A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions.

Background: Randomized controlled trials using complete healing as an endpoint suffer from poor statistical power, owing to the heterogeneity of wounds and their healing trajectories. The Food and Drug Administration (FDA) has recently consulted with expert groups to consider percentage area reduction (PAR) of the wound over a 4-week period as a valid intermediate endpoint, creating the opportunity for more powerful study designs. Methods: A within-subject controlled study design comparing the PAR of venous leg ulcers (VLU) in patients over 4 weeks receiving different interventions. Twenty-nine patients received multilayer compression over 4 weeks, followed by neuromuscular electrostimulation (NMES) of the leg muscle pump in addition to compression for a further 4 weeks. Paired comparison was then made of PAR between the two phases. A second cohort of 22 patients received only multilayer compression throughout both 4-week phases. Results: Patients randomized to NMES saw a significant increase in healing rate compared with compression alone, whereas patients receiving compression only saw no significant change in healing rate throughout the course of the study. Conclusions: Intermittent NMES of the common peroneal nerve significantly accelerates the healing of VLU. It is well tolerated by patients and deserves serious consideration as an adjuvant to compression therapy. PAR is a useful metric for comparing the performance of wound healing interventions, and the self-controlled trial design allows sensitive discrimination with a relatively small number of subjects over a reasonably short trial period. The study is reported according to the CONSORT reporting guidelines. Clinical Trial Registration: NCT03396731 (ClinicalTrials.gov).

Neuromuscular Electrical Stimulation in Facial Aging: an Integrative Literature Review / Estimulación Eléctrica Neuromuscular en el Envejecimiento Facial: Revisión Integradora della Literatura / Estimulação Elétrica Neuromuscular no Envelhecimento Facial: uma Revisão Integrativa da Literatura

ABSTRACT Despite of being a natural physiological process, aging is considered a degenerative process with evident effects on aging skin, such as reduced elasticity, wrinkles, reduced facial fat and muscle tone, sagging, changes in facial contour, and sarcopenia on the face. These changes can generate social stigma, suffering, and psychological discomfort for the patient. Thus, this study aimed to evaluate the effectiveness of Neuromuscular Electrical Stimulation (NMES), a technique used in physical therapy for muscle training, in attenuating the signs of facial aging. For this purpose, a scientific survey of publications indexed on the Medline (PubMed), CINAHL, Embase, PEDro, Lilacs, ERIC, Scopus, Web of Science, and Google Scholar databases was conducted and, based on pre-established criteria, two relevant publications for the topic were selected for discussion. The scientific literature regarding the use of NMES to attenuate the signs of aging is still very scarce. The survey showed the need to discuss the current state of knowledge. Our results suggest that, theoretically, NMES could be a promising method to attenuate the signs of aging; however, there are still no conclusive results regarding the clinical effectiveness of using NMES in the facial muscles since few studies relate NMES to facial rejuvenation. More studies are needed, with greater methodological rigor and low level of bias, using precise techniques in the evaluation and allowing to interpret with greater scientific commitment of the physiological mechanism of the muscular stimulus and its interrelation with the integumentary system, proving its effectiveness in the improvement of skin appearance.

RESUMEN El envejecimiento es un proceso fisiológico natural, aunque se considera un proceso degenerativo. Sus efectos son evidentes en la piel envejecida, que presenta disminución de la elasticidad, grasa y tono muscular, así como arrugas, flacidez, cambios de contorno y sarcopenia. Estos cambios pueden generar un estigma social y malestar psicológico para el portador. En ese contexto, el objetivo de este estudio fue evaluar la efectividad del uso de la estimulación eléctrica neuromuscular (NMES), una técnica utilizada en Fisioterapia de entrenamiento muscular para atenuar los signos del envejecimiento facial. Para ello, se realizó un relevamiento de las publicaciones indexadas en las plataformas MEDLINE (PubMed), CINAHL, Embase, PEDro, LILACS, ERIC, Scopus, Web of Science y Google Scholar, y, con base en criterios preestablecidos, se seleccionaron dos publicaciones relevantes sobre el tema. La literatura científica sobre el uso de NMES en la atenuación de los signos del envejecimiento es aún escasa. La búsqueda reveló la necesidad de una discusión sobre el estado actual del conocimiento. Los resultados de esta revisión sugieren que la NMES puede ser un método prometedor de entrenamiento muscular cuando se aplica para atenuar los signos del envejecimiento. Sin embargo, todavía hay poca evidencia con respecto a la efectividad de NMES en los músculos faciales, ya que pocos estudios relacionan NMES con el rejuvenecimiento facial. Son necesarios estudios con mayor rigor metodológico para minimizar sesgos y el uso de técnicas de evaluación precisas, que permitan dilucidar el mecanismo fisiológico del estímulo muscular y su interrelación con el sistema tegumentario y que permitan probar la eficacia de la NMES en la mejora del aspecto de la piel del rostro.

