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This study investigates the effects of varying loading conditions on excitability in neural pathways and gait dynamics. We focussed on evaluating the magnitude of the Hoffman reflex (H-reflex), a neurophysiological measure representing the capability to activate motor neurons and the timing and placement of the foot during walking. We hypothesized that weight manipulation would alter H-reflex magnitude, footfall and lower body kinematics. Twenty healthy participants were recruited and subjected to various weight-loading conditions. The H-reflex, evoked by stimulating the tibial nerve, was assessed from the dominant leg during walking. Gait was evaluated under five conditions: body weight, 20% and 40% additional body weight, and 20% and 40% reduced body weight (via a harness). Participants walked barefoot on a treadmill under each condition, and the timing of electrical stimulation was set during the stance phase shortly after the heel strike. Results show that different weight-loading conditions significantly impact the timing and placement of the foot and gait stability. Weight reduction led to a 25% decrease in double limb support time and an 11% narrowing of step width, while weight addition resulted in an increase of 9% in step width compared to body weight condition. Furthermore, swing time variability was higher for both the extreme weight conditions, while the H-reflex reduced to about 45% between the extreme conditions. Finally, the H-reflex showed significant main effects on variability of both stance and swing phases, indicating that muscle-motor excitability might serve as feedback for enhanced regulation of gait dynamics under challenging conditions.
Assuntos
Marcha , Reflexo H , Caminhada , Suporte de Carga , Humanos , Marcha/fisiologia , Reflexo H/fisiologia , Masculino , Adulto , Feminino , Suporte de Carga/fisiologia , Fenômenos Biomecânicos/fisiologia , Adulto Jovem , Caminhada/fisiologia , Estimulação Elétrica/métodos , Músculo Esquelético/fisiologia , Nervo Tibial/fisiologia , Eletromiografia , Pé/fisiologia , Adaptação Fisiológica/fisiologia , Neurônios Motores/fisiologia , Peso Corporal/fisiologiaRESUMO
The restoration of adequate function and sensation in nerves following an injury is often insufficient. Electrical stimulation (ES) applied during nerve repair can promote axon regeneration, which may enhance the likelihood of successful functional recovery. However, increasing operation time and complexity are associated with limited clinical use of ES. This study aims to better assess whether short-duration ES types (voltage mode vs. current mode) are able to produce enhanced regenerative activity following peripheral nerve repair in rat models. Wistar rats were randomly divided into 3 groups: no ES (control), 30-minute ES with a current pulse, and 30-minute ES with a voltage pulse. All groups underwent sciatic nerve transection and repair using a silicone tube to bridge the 6-mm gap between the stumps. In the 2 groups other than the control, ES was applied after the surgical repair. Outcomes were evaluated using electrophysiology, histology, and serial walking track analysis. Biweekly walking tracks test over 12 weeks revealed that subjects that underwent ES experienced more rapid functional improvement than subjects that underwent repair alone. Electrophysiological analysis of the newly intratubular sciatic nerve at week 12 revealed strong motor function recovery in rats that underwent 30-minute ES. Histologic analysis of the sciatic nerve and its tibial branch at 12 weeks demonstrated robust axon regrowth in all groups. Both types of short-duration ES applied during nerve repair can promote axon regrowth and enhance the chances of successful functional recovery.
Assuntos
Axônios , Regeneração Nervosa , Ratos Wistar , Recuperação de Função Fisiológica , Nervo Isquiático , Animais , Regeneração Nervosa/fisiologia , Nervo Isquiático/lesões , Axônios/fisiologia , Recuperação de Função Fisiológica/fisiologia , Ratos , Estimulação Elétrica/métodos , Nervo Tibial/lesões , Masculino , Terapia por Estimulação Elétrica/métodosRESUMO
INTRODUCTION/AIMS: It is unclear whether the revised European Academy of Neurology/Peripheral Nerve Society diagnostic criteria (EAN/PNS 2021 criteria) improved the diagnostic yield for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) compared with the previous version. Therefore, this study aimed to compare the sensitivity and specificity of the EAN/PNS 2021 criteria and the European Federation of Neurological Societies/Peripheral Nerve Society 2010 diagnostic criteria (EFNS/PNS 2010 criteria), with a specific focus on the electrodiagnostic criteria. METHODS: Data of patients with clinically suspected CIDP who exhibited objective treatment response, and of those with chronic axonal neuropathies, obtained between 2009 and 2021, were extracted retrospectively from our database. Patients who underwent nerve conduction studies in at least unilateral upper and lower extremities were enrolled. We compared the sensitivity and specificity of the EAN/PNS 2021 and EFNS/PNS 2010 criteria. RESULTS: In total, 55 patients with clinically suspected CIDP and 36 patients with chronic axonal neuropathies were enrolled. When considering the "possible CIDP" category, the EAN/PNS 2021 criteria showed lower sensitivity than the EFNS/PNS 2010 criteria (78% vs. 93%, p < .05), whereas its specificity was higher (78% vs. 61%, p < .05). The lower sensitivity was caused mainly by the failure to fulfill the sensory nerve conduction criteria. The revised definition of abnormal temporal dispersion of the tibial nerve contributed markedly to the improved specificity. DISCUSSION: To improve the sensitivity of the EAN/PNS 2021 criteria, increasing the number of tested sensory nerves may be necessary.
