Dataset Information

Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study.

ABSTRACT:

Introduction

Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the neural tube. This condition drastically affects the structures of the spinal cord resulting in deficiencies. The combination of these deficiencies results in an overall decrease in mobility and functional participation amongst this population. Physiotherapy plays an essential role in rehabilitating people with MMC. The current literature shows that resources such as photobiomodulation (PBM) may support the rehabilitation of neurological conditions. The aim of the proposed study is to evaluate the effects of photobiomodulation (PBM) combined with physical therapy on functional performance in children with low lumbosacral myelomeningocele.

Materials and methods

This is a protocol randomized clinical blind study, that will include 30 individuals of both sexes, aged between 5 to 8 years, diagnosed with low and sacral lumbar myelomeningocele and capable of performing the sit-to-stand task. The participants will be randomly assigned into two treatment groups: PBM + physiotherapeutic exercises and sham PBM + physiotherapeutic exercises. Irradiation will be carried out with light emitting diode (LED) at a wavelength of 850 nm, energy of 25 J per point, 50 seconds per point and a power of 200 mW. The same device will be used in the placebo group but will not emit light. Muscle activity will be assessed using a portable electromyograph (BTS Engineering) and the sit-to-stand task will be performed as a measure of functioning. Electrodes will be positioned on the lateral gastrocnemius, tibialis anterior and rectus femoris muscles. The Pediatric Evaluation of Disability Inventory will be used to assess functional independence. Quality of life will be assessed using the Child Health Questionnaire-Parent Form 50. Changes in participation will be assessed using the Participation and Environment Measure for Children and Youth. The data will be analyzed with the aid of GraphPad PRISM.

Discussion

The results of this study can contribute to a better understanding of the effectiveness of PBM on functioning and quality of life in children with myelomeningocele.

Clinical trial registration

ClinicalTrials.gov Identifier: NCT04425330.

SUBMITTER: Silva T

PROVIDER: S-EPMC8494316 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study.

Silva Tamiris T Queiroz Juliana Roque de JR Turcio Karina Helga Leal KHL Tobelem Daysi da Cruz DDC Araújo Tamires Ribeiro TR Coutinho Kevelin Siqueira Lira KSL Chavantes Maria Cristina MC Horliana Anna Carolina Ratto Tempestini ACRT Deana Alessandro Melo AM Silva Daniela de Fátima Teixeira da DFTD Castelo Paula Midori PM Fernandes Kristianne Porta Santos KPS Motta Lara Jansiski LJ Mesquita-Ferrari Raquel Agnelli RA Kalil Bussadori Sandra S

PloS one 20211006 10

<h4>Introduction</h4>Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the neural tube. This condition drastically affects the structures of the spinal cord resulting in deficiencies. The combination of these deficiencies results in an overall decrease in mobility and functional participation amongst this population. Physiotherapy plays an essential role in rehabilitating people with MMC. The current literature shows that resources such as photobiomodulation ( ...[more]

PMID: 34613973

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Project description:IntroductionGenitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM.ObjectiveThe goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region.MethodIn this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one.Trial registrationThis protocol is registered at ClinicalTrials.gov under the number NCT05557799.