RESUMO Embora seja um processo fisiológico natural, o envelhecimento é considerado degenerativo. Seus efeitos são evidentes na pele envelhecida, que apresenta redução de elasticidade, gordura e tônus muscular, assim como rugas, flacidez, alteração de contornos e sarcopenia. Tais mudanças podem gerar um estigma social e desconforto psicológico para o seu portador. Nesse contexto, objetivou-se avaliar a eficácia do uso da estimulação elétrica neuromuscular (EENM), uma técnica utilizada na Fisioterapia para o treinamento muscular, visando à atenuação dos sinais do envelhecimento facial. Para isso, foi realizado um levantamento de publicações indexadas nas plataformas MEDLINE (PubMed), CINAHL, Embase, PEDro, LILACS, ERIC, Scopus, Web of Science e Google Scholar e, a partir de critérios preestabelecidos, foram selecionadas duas publicações relevantes sobre o tema. A literatura científica sobre o uso da EENM na atenuação dos sinais do envelhecimento ainda é escassa. O levantamento revelou a necessidade de uma discussão a respeito do estado atual do conhecimento. Os resultados desta revisão sugerem que a EENM pode ser um método promissor de treinamento muscular quando aplicado à atenuação dos sinais de envelhecimento. Contudo, ainda há poucas evidências quanto à eficácia da EENM na musculatura da face, visto que poucos estudos relacionam a EENM ao rejuvenescimento facial. São necessários estudos com maior rigor metodológico, a fim de minimizar vieses, e utilização de técnicas precisas de avaliação, permitindo a elucidação do mecanismo fisiológico do estímulo muscular e sua inter-relação com o sistema tegumentar e possibilitando a comprovação da eficácia da EENM na melhoria da aparência da pele facial.

Effectiveness of neuromuscular electrostimulation in COPD subjects on mechanical ventilation. A systematic review and meta-analysis.

OBJECTIVE: To estimate the effectiveness of Neuromuscular Electrostimulation (NMES) in adults with COPD undergoing MV. METHOD: A sensitive search was performed in MEDLINE, Embase, CENTRAL, CINAHL and other resources. Randomized Controlled Clinical Trials (RCTs) or non-RCTs that enrolled adults with COPD on MV due to an exacerbation of their disease were included. Two independent reviewers screened, extracted information, and assessed the risk of bias (RoB 2 tool) and the certainty of evidence (GRADE approach) from the included studies. RESULTS: Four RCTs (144 participants) were included. Subjects who underwent NMES were able to move from bed to chair independently in less time (MD = 4.98 days less; 95% CI -8.55 to -1.47; 2 RCTs; low certainty of the evidence) and they were fewer days on MV (MD = 2.89 days less; 95% CI -4.58 to -1.21); 3 RCTs; low certainty of the evidence) than the control group. However, the effect of NMES on muscle strength is unclear (very low certainty of the evidence). CONCLUSIONS: NMES may improve functional independence and decrease MV time in adults with COPD; however, its effectiveness on muscle strength is uncertain. More and better RCTs are needed to determine with greater certainty the effectiveness of NMES in this population.