Assuntos
Polirradiculoneuropatia Desmielinizante Inflamatória Crônica , Humanos , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica/diagnóstico , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica/terapia , Estudos Retrospectivos , Nervos Periféricos , Condução Nervosa/fisiologia , Nervo TibialRESUMO
INTRODUCTION/AIMS: Nerve conduction studies (NCSs) are widely used to support the clinical diagnosis of neuromuscular disorders. The aims of this study were to obtain reference values for peroneal, tibial, and sural NCSs and to examine the associations with demographic and anthropometric factors. METHODS: In 5099 participants (aged 40-79 years) without type 2 diabetes of The Maastricht Study, NCSs of peroneal, tibial, and sural nerves were performed. Values for compound muscle action potential (CMAP) and sensory nerve action potential amplitude, nerve conduction velocity (NCV), and distal latency were acquired. The association of age, sex, body mass index (BMI), and height with NCS values was determined using uni- and multivariate linear regression analyses. RESULTS: Detailed reference values are reported per decade for men and women. Significantly lower NCVs and longer distal latencies were observed in all nerves in older and taller individuals as well as in men. In these groups, amplitudes of the tibial and sural nerves were significantly lower, whereas a lower peroneal nerve CMAP was only significantly associated with age. BMI showed a multidirectional association. After correction for anthropometric factors in the multivariate analysis, the association between sex and NCS values was less straightforward. DISCUSSION: These values from a population-based dataset could be used as a reference for generating normative values. Our findings show the association of NCS values with anthropometric factors. In clinical practice, these factors can be considered when interpreting NCS values.
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Diabetes Mellitus Tipo 2 , Nervo Sural , Masculino , Humanos , Feminino , Idoso , Nervo Tibial/fisiologia , Estudos de Condução Nervosa , Condução Nervosa/fisiologia , Valores de Referência , Nervo Fibular/fisiologia , DemografiaRESUMO
OBJECTIVE: To evaluate the efficacy and safety of a wearable, smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB). PATIENTS AND METHODS: This multicentre, prospective, single-blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. Device-related adverse events (AEs) were also evaluated. RESULTS: In the full analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS (P = 0.05), while it was significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device-related serious AEs were reported. CONCLUSIONS: The non-invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home-based treatment modality. Future studies are warranted to confirm its longer-term efficacy.
Assuntos
Nervo Tibial , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Humanos , Bexiga Urinária Hiperativa/terapia , Feminino , Pessoa de Meia-Idade , Masculino , Método Simples-Cego , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos , Estimulação Elétrica Nervosa Transcutânea/métodos , Estimulação Elétrica Nervosa Transcutânea/instrumentação , Estudos Prospectivos , Resultado do Tratamento , Idoso , Dispositivos Eletrônicos Vestíveis , Adulto , Qualidade de VidaRESUMO
AIMS: The aims of the present study were to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) on overactive bladder (OAB) symptoms and on urodynamic parameters in patients with multiple sclerosis (PwMS) and to seek predictive factors of satisfaction. METHODS: All PwMS who performed 12-24 weeks of TTNS and who underwent urodynamic assessment before and after treatment between June 2020 and October 2022 were included retrospectively. Data collected were bladder diaries, symptoms assessed with Urinary Symptoms Profile (USP), and urodynamic parameters (bladder sensations, detrusor overactivity, and voiding phase). Patients with improvement rated as very good or good on Patient Global Impression of Improvement (PGI-I) score were considered as responders. RESULTS: Eighty-two patients were included (mean age: 47.1 ± 11.5 years, 67 (82%) were women). The mean USP OAB sub-score decreased from 7.7 ± 3.5 to 6.0 ± 3.4 (p < 0.0001). On bladder diaries, voided volumes, void frequency, and the proportion of micturition done at urgent need to void significantly improved with TTNS (p < 0.05). No significant change was found in urodynamic parameters. According to the PGI-I, 34 (42.5%) patients were good responders. The only parameter associated with higher satisfaction was the percentage of micturition done at urgent need to void before the initiation of the treatment (39.8% ± 30.5 in the responder group vs 25.1% ± 25.6 in the low/no responder group; p = 0.04). CONCLUSION: TTNS improves OAB symptoms in PwMS, without significant changes on urodynamics. A high rate of strong or urgent need to void in daily life was associated with higher satisfaction.