Project description:ImportanceThe Management of Myelomeningocele Study (MOMS), a randomized clinical trial of prenatal vs standard postnatal repair for myelomeningocele, found that prenatal repair reduced hydrocephalus and hindbrain herniation and improved motor function in children aged 12 to 30 months. The Management of Myelomeningocele Study Follow-up (MOMS2) was conducted in children at ages 5 to 10 years. The primary (neurocognitive) outcome has already been reported.ObjectiveTo determine whether MOMS2 participants who had prenatal repair have better physical functioning than those with postnatal repair.Design, setting, and participantsParticipants from MOMS were recruited for participation in the follow-up study, MOMS2, conducted from April 9, 2012, to April 15, 2017. For this secondary analysis of the randomized clinical trial, trained examiners without knowledge of the treatment group evaluated the physical characteristics, self-care skills, neurologic function, and mobility of the children. Physical functioning outcomes were compared between the prenatal and postnatal repair groups. MOMS2 was conducted at the same 3 clinical sites as MOMS. Home visits were conducted for families who were unable to travel to one of the clinical sites. Of the 161 children with myelomeningocele aged 5 to 10 years old enrolled in MOMS2, 154 had a physical examination and were included in the analyses.ExposuresPrenatal repair of myelomeningocele.Main outcomes and measuresPrespecified secondary trial outcomes of self-care skills, functional mobility, walking skills, and motor level.ResultsThis analysis included 78 children with postnatal repair (mean [SD] age, 7.4 [2.1] years; 50 girls [64.1%]; 69 White children [88.5%]) and 76 with prenatal repair (mean [SD] age, 7.5 [1.2] years; 43 boys [56.6%]; 70 White children [92.1%]). Children in the prenatal repair group were more competent with self-care skills (mean [SD] percentage of maximum FRESNO Scale score, 90.8% [9.6%] vs 85.5% [17.6%]) and were commonly community ambulators per the Modified Hoffer Classification (51.3% prenatal vs 23.1% postnatal; adjusted relative risk [aRR] for sex, 1.70; 95% CI, 1.23-2.34). Children with prenatal repair also performed the 10-m walk test 1 second faster (difference in medians, 1.0; 95% CI, 0.3-1.7), had better gait quality (adjusted mean difference for home distances of 5 m, 1.71; 95% CI, 1.14-2.54), and could perform higher-level mobility skills (adjusted mean difference for motor total, 5.70; 95% CI, 1.97-11.18). Children in the prenatal repair group were less likely to have a motor function level worse than their anatomic lesion level (aRR, 0.44; 95% CI, 0.25-0.77).Conclusions and relevanceThis secondary analysis of a randomized clinical trial found that the physical functioning benefits of prenatal repair for myelomeningocele reported at age 30 months persisted into school age. These findings indicate the benefit of prenatal repair of myelomeningocele for school-aged children.Trial registrationClinicalTrials.gov Identifier: NCT00060606.

Project description:BackgroundPhotobiomodulation, specifically high-energy photobiomodulation therapy (H-PBMT), is gaining recognition as a promising non-invasive intervention for managing knee osteoarthritis (KOA). While H-PBMT has demonstrated effectiveness in reducing pain and improving physical function, most evidence to date focuses on short-term symptomatic relief. The potential for H-PBMT to offer sustained benefits and modify the underlying progression of KOA remains insufficiently explored, warranting further investigation.ObjectiveThis study aims to assess the short-term and sustained effects of H-PBMT combined with rehabilitation exercises in patients with mild to moderate KOA, focusing on knee radiographic morphological changes over a 3-month follow-up period.MethodsThis protocol outlines a parallel-group, randomized, double-blind, placebo-controlled trial. Fifty participants with mild to moderate KOA (based on the Kellgren-Lawrence classification) will be randomly assigned to either the active H-PBMT plus exercise group (H-PBMT+E, n = 25) or the placebo photobiomodulation plus exercise group (PL+E, n = 25). Both groups will undergo an 8-week intervention, consisting of conventional rehabilitation exercises paired with either active or placebo photobiomodulation. H-PBMT will be delivered using the BTL-6000 HIL device with a 1064 nm wavelength, providing a total energy dose of 3190 J per 15-minute session. The treatment protocol includes both pulse mode (25 Hz, 5 W, 190 J) for analgesia and continuous mode (5 W, 3000 J) for biostimulation. Participants will be blinded to their group allocation through the use of a placebo device that mimics the active treatment without emitting therapeutic energy. Additionally, the outcome assessors will be blinded to the group allocations to ensure unbiased evaluation of the trial outcomes. The primary outcome is the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes include the Timed Up-and-Go test, Numerical Pain Rating Scale, and knee X-rays. Outcomes will be evaluated at baseline, immediately post-intervention (week 8), and at 3-month follow-up (week 20). Data will be analyzed according to the intention-to-treat principle, with a two-way repeated measures ANOVA used to assess time, group, and interaction effects.ConclusionThis study is expected to provide valuable insights into the sustained effects and potential disease-modifying properties of combining H-PBMT with rehabilitation exercises in managing KOA. The findings could inform more effective treatment protocols, improving rehabilitation outcomes and patient quality of life.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12624000699561p).