La electroestimulación neuromuscular como mecanismo complementario en el entrenamiento deportivo de predominancia anaeróbica / Neuromuscular electro-stimulation as a complementary mechanism in sports training of anaerobic predominance

Introducción: La electroestimulación neuromuscular puede dar un valor agregado a los programas de ejercicio físico de rehabilitación, siempre y cuando se contemplen aspectos como los objetivos propios de cada persona, la tolerancia a la intensidad y las necesidades de recuperación y descanso. Así mismo, puede ser un elemento interesante a agregar en la planificación deportiva con miras a mejorar la recuperación, así como en el aumento del rendimiento físico. Objetivo: El objetivo principal de la presente investigación fue determinar los efectos del ejercicio combinado de electroestimulación neuromuscular y ejercicios de alta intensidad y corta duración en hombres sanos y físicamente activos sobre el índice de fatiga. Metodología: 34 hombres sanos, físicamente activos y estudiantes de educación física (19,4 ± 2,60 años) fueron aleatorizados y organizados en cuatro grupos: G1, programa de electroestimulación neuromuscular; G2, entrenamiento de alta intensidad y corta duración: G3, ejercicio combinado de alta intensidad y corta duración y, electroestimulación neuromuscular; y G4, grupo control. Se aplicó un test de Wingate antes y después del periodo de entrenamiento. Resultados: En el grupo G3 se evidencian aumentos en el rendimiento anaeróbico con diferencias significativas en la potencia promedio relativa al peso (p=0,027), con un aumento de 7,36% y con una disminución de 12,2% en el índice de fatiga (p=0,048). En el grupo G4 se evidencian disminuciones en el rendimiento, evidenciado a través de las diferencias significativas en la potencia media (p=0,030), con una disminución en el rendimiento de 6,32% y una disminución en el rendimiento en la potencia media relativa al peso con diferencia significativa (p=0,010) de 3,92%. Conclusiones: Un programa combinado de electroestimulación neuromuscular y ejercicio intervalico de alta intensidad mejora el rendimiento anaeróbico en la potencia media y relativa al peso, evidenciado a través de un test de Wingate. Así mismo, disminuye el porcentaje de caída del rendimiento anaeróbico, mostrando mejores resultados frente a un entrenamiento de solo ejercicio intervalico de alta intensidad

Introduction: Neuromuscular electrostimulation can add value to rehabilitation physical exercise programs, as long as aspects such as the objectives of each person, tolerance to intensity, and the needs for recovery and rest are considered. Likewise, it can be an interesting element to add in sports planning with a view to improving recovery, as well as increasing physical performance. Objective: The main objective of this research was to determine the effects of combined neuromuscular electrostimulation exercise and high intensity and short duration exercises in healthy and physically active men on the fatigue index. Methodology: 34 healthy, physically active, and physical education male students (19.4 ± 2.60 years) were randomized and organized into four groups: G1, neuromuscular electrostimulation program; G2, high intensity and short duration training; G3, combined exercise of high intensity and short duration, and neuromuscular electrostimulation; and G4, control group, A Wingate test was applied before and after the training period. Results: In the G3 group, there are increases in anaerobic performance with significant differences in the average power relative to weight (p=0.027), with an increase of 7.36%, and a decrease of 12.2% in the fatigue index (p=0.048). In the G4 group there are decreases in performance, evidenced through the significant differences in the average power (p = 0.030), with a decrease in performance of 6.32% and a decrease in the performance in mean power relative to weight with a significant difference (p=0.010) of 3.92%. Conclusions: A combined program of neuromuscular electrostimulation and high-intensity interval exercise improves anaerobic performance in mean power and relative to weight, evidenced through a Wingate test. Likewise, it decreases the percentage of drop in anaerobic performance, showing better results in comparison to training with only high-intensity interval training

Effectiveness of neuromuscular electrostimulation in COPD subjects on mechanical ventilation. A systematic review and meta-analysis