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Esclerose Múltipla , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Masculino , Bexiga Urinária Hiperativa/complicações , Urodinâmica/fisiologia , Esclerose Múltipla/complicações , Esclerose Múltipla/terapia , Estudos Retrospectivos , Nervo Tibial , Resultado do TratamentoRESUMO
The soleus H-reflex modulation pattern was investigated during stepping following transspinal stimulation over the thoracolumbar region at 15, 30, and 50 Hz with 10 kHz carry-over frequency above and below the paresthesia threshold. The soleus H-reflex was elicited by posterior tibial nerve stimulation with a single 1 ms pulse at an intensity that the M-wave amplitudes ranged from 0 to 15% of the maximal M-wave evoked 80 ms after the test stimulus, and the soleus H-reflex was half the size of the maximal H-reflex evoked on the ascending portion of the recruitment curve. During treadmill walking, the soleus H-reflex was elicited every 2 or 3 steps, and stimuli were randomly dispersed across the step cycle which was divided in 16 equal bins. For each subject and condition, the soleus M-wave and H-reflex were normalized to the maximal M-wave. The soleus background electromyographic (EMG) activity was estimated as the linear envelope for 50 ms duration starting at 100 ms before posterior tibial nerve stimulation for each bin. The gain was determined as the slope of the relationship between the soleus H-reflex and the soleus background EMG activity. The soleus H-reflex phase-dependent amplitude modulation remained unaltered during transspinal stimulation, regardless frequency, or intensity. Similarly, the H-reflex slope and intercept remained the same for all transspinal stimulation conditions tested. Locomotor EMG activity was increased in knee extensor muscles during transspinal stimulation at 30 and 50 Hz throughout the step cycle while no effects were observed in flexor muscles. These findings suggest that transspinal stimulation above and below the paresthesia threshold at 15, 30, and 50 Hz does not block or impair spinal integration of proprioceptive inputs and increases activity of thigh muscles that affect both hip and knee joint movement. Transspinal stimulation may serve as a neurorecovery strategy to augment standing or walking ability in upper motoneuron lesions.
Assuntos
Eletromiografia , Reflexo H , Músculo Esquelético , Caminhada , Humanos , Reflexo H/fisiologia , Caminhada/fisiologia , Masculino , Músculo Esquelético/fisiologia , Adulto , Adulto Jovem , Feminino , Estimulação Elétrica/métodos , Nervo Tibial/fisiologia , Medula Espinal/fisiologiaRESUMO
OBJECTIVES: To assess the correlation between the response to transcutaneous tibial nerve stimulation (TTNS) and subsequent response to sacral nerve modulation (SNM) to treat overactive bladder (OAB). MATERIALS AND METHODS: All patients who consecutively received TTNS followed by a two-stage SNM between January 2016 and June 2022 to treat OAB in two university hospital centers were included. The response to each therapy was evaluated with success defined by a 50% or greater improvement in one or more bothersome urinary symptoms from baseline. The primary endpoint was the statistical relationship between the response to TTNS and the response to SNM, assessed by logistic regression. Secondary endpoints were the statistical relationship between the response to TTNS and the response to SNM when controlling for gender, age (<57 years vs. >57 years), presence of an underlying neurological disease, and presence of DO, adding the factor and interaction to the previous regression model. RESULTS: Among the 92 patients enrolled in the study, 68 of them were women (73.9%), and the median age was 57.0 [41.0-69.0] years. The success was reported in 22 patients (23.9%) under TTNS and 66 patients (71.7%) during the SNM test phase. There was no statistical correlation between response to TTNS and response to SNM in the overall population (confidence interval: 95% [0.48-4.47], p = 0.51). Similarly, there was no statistical correlation when controlling for age <57 years or ≥57 years, with p = 1.0 and p = 0.69, respectively. No statistical study could be conducted for the other subpopulations due to small sample sizes. CONCLUSION: The response to TTNS does not predict the response to SNM in the treatment of OAB. TTNS and SNM should be considered as separate therapies, and the decision-making process for OAB treatment should take this into account.
