized drilling of the femurs. The irradiated groups received 133 J/cm(2) of AsGaAl (660-nm) and InGaAlP (880-nm) laser radiation. The animals were euthanized on days 14 and 21 after the bone defects were established. Detailed descriptive histological evaluations were performed, followed by semi-quantitative histomorphometry. The results from days 14 and 21 showed that the irradiated groups presented increased density of osteoblasts, fibroblasts, and immature osteocytes on the tissue surface compared with the control (non-irradiated) groups (p < 0.05). Additionally, inflammatory infiltrate evaluations showed that LLLT decreased the accumulation of leukocytes when compared to the control treatment (p < 0.05). We concluded that, in our experimental model, both wavelengths (660-nm and 880-nm) inhibited the inflammatory process and induced the proliferation of cells responsible for bone remodeling and repair.