Abstract Objective: To estimate the effectiveness of Neuromuscular Electrostimulation (NMES) in adults with COPD undergoing MV. Method: A sensitive search was performed in MEDLINE, Embase, CENTRAL, CINAHL and other resources. Randomized Controlled Clinical Trials (RCTs) or non-RCTs that enrolled adults with COPD on MV due to an exacerbation of their disease were included. Two independent reviewers screened, extracted information, and assessed the risk of bias (RoB 2 tool) and the certainty of evidence (GRADE approach) from the included studies. Results: Four RCTs (144 participants) were included. Subjects who underwent NMES were able to move from bed to chair independently in less time (MD = 4.98 days less; 95% CI -8.55 to -1.47; 2 RCTs; low certainty of the evidence) and they were fewer days on MV (MD = 2.89 days less; 95% CI -4.58 to -1.21); 3 RCTs; low certainty of the evidence) than the control group. However, the effect of NMES on muscle strength is unclear (very low certainty of the evidence). Conclusions: NMES may improve functional independence and decrease MV time in adults with COPD; however, its effectiveness on muscle strength is uncertain. More and better RCTs are needed to determine with greater certainty the effectiveness of NMES in this population.

Spatial difference can occur between activated and damaged muscle areas following electrically-induced isometric contractions.

KEY POINTS: T2 mapping combined to image registration and statistical parametric mapping analysis is a suitable methodology to accurately localize and compare the extent of both activated and damaged muscle areas. Activated muscle areas following electrically-induced isometric contractions are superficial, but damaged regions are muscle specific and can be related to the muscle morphology and/or the relative spatial position within a muscle group leading to potential intramuscular muscle shear strain. Tissues other than active skeletal muscle fibres can be altered during unaccustomed neuromuscular electrical stimulation-induced isometric contractions. ABSTRACT: Skeletal muscle isometric contractions induced by neuromuscular electrical stimulation (NMES) exercise can generate damage within activated muscles. This study aimed at comparing the localization and the extent of NMES-activated muscle areas and induced damage regions using magnetic resonance imaging. Thirteen healthy subjects performed a single bout of NMES-induced isometric contractions known to induce a decrease in maximal voluntary isometric contraction (MVC) and increase in muscle volume and transverse relaxation time (T2 ). All the parameters were measured before, immediately after (POST), 7 days (D7), 14 days (D14) and 21 days (D21) after the NMES session. Spatial normalization of T2 maps were performed to compare the localization of muscle activation areas and damaged muscle regions from statistical mapping analyses. A significant decrease in MVC was found at POST (-26 ± 9%) and in delayed time at D7 (-20 ± 6%) and D14 (-12 ± 5%). Although muscle activation was statistically detected through T2 increase at POST in superficial parts of the two muscles located beneath the stimulation electrodes (i.e. vastus lateralis and vastus medialis), alterations quantified in a delayed time from increased T2 were mainly located in the deep muscle region of the vastus lateralis (+57 ± 24% of mean T2 ) and superficial area of the vastus medialis (+24 ± 16% of mean T2 ) at D7 and were still observed in whole muscle at D21. The discrepancy between activated and damaged areas in the vastus lateralis implies that tissues other than active skeletal muscle fibres were altered during unaccustomed NMES-induced isomeric contractions.

Neuromuscular electrostimulation on lower limb wounds.

The geko™ is a disposable neuromuscular electrostimulation (NMES) device intended to increase blood circulation and promote wound healing in a range of lower limb conditions. The purpose of this case series was to evaluate the therapeutic effect of the geko device on wound healing outcomes over an 8-week period. Thirty patients with non-healing wounds (≥ 12-week duration) of either venous leg ulceration (VLU), mixed leg ulceration (MLU) or diabetic foot ulceration aetiology were recruited from a local outpatient wound clinic in the South Wales area. Over the 8 weeks 2 participants (8%) achieved complete re-epithelialisation between baseline and endpoint. Mean wound surface area decreased (7.6 cm2) and there was an increase of 21% in the mean percentage of granulation tissue in the wound bed. Pain levels reduced in 52% of patients who completed the study, but the extent of oedema reduction was difficult to establish given that 76% of the cohort were treated with a form of compression as part of standard care. The findings support the use of the therapy in patients with painful VLUs and MLUs, but further research needs to be conducted to establish the generalisability of the findings to the wider population of patients living with chronic wounds of differing aetiology in the lower limb.