Assuntos
Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Bexiga Urinária Hiperativa/terapia , Resultado do Tratamento , Nervo TibialRESUMO
BACKGROUND: Lower urinary tract dysfunction (LUTD) is a common, troublesome condition that often negatively affects patients' quality of life. Current literature has long been interested in how posterior tibial nerve stimulation (PTNS) can affect this condition. AIM: To extensively and systematically explore how PTNS affects LUTD based on the most recent systematic reviews. METHODS: A systematic search was conducted in PubMed, Scopus, Web of Science, and Embase according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the systematic reviews, with or without meta-analysis that assessed the effects of PTNS on LUTD were retrieved. The quality of the included studies was assessed using the Joanna Briggs Institute tool, and analysis was conducted using the Comprehensive Meta-Analysis version 3 tool. RESULTS: From a total of 3077 citations, 20 systematic reviews entered this study, and 13 of them included meta-analysis. The population of studies varied vastly, for instance, some studies included only children or women while other focused on a specific pathology like multiple sclerosis-induced neurogenic LUTD. The majority of included studies reported an overall improvement in LUTD following percutaneous PTNS, although admitting that these results were derived from moderate to low-quality evidence. CONCLUSION: The findings of this thorough umbrella review showed that the positive benefits of PTNS in treating LUTD are currently supported by low-quality evidence, and it is crucial to interpret them with great care.
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Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Criança , Feminino , Humanos , Qualidade de Vida , Nervo Tibial , Resultado do Tratamento , Bexiga Urinária , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVES: A feasibility proof-of-concept study was conducted to assess the effects of acute tibial nerve stimulation (TNS) on the central nervous system in healthy volunteers using functional magnetic resonance imaging (fMRI). MATERIALS AND METHODS: Fourteen healthy volunteers were included in a prospective, single-site study conducted on a clinical 3T MRI scanner. Four scans of functional MRI, each lasting 6 min, were acquired: two resting-state fMRI scans (prior and following the TNS intervention) and in-between two fMRI scans, both consisting of alternating rest periods and noninvasive acute transcutaneous TNS (TTNS). Whole brain seed-based functional connectivity (FC) correlation analysis was performed comparing TTNS stimulation with rest periods. Cluster-level familywise error (FWE) corrected p and a minimal cluster size of 200 voxels were used to explore FC patterns. RESULTS: Increased FC is reported between inferior frontal gyrus, posterior cingulate gyrus, and middle temporal gyrus with the precuneus as central receiving node. In addition, decreased FC in the cerebellum, hippocampus, and parahippocampal areas was observed. CONCLUSIONS: Altered FC is reported in areas which have been described to be also involved in lower urinary tract control. Although conducted with healthy controls, the assumption that the underlying therapeutic effect of TNS involves the central nervous system is supported and has to be further examined in patients with incomplete spinal cord injury.
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Encéfalo , Imageamento por Ressonância Magnética , Humanos , Imageamento por Ressonância Magnética/métodos , Estudos Prospectivos , Mapeamento Encefálico/métodos , Nervo Tibial/diagnóstico por imagemRESUMO
PURPOSE: Percutaneous Tibial Neuromodulation (PTNM) is used to treat Overactive Bladder (OAB). This analysis summarizes patient adherence to PTNM treatment and examines trends of other third-line therapy use during and after PTNM. METHODS: Optum's deidentified Clinformatics® Data Mart Database (CDM) and CMS Research Identifiable Files were queried for adults with OAB symptoms and who underwent PTNM treatment (2019-2020). We evaluated the proportion of patients who completed 12 visits within 1 year, and defined patients as treatment compliant if 12 PTNM visits were completed within 12 weeks. We then identified the proportion of patients who used other third-line therapies after PTNM and stratified these patients based on their PTNM therapy compliance status. RESULTS: 2302 patients met selection criteria from CDM and 16,473 patients from CMS. The proportion of patients completing a full PTNM treatment course increased over time; from 16% at week 12% to 42% by week 52 (CDM) and 24% to 38% (CMS). Other third-line therapy use increased over time and was higher for PTNM noncompliant versus compliant patients at 52 weeks: onabotulinumtoxinA was 6.5% versus 5.7% for noncompliant versus compliant (CMS, p = 0.0661) and 6.4% versus 4.9% (CDM, p = 0.035), SNM trial procedure was 6.5% versus 2.5% (CDM, p = 0.002) and 4.2% versus 2.0% (CMS, p = 0.010). CONCLUSIONS: Most patients are noncompliant with recommended PTNM treatment regimen. Albeit low, third-line therapy was pursued more frequently by noncompliant patients. Given low compliance, the effectiveness of PTNM may be compromised. Alternative implantable technologies may be needed to assure effectiveness of neuromodulation.
