Comprehensive Assessment of the Time Course of Biomechanical, Electrophysiological and Neuro-Motor Effects after Botulinum Toxin Injections in Elbow Flexors of Chronic Stroke Survivors with Spastic Hemiplegia: A Cross Sectional Observation Study.

Botulinum neurotoxin (BoNT) is commonly used to manage focal spasticity in stroke survivors. This study aimed to a perform comprehensive assessment of the effects of BoNT injection. Twelve stroke subjects with spastic hemiplegia (age: 52.0 ± 10.1 year; 5 females) received 100 units of BoNT to the spastic biceps brachii muscles. Clinical, biomechanical, electrophysiological, and neuro-motor assessments were performed one week (wk) before (pre-injection), 3 weeks (wks) after, and 3 months (mons) after BoNT injection. BoNT injection significantly reduced spasticity, muscle strength, reflex torque, and compound muscle action potential (CMAP) amplitude of spastic elbow flexors (all p < 0.05) during the 3-wks visit, and these values return to the pre-injection level during the 3-mons visit. Furthermore, the degree of reflex torque change was negatively correlated to the amount of non-reflex component of elbow flexor resistance torque. However, voluntary force control and non-reflex resistance torque remained unchanged throughout. Our results revealed parallel changes in clinical, neurophysiological and biomechanical assessment after BoNT injection; BoNT injection would be more effective if hypertonia was mainly mediated by underlying neural mechanisms. BoNT did not affect voluntary force control of spastic muscles.

The Impact of Socioeconomic Status on Voice Outcomes in Patients With Spasmodic Dysphonia Treated With Botulinum Toxin Injections.

OBJECTIVES:: To determine the impact of socioeconomic status (SES) on voice outcomes for spasmodic dysphonia (SD) patients treated with botulinum toxin injections. METHODS:: This was a prospective cross-sectional study in a tertiary care, academic voice clinic in Canada. Adult SD patients returning to the voice clinic for their botulinum toxin injections were recruited from October 2017 to April 2018. Patients completed a questionnaire on demographic data, the Hollingshead Four-Factor Index for socioeconomic status (validated instrument based on education, occupation, gender, and marital status), and the Voice-Handicap Index 10 (VHI-10) (validated instrument on self-reported vocal handicap). Primary outcome was the association between VHI-10 and Hollingshead Index. Secondary variables were median household income by postal code, duration of disease, gender, age, and professional voice user. Descriptive statistics and multiple linear regression were conducted. RESULTS:: One hundred and one patients (age = 62.8 ± 13.7 years, 20.8% male) were recruited with VHI-10 of 22.1 ± 8.1 (out of 40) and Hollingshead Index of 46.3 ± 11.7 (range, 8-66). Median household income was $75 875 ± $16 393, which was above the Canadian average of $70 336. About 91.1% were Caucasian, 54.4% had university degree, 86.1% spoke English, and 43.5% were employed. In multiple linear regression, there was mild to moderate negative correlation (r = -.292, P = .004) between VHI-10 and Hollingshead Index when controlling for disease duration, age, gender, and professional voice use. CONCLUSION:: SD patients treated with botulinum toxin were mostly affluent, Caucasian, well educated, and English speakers. Lower self-perceived vocal handicap was associated with higher socioeconomic status.

Vulvodynia: Assessment and Treatment.

INTRODUCTION: Vulvodynia constitutes a highly prevalent form of sexual pain in women, and current information regarding its assessment and treatment is needed. AIM: To update the scientific evidence published in 2010, from the Third International Consultation on Sexual Medicine, pertaining to the assessment and treatment of women's sexual pain. METHODS: An expert committee, as part of the Fourth International Consultation on Sexual Medicine, was comprised of researchers and clinicians from biological and social science disciplines for the review of the scientific evidence on the assessment and treatment of women's genital pain. MAIN OUTCOME MEASURES: A review of assessment and treatment strategies involved in vulvodynia. RESULTS: We recommend the following treatments for the management of vulvodynia: psychological interventions, pelvic floor physical therapy, and vestibulectomy (for provoked vestibulodynia). We also support the use of multidisciplinary treatment approaches for the management of vulvodynia; however, more studies are needed to determine which components are most important. We recommend waiting for more empirical evidence before recommending alternative treatment options, anti-inflammatory agents, hormonal agents, and anticonvulsant medications. Although we do not recommend lidocaine, topical corticosteroids, or antidepressant medication for the management of vulvodynia, we suggest that capsaicin, botulinum toxin, and interferon be considered second-line avenues and that their recommendation be revisited once further research is conducted. CONCLUSION: A comprehensive assessment is needed to understand the pain experience of women presenting with vulvodynia. In addition, treatment typically progresses from less invasive to more invasive, and several treatment options are worth pursuing.

Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial.

BACKGROUND: Blepharospasm and hemifacial spasm are debilitating conditions that significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief, but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed-time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others, if symptoms return before the scheduled follow-up period. METHODS/DESIGN: A randomised controlled trial will compare a patient-initiated model of care, where patients determine botulinum toxin treatment timing, to the standard model of care in which care is scheduled by the clinical team. A sample of 266 patients with blepharospasm or hemifacial spasm will be recruited from Moorfields Eye Hospital (MEH), London. The trial will be accompanied by a mixed-methods evaluation of acceptability of the new service. Patients who meet eligibility criteria will be assessed at baseline and those in the intervention group will be provided with instructions on how to book their own treatment appointments. Patients in both groups will be followed up 3 and 9 months into the trial and all patients will be returned to usual care after 9 months to meet safety protocols. Primary outcome measures include disease severity (questionnaire), functional disability (questionnaire) and patient satisfaction with care (questionnaire). Secondary outcomes include disease-specific quality of life (questionnaire), mood (questionnaire), illness and treatment perceptions (questionnaire and semi-structured interviews), economic impact (questionnaire) and acceptability (questionnaire and semi-structured interviews). DISCUSSION: This trial will assess the effectiveness and cost-effectiveness of a patient-led care model for botulinum toxin therapy. If the new model is shown to be effective in reducing distress and disability in these populations and is found to be acceptable to patients, whilst being cost-effective, this will have significant implications for service organisation across the NHS. TRIAL REGISTRATION: UK Clinical Research Network (UKCRN) Portfolio 18660. Clinicaltrials.gov ID NCT102577224 (registered 29 October 2015).

Perfil de dispensação da toxina botulínica para tratamento da espasticidade: dados nacionais brasileiros / Dispensing profile of botulinum toxin for treating spasticity: Brazilian national data

Os fisiatras especializados no tratamento de espasticidade foram reunidos para um painel de discussão a respeito do uso de toxina botulínica (TB) na rede pública de diferentes estados do Brasil. Os dados analisados durante a discussão do Datasus demonstram um baixo perfil de demanda desse produto dispensado pelo Sistema Único de Saúde (SUS), com uma heterogeneidade na distribuição da TB nos estados brasileiros. Esse quadro parece se configurar principalmente por falta de uma política pública devidamente planejada, como a falta de unificação e normatização dos centros de distribuição, pela falta ou inadequação da remuneração do procedimento de aplicação da TB aos centros de tratamento, de modo padronizado pela tabela SUS e escassez de médicos capacitados para realizá-lo junto à falta de centros de reabilitação multidisciplinar habilitados. O uso de toxina botulínica com finalidade terapêutica no Brasil teve início nos anos 90, para tratamento de distonia e de espasticidade. Atualmente, é empregada em diferentes condições clínicas, porém, apesar da crescente demanda e indicações ao longo dos anos, há poucos relatos ou publicações sobre seu uso e benefício para pacientes atendidos pela Sistema Único de Saúde (SUS). Para abordar esse tema, em maio de 2015, na cidade de São Paulo, fisiatras de diferentes estados do Brasil se encontraram e discutiram a relevância da toxina botulínica no tratamento de espasticidade

The physiatrists specialized in treating spasticity were brought together for a panel discussion about the use of botulinum toxin (BT) in the public system in different states of Brazil. The data analyzed during the discussion of Datasus demonstrate