Does neuromuscular electrostimulation have the potential to increase intrinsic foot muscle strength?

PURPOSE: The purpose of this study was to investigate the effect of an eight-week neuromuscular electrostimulation program on the intrinsic foot muscle strength. The results were compared with those from a passive and an active control group. METHODS: 74 healthy participants were recruited and divided into three groups: a neuromuscular electrostimulation group (n=19), a passive control group (n=15) with no further intervention, and an active control group following a running protocol with minimal shoes (n=40). The electrostimulation and running groups followed a training protocol consisting of two sessions per week over a period of eight weeks. Three characteristics of intrinsic foot muscle strength were investigated: cross sectional area of the abductor hallucis muscle, longitudinal arch stability, and intrinsic foot muscle fatigue. RESULTS: After eight weeks of intervention, the cross sectional area increased by 16.3% for the running group with a large effect size (0.801) according to Cohen's d. The electrostimulation group showed no such effect. The increase in the cross sectional area had no impact on longitudinal arch stability or intrinsic foot muscle fatigue results. CONCLUSION: This study investigated neuromuscular electrostimulation as a prevention and rehabilitation strategy. The results indicate that, compared to minimally shod running, the effects of electrostimulation on healthy participants might be too small to be detected. Further, the results provide evidence that the static navicular drop test is not sensitive enough to indicate intrinsic foot muscle strength. This appears clinically relevant, as this test is often used by therapists to evaluate patients' longitudinal arch function.

Neuromuscular electrostimulation: a new therapeutic option to improve radio-cephalic arteriovenous fistula maturation in end-stage chronic kidney disease patients.

BACKGROUND: Radio-cephalic arteriovenous fistula (RCAVF) is the gold standard vascular access for end-stage chronic kidney disease patients. Exercises after arteriovenous fistula (AVF) creation improve maturation. No articles are published regarding neuromuscular electrostimulation (NMES) in AVF maturation. OBJECTIVES: To assess the usefulness of a NMES programme on RCAVF maturation process. METHODS: An 8-week single-centre prospective study. Two groups were established: control group (CG): underwent usual RCAVF forearm exercises and electrostimulation group (ESG): underwent RCAVF NMES programme. Handgrip (HG) measurement, preoperative Doppler ultrasonography (DUS) parameters, clinical and DUS maturation as well as surgical complications were assessed. RESULTS: Thirty-six patients (54% men). Mean age 67.9 ± 14.3 years; 12 ESG and 24 CG. Demographic data, comorbidities, medical treatment, HG and DUS measurement at baseline were similar. HG increased in both groups at the end of the study (CG 24.5 ± 9.5 vs. 26.1 ± 10.1 kg, p 0.048; ESG 25.8 ± 10.3 vs. 26.3 ± 11.6 kg, p 0.644). RCAVF forearm vein diameter (CG 3.1 ± 0.7 vs. 5.7 ± 1.1 mm; ESG 2.9 ± 0.8 vs. 6.1 ± 1.7 mm) and humeral artery blood flow rate (CG 110.5 ± 20.7 vs. 1053.4 ± 510.7 ml/min; ESG 118.2 ± 31.6 vs. 954.1 ± 542.2 ml/min) statistically increased for both groups. A significant increase in clinical maturation in ESG (62.5 vs. 91.7%, p 0.046) at 8 weeks was observed. Four patients in each group developed juxta-anastomotic stenosis and were surgically repaired. No adverse NMES effects were registered. CONCLUSIONS: NMES of forearm muscles is a safe and effective technique to improve RCAVF maturation and constitutes a novel alternative to forearm isometrics exercises. Nevertheless, further studies are required to confirm the potential effect of NMES in the vascular access maturation process.

Effects of neuromuscular electrical stimulation on cytokines in peripheral blood for healthy participants: a prospective, single-blinded Study.