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Cooperação do Paciente , Nervo Tibial , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Humanos , Bexiga Urinária Hiperativa/terapia , Bexiga Urinária Hiperativa/fisiopatologia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Adulto , Resultado do TratamentoRESUMO
INTRODUCTION: Third-line therapies for overactive bladder (OAB) that are currently recommended include intravesical Onabotulinumtoxin-A injections (BTX-A), percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). The implantable tibial nerve stimulator (ITNS) is a novel therapy that is now available to patients with OAB. OBJECTIVE: The objective of this study was to analyze shifts in patient preference of third-line therapies for OAB after introducing ITNS as an option among the previously established therapies for non-neurogenic OAB. METHODS: A survey was designed and distributed via SurveyMonkey to the platform's audience of U.S. adults of age 18 and older. Screening questions were asked to include only subjects who reported symptoms of OAB. Descriptions of current AUA/SUFU guideline-approved third-line therapies (BTX-A, PTNS, and SNM) were provided, and participants were asked to rank these therapies in order of preference (stage A). Subsequently, ITNS was introduced with a description, and participants were then asked to rank their preferences amongst current guideline-approved therapies and ITNS (stage B). Absolute and relative changes in therapy preferences between stage A and stage B were calculated. Associations between ultimate therapy choice in stage B and participant characteristics were analyzed. RESULTS: A total of 485 participants completed the survey (62.5% female). The mean age was 49.1 ± 36.5 years (SD). The most common OAB symptoms reported were urgency urinary incontinence (UUI) (73.0%) and urinary urgency (68.0%). 29.2% of patients had tried medication for OAB in the past, and 8.0%-10.3% of patients were previously treated with a third-line therapy for OAB. In stage A, participants ranked their first choice of third-line therapy as follows: 28% BTX-A, 27% PTNS, and 13.8% SNM. 26.6% of participants chose no therapy, and 4.5% chose all three equally. In stage B, participants ranked their first choice as follows: 27.6% BTX-A, 19.2% PTNS, 7.8% SNM, and 19.2% ITNS. 21.9% of participants chose no therapy and 4.3% chose all four equally as their first choice. There were both absolute and relative declines in proportions of patients interested in BTX-A, SNM, and PTNS as their first choice of third-line therapy with the introduction of ITNS. Patients originally interested in PTNS in stage A had the greatest absolute change after the introduction of ITNS with 7.8% of participants opting for ITNS in stage B. Those interested in SNM in stage A had the largest relative change in interest, with 43.5% of those originally interested in SNM opting for ITNS in stage B. Finally, with the introduction of ITNS, the number of participants initially not interested in any third-line therapy declined by an absolute change of 4.7% and relative change of 17.6%. Participants experiencing concurrent stress urinary incontinence (SUI) symptoms were more likely to choose a current guideline-approved third-line therapy than ITNS or no therapy at all (p = 0.047). Those who had prior experience with third-line therapies were more likely to choose a third-line therapy other than ITNS as their ultimate choice of therapy in stage B. Of those who had chosen a guideline-approved third-line therapy in stage B (not ITNS), 13.6% had prior experience with BTX-A, 14.7% with PTNS, and 32 (11.2%) with SNM (p < 0.001, p < 0.001, p = 0.009, respectively). CONCLUSION: From our study, it appears that ITNS may attract a subset of patients who would not have otherwise pursued current guideline-approved third-line therapies for OAB. When patients are provided with descriptions of third-line OAB therapies including ITNS as an option, ITNS appears to compete with SNM and PTNS. It is possible that ITNS will provide patients with a different phenotype of neuromodulation therapy that can appeal to a niche OAB population. Given that ITNS devices have been introduced relatively recently to the market, their application will largely depend on cost and payer coverage, provider bias, and patient comorbidities. Further study is needed to understand how these factors interact with and influence patient preference of advanced OAB therapy to understand which patients will most benefit from this treatment modality.
Assuntos
Toxinas Botulínicas Tipo A , Terapia por Estimulação Elétrica , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Adulto , Humanos , Feminino , Criança , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Bexiga Urinária Hiperativa/terapia , Preferência do Paciente , Toxinas Botulínicas Tipo A/uso terapêutico , Nervo Tibial , Resultado do TratamentoRESUMO
BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.