Project description:The ergogenic effects of photobiomodulation therapy combined with a static magnetic field (PBMT-sMF) on exercises with characteristics similar to those of CrossFit® are unknown. This study was aimed at investigating the effects of PBMT-sMF applied at different times on recovery and physical performance in CrossFit® athletes by analyzing functional aspects, muscle damage, inflammatory processes, and oxidative stress. This was a prospectively registered, triple-blinded, placebo-controlled, crossover trial. CrossFit® athletes were recruited and assigned to receive one of the four possible interventions. Each intervention included protocols before and after the exercise (referred to as the workout of the day (WOD)). The four possibilities of intervention were as follows: placebo before and after WOD (placebo), PBMT-sMF before and placebo after WOD (PBMT-sMF before), placebo before and PBMT-sMF after WOD (PBMT-sMF after), and PBMT-sMF before and after WOD (PBMT-sMF before and after). The order of possibilities for the interventions was randomized. The primary outcome was the functional test performance. The secondary outcomes were the subjective perception of exertion, muscle damage, inflammation, and oxidative stress. The outcomes were measured before the WOD; immediately after the intervention; and 1, 24, and 48 hours after the WOD. Statistical analysis was performed using repeated measures ANOVA followed by the Bonferroni post hoc test to examine the differences between the interventions at each time point. Twelve participants were randomized and analyzed for each sequence. PBMT-sMF enhanced the performance on functional tests (calculated as a percentage of change) when applied before or after WOD in the assessment performed immediately post-WOD and at 24 and 48 hours later (p < 0.05) compared to placebo and PBMT-sMF before and after WOD. In terms of the secondary outcomes, PBMT-sMF applied before or after WOD significantly decreased the creatine kinase, catalase, and superoxide dismutase activities and interleukin-6, thiobarbituric acid, and carbonylated protein levels (all p < 0.05) compared to the other possibilities of intervention. In addition, PBMT-sMF applied before and after WOD decreased creatine kinase activity at 24 hours and IL-6 levels at 24 and 48 hours compared to placebo (p < 0.05). None of the participants reported any adverse events. PBMT-sMF enhanced the performance of functional tests, decreased the levels of biochemical markers of muscle damage and inflammation, decreased oxidative stress, and increased antioxidant activity in CrossFit® athletes when applied before or after WOD.

Project description:IntroductionLoss of a dental element can generate several repercussions in the stomatognathic system. According to the latest survey by the Ministry of Health, in 2010, Brazilian adults had, on average, 7 missing teeth. This loss may lead to movement of the adjacent teeth and the antagonist, which would make prosthetic rehabilitation harder to do. Anchoring systems, such as mini-implants, have been increasingly used as a treatment option because they act with heavy but controlled forces and without side effects. Recent studies have shown that photobiomodulation (PBM) can accelerate orthodontic movement in molar intrusion. The objective of this study will be to evaluate the effect of PBM on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues. PATIENT CONCERNS:: the concerns assessments will be done over the study using anamnesis interviews and specific questionnaire.Diagnosisverticalization will be evaluated by clinical and radiographic analysis.InterventionsThirty four healthy patients aged 30 to 60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 808 nm, 100 mW, receiving 1J per point, 10 seconds, 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J/cm. The orthodontic forces of verticalization (corresponding to any exchange of elastomeric ligation) will be applied every 30 days and the PBM will be applied immediately, 3 and 7 days of each month, for a period of 3 months. The crevicular gingival fluid (CGF) will be collected on the 1st, 3rd, and 7th days after the first activation, and then on the 3rd day of the following 2 months.OutcomesInterleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA. Panoramic radiography will be performed at baseline and 90 afterwards to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analog Scale (VAS) will be used in all the consultations, and to evaluate the quality of life, the Oral Health Impact Profile (OHIP-14) questionnaire will be applied. Analgesics will be given and the quantity of drugs will be counted. If the data are normal, they will be submitted to Student t test. The data will be presented as means ± SD and the value of p will be defined as <0.05.DiscussionThis protocol will determine the effectiveness of photobiomoduation regarding the orthodontic movement of molar verticalization.Ethics and disseminationThis protocol received approval from the Human Research Ethics Committee of Universidade Nove de Julho (certificate number: 3 533 219). The data will be published in a peer-reviewed periodical.

Dataset Information

Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study.

Introduction

Materials and methods

Discussion

Clinical trial registration

Publications

Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study.

Similar Datasets

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