INTRODUCTION: The effect of exercise on cytokines may improve muscle strength. Neuromuscular electrical stimulation (NMES) is a muscle-preserving therapy that benefits patients unable to participate in active exercise. How NMES alters cytokines is unclear. The aim of this study was to study the effects of 1 NMES session on cytokines associated with protein metabolism during exercise. METHODS: We evaluated the effects of NMES on IL-1, IL-6, IL-10 and TNF-α levels in peripheral blood. Participants received NMES to bilateral lower extremity muscles (quadriceps, tibialis anterior, gastrocnemius) for 30 min. Blood samples immediately pre- and post-NMES were drawn at 15-min intervals to 2-h follow-up, and the mean values of pre-NMES levels were compared to peak and trough post-NMES levels. For cytokines with significant changes, we conducted a repeated-measures linear regression analysis. We also measured post-NMES lactate and creatine kinase levels. RESULTS: We enrolled nine eligible participants. There was a significant increase in peak IL-6 from the mean pre-NMES value [0·65 (0·89) to 1·04 (0·89) pg ml-1 , P = 0·001] and a significant decrease in trough IL-1 [0·08 (0·07) to 0·02 (0·02) pg ml-1 , P = 0·041] and TNF-α [2·42 (0·54) to 2·16 (0·59) pg ml-1 , P = 0·021]. In repeated-measures regression analysis, we identified significantly higher mean IL-6 values throughout the full 120 min post-NMES period, and a significantly higher mean IL-1 value at 30 min post-NMES. There were no significant differences in peak IL-10, trough IL-6, lactate, or creatine kinase values. CONCLUSIONS: In nine healthy humans, 30 min of NMES was temporally associated with changes in cytokines similar to the effects of active exercise and may mediate NMES' observed effects on reducing muscle weakness.

Efficacy of neuromuscular electrostimulation intervention to improve physical function in haemodialysis patients.

BACKGROUND: Haemodialysis (HD) patients are characterised by muscle wasting, decreased physical function and poor quality of life. The objective was to analyse the effect of an intradialysis NMES training programme in muscular strength, functional capacity and quality of life in our HD patients. MATERIAL: HD patients were assigned to NMES (ESG) or control group (CG) in a 12-week single-centre prospective study. Transversal quadriceps muscular area, maximum length quadriceps strength (MLQS), handgrip, sit-to-stand-to-sit 10 test (STS10), "6-min walking test" (6MWT); EuroQol-5D health-related quality of life (EQ-5D) questionnaire, subjective global assessment (SGA) and NMES symptoms questionnaires (SQ) were completed. RESULTS: Thirty-eight patients (54 % men). Mean age 69.7 years. 32.1 months on HD, 23 ESG and 15 in CG. In contrast with CG, ESG significantly (*p < 0.05) improved MLQS* (10.2 6.7 vs. 13.1 8.1 kg), STS10* (41 18.7 vs. 37.2 23.9 s), 6MWT* (12 %, 280.5 vs. 312.4 m) and EQ-5D score* (52.7 vs. 65.5) at the end of the study. However, lower SQ score* (8.5 vs. 5.8 sympt./patient) in ESG was observed, mainly due to muscular pain* (2.2 vs. 1.2), cramps* (1.6 vs. 1.2), numbness* (1.7 vs. 1.1) or stinging* (1.5 vs. 1.1). In ESG, 44 and 72 % referred better wellness sensation and physical condition in SGA, respectively. CONCLUSIONS: Intradialytic NMES of both quadriceps improved muscular strength, functional capacity and quality of life in our HD patients. With the obtained results, NMES constitutes a novel therapeutic alternative to improve the deteriorated physical condition and quality of life of these patients.

Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries.

The intrinsic muscles of the foot play a critical role in the regulation of absorption and propulsion during dynamic activities. Dysfunction of these may lead to an increased demand on the remaining components within the foot core system to maintain dynamic foot control, leading to a more rapid breakdown of these contributors and those proximal to the foot. Training the intrinsic foot muscles through a systematic progression of isolation via the short foot exercise offers the opportunity to reincorporate their contribution into the foot core system. This article discusses the function of the intrinsic foot muscles, their contributions to dynamic foot control, and a progressive training paradigm.