Assuntos
Incontinência Urinária de Urgência , Humanos , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Incontinência Urinária de Urgência/terapia , Incontinência Urinária de Urgência/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Idoso , Resultado do Tratamento , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/instrumentação , Adulto , Neuroestimuladores Implantáveis/efeitos adversos , Bexiga Urinária Hiperativa/terapia , Bexiga Urinária Hiperativa/fisiopatologia , Bexiga Urinária Hiperativa/diagnóstico , Nervo Tibial/fisiopatologiaRESUMO
OBJECTIVE: Ultrasound-guided tibial nerve pulsed radiofrequency (US-guided TN PRF) and fluoroscopy-guided intralesional radiofrequency thermocoagulation (FL-guided intralesional RFT) adjacent to the painful calcaneal spur are two interventions for pain management in painful calcaneal spur and plantar fasciitis. This study aimed to compare the effectiveness of the two procedures. DESIGN: A prospective, randomized, single-blind study. SETTING: Single-center pain clinic. SUBJECTS: Forty-nine patients who met the inclusion criteria were randomized into two groups. METHODS: Group U (25 patients) received US-guided TN PRF at 42°C for 240 s, whereas Group F (24 patients) received FL-guided intralesional RFT at 80°C for 90 s. The most severe numeric rating scale (NRS) score during the first morning steps and the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scores were used to evaluate the effectiveness of the procedures. The study's primary outcome assessed treatment effectiveness via the NRS, whereas the secondary outcomes included changes in the AOFAS score and the incidence of procedure-related mild adverse events. RESULTS: NRS and AOFAS scores significantly improved in Groups U and F at 1 and 3 months compared with baseline (P < .05), and there was no significant difference between the groups. At month 1, 50% or greater pain relief was achieved in 72% of patients in Group U and 75% of patients in Group F. No significant difference was observed in the incidence of mild adverse events between the groups. CONCLUSIONS: US-guided TN PRF and FL-guided intralesional RFT have shown significant effectiveness in the treatment of painful calcaneal spur and plantar fasciitis. Larger randomized controlled trials are needed. CLINICAL TRIAL NUMBER: NCT06240507.
Assuntos
Eletrocoagulação , Fasciíte Plantar , Tratamento por Radiofrequência Pulsada , Nervo Tibial , Humanos , Fasciíte Plantar/terapia , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Método Simples-Cego , Tratamento por Radiofrequência Pulsada/métodos , Eletrocoagulação/métodos , Esporão do Calcâneo/terapia , Estudos Prospectivos , Ultrassonografia de Intervenção/métodos , Resultado do Tratamento , Manejo da Dor/métodosRESUMO
BACKGROUND: Peripheral nerve stimulation with a train-of-four (TOF) pattern can be used intraoperatively to evaluate the depth of neuromuscular block and confirm recovery from neuromuscular blocking agents (NMBAs). Quantitative monitoring can be challenging in infants and children due to patient size, equipment technology, and limited access to monitoring sites. Although the adductor pollicis muscle is the preferred site of monitoring, the foot is an alternative when the hands are unavailable. However, there is little information on comparative evoked neuromuscular responses at those 2 sites. METHODS: Pediatric patients undergoing inpatient surgery requiring NMBA administration were studied after informed consent. Electromyographic (EMG) monitoring was performed simultaneously in each participant at the hand (ulnar nerve, adductor pollicis muscle) and the foot (posterior tibial nerve, flexor hallucis brevis muscle). RESULTS: Fifty patients with a mean age of 3.0 ± standard deviation (SD) 2.9 years were studied. The baseline first twitch amplitude (T1) of TOF at the foot (12.46 mV) was 4.47 mV higher than at the hand (P <.0001). The baseline TOF ratio (TOFR) before NMBA administration and the maximum TOFR after antagonism with sugammadex were not different at the 2 sites. The onset time until the T1 decreased to 10% or 5% of the baseline value (T1) was delayed by approximately 90 seconds (both P =.014) at the foot compared with the hand. The TOFR at the foot recovered (TOFR ≥0.9) 191 seconds later than when this threshold was achieved at the hand (P =.017). After antagonism, T1 did not return to its baseline value, a typical finding with EMG monitoring, but the fractional recovery (maximum T1 at recovery divided by the baseline T1) at the hand and foot was not different, 0.81 and 0.77, respectively (P =.68). The final TOFR achieved at recovery was approximately 100% and was not different between the 2 sites. CONCLUSIONS: Although this study in young children demonstrated the feasibility of TOF monitoring, interpretation of the depth of neuromuscular block needs to consider the delayed onset and the delayed recovery of TOFR at the foot compared to the hand. The delay in achieving these end points when monitoring the foot may impact the timing of tracheal intubation and assessment of adequate recovery of neuromuscular block to allow tracheal extubation (ie, TOFR ≥0.9).
Assuntos
Eletromiografia , Músculo Esquelético , Bloqueio Neuromuscular , Humanos , Masculino , Feminino , Eletromiografia/métodos , Estudos Prospectivos , Pré-Escolar , Músculo Esquelético/inervação , Músculo Esquelético/fisiologia , Criança , Bloqueio Neuromuscular/métodos , Lactente , Pé , Estimulação Elétrica , Nervo Ulnar , Mãos/inervação , Bloqueadores Neuromusculares/administração & dosagem , Monitoração Neuromuscular/métodos , Nervo TibialRESUMO
INTRODUCTION AND HYPOTHESIS: The aim of this study is to compare the effectiveness of transcutaneous tibial nerve stimulation (TTNS) on quality of life (QoL) and clinical parameters related to incontinence in pharmacological agents (PhAs) naive and refractory women with idiopathic overactive bladder (iOAB). METHODS: In this prospective nonrandomized clinical trial, women with resistance to PhAs were included in the first group (n=21), PhA-naive women were included in the second group (n=21). TTNS was performed 2 days a week, a total of 12 sessions for 6 weeks. Every session lasted 30 min. Women were evaluated for the severity of incontinence (Pad test), 3-day voiding diary (voiding frequency, nocturia, incontinence episodes, and number of pads), symptom severity (Overactive Bladder Questionnaire-V8), quality of life (Incontinence Impact Questionnaire-7), treatment satisfaction, positive response, and cure-improvement rates. RESULTS: A statistically significant improvement was found in all parameters for each group at the 6th week compared with the baseline values (p<0.05). It was found that the severity of incontinence, incontinence episodes, symptom severity, treatment satisfaction, and QoL parameters were significantly improved in PhA-naive group compared with the PhA-resistant group at the 6th week (p<0.05). There were no statistically significant differences in the frequency of voiding, nocturia, and number of pads between the two groups (p>0.05). Positive response rates, the primary outcome measure, were statistically significantly higher in the PhA-naive group than in the PhA-resistant group. CONCLUSIONS: Although TTNS is more effective in PhA-naive women with iOAB, it appears to be an effective therapy that can also be used in the management of PhA-resistant women with iOAB.
Assuntos
Noctúria , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Incontinência Urinária , Humanos , Feminino , Bexiga Urinária Hiperativa/tratamento farmacológico , Qualidade de Vida , Estudos Prospectivos , Resultado do Tratamento , Nervo Tibial , Incontinência Urinária/terapiaRESUMO
INTRODUCTION AND HYPOTHESIS: The goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity. METHODS: Planned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline. FI severity was measured using the seven-item validated St. Mark's (Vaizey) FI severity scale. Participants also completed a 7-day bowel diary capturing the number of FI-free days, FI events, and bowel movements per week. Spearman's correlations were calculated between dietary, St. Mark's score, and bowel diary measures. RESULTS: One hundred and eighty-six women were included in this analysis. Mean calories from fats were 32% (interquartile range [IQR] 30-35%). Mean dietary fiber intake was 13.9 ± 4.3 g. The percentage of calories from fats was at the higher end of recommended values, whereas fiber intake was lower than recommended for adult women (recommended values: calories from fat 20-35% and 22-28 g of fiber/day). There was no correlation between St. Mark's score and fat intake (r = 0.11, p = 0.14) or dietary fiber intake (r = -0.01, p = 0.90). There was a weak negative correlation between the number of FI-free days and total fat intake (r = -0.20, p = 0.008). Other correlations between dietary fat/fiber intake and bowel diary measures were negligible or nonsignificant. CONCLUSION: Overall, in women with moderate to severe FI, there was no association between FI severity and dietary fat/fiber intake. Weak associations between FI frequency and fat intake may suggest a role for dietary assessment in the evaluation of women with FI.
Assuntos
Gorduras na Dieta , Fibras na Dieta , Incontinência Fecal , Índice de Gravidade de Doença , Humanos , Feminino , Fibras na Dieta/administração & dosagem , Pessoa de Meia-Idade , Gorduras na Dieta/administração & dosagem , Adulto , Idoso , Inquéritos e Questionários , Estimulação Elétrica Nervosa Transcutânea , Nervo TibialRESUMO
Overactive bladder (OAB) is a highly prevalent condition with significant associated comorbidities. Current management guidelines suggest the utilization of anticholinergic medication as a second line after nonpharmacological treatment. Tibial nerve stimulation (TNS), which has previously been thought to have been expensive and inaccessible, was relegated to a third-line therapy. However, given the recently discovered association between anticholinergic medication use and dementia as well as the recent FDA approval of transcutaneous tibial nerve stimulation (TTNS), there may be a need to revisit management guidelines. In this commentary, we identify the two types of TNS, percutaneous tibial nerve stimulation (PTNS) and TTNS and compare them with anticholinergics. By considering their respective efficacies, side-effects profiles, and associated costs, we make the case in this commentary for an update to guidelines that includes TNS as second-line OAB management ahead of anticholinergic medication.
Assuntos
Antagonistas Colinérgicos , Nervo Tibial , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Bexiga Urinária Hiperativa/terapia , Bexiga Urinária Hiperativa/tratamento farmacológico , Humanos , Antagonistas Colinérgicos/efeitos adversos , Antagonistas Colinérgicos/uso terapêutico , Feminino , Guias de Prática Clínica como AssuntoRESUMO
PURPOSE: This study aims at comparing acute responses in spinal excitability, as measured by H-reflex, between older and young individuals, following a single session of NMES superimposed onto voluntary isometric contractions of the ankle plantar-flexor muscles (NMES+), with respect to passive NMES (pNMES) and voluntary isometric contractions only (ISO). METHODS: Thirty-two volunteers, 16 older (OLDER) and 16 young (YOUNG), were asked to sustain a constant force at 20% of maximal voluntary isometric contraction (MVIC) of the ankle plantar-flexor muscles in the dominant limb during each of the 3 conditions (NMES+ , pNMES and ISO). Fifteen repetitions of 6 s were performed, with a resting interval of 6 s between repetitions. Before and after each condition, soleus H-reflexes were elicited by percutaneous electrical stimulation of the posterior tibial nerve and H-reflex amplitudes recorded by surface EMG. RESULTS: In OLDER, H-reflex amplitude did not change following any experimental condition (ISO: p = 0.203; pNMES: p = 0.542; NMES+: p = 0.431) compared to baseline. On the contrary, in YOUNG, H-reflex amplitudes significantly increased (p < 0.000) and decreased (p = 0.001) following NMES+ and pNMES, respectively, while there was no significant change in reflex responses following ISO (p = 0.772). CONCLUSION: The lack of change in H-reflex responses following either NMES+ or pNMES might reflect a reduced ability of older people in modulating spinal excitability after the conditions. Specifically, an age-related alteration in controlling mechanisms at presynaptic level was suggested.
Assuntos
Músculo Esquelético , Nervo Tibial , Humanos , Idoso , Adolescente , Músculo Esquelético/fisiologia , Eletromiografia/métodos , Nervo Tibial/fisiologia , Reflexo/fisiologia , Estimulação Elétrica/métodos , Reflexo H/fisiologia , Contração Muscular/fisiologiaRESUMO
OBJECTIVE: The objective of this study was to evaluate the long-term effectiveness of selective tibial neurotomy (STN) for the treatment of the spastic foot using a goal-centered approach. METHODS: Between 2011 and 2018, adult patients with a spastic foot (regardless of etiology) who received STN followed by a rehabilitation program were included. The primary outcome was the achievement of individual goals defined preoperatively (T0) and compared at 1-year (T1) and 5-year (T5) follow-up by using the Goal Attainment Scaling methodology (T-score). The secondary outcomes were the presence of spastic deformities (equinus, varus, and claw toes), modified Ashworth scale (MAS) score for the targeted muscles, and modified Rankin Scale (mRS) score at T0, T1, and T5. RESULTS: Eighty-eight patients were included. At T5, 88.7% of patients had achieved their goals at least "as expected." The mean T-score was significantly higher at T1 (62.5 ± 9.5) and T5 (60.6 ± 11.3) than at T0 (37.9 ± 2.8) (p < 0.0001), and the difference between T1 and T5 was not significant (p = 0.2). Compared to T0, deformities (equinus, varus, and claw toes; all p < 0.0001), MAS score (p < 0.0001), and mRS score (p < 0.0001) were significantly improved at T1 and T5. Compared to T1, MAS score increased slightly only at T5 (p = 0.05) but remained largely below the preoperative value. There was no difference between T1 and T5 regarding other clinical parameters (e.g., deformities, walking abilities, mRS score). CONCLUSIONS: This study found that STN associated with a postoperative rehabilitation program can enable patients to successfully achieve personal goals that are sustained within a 5-year follow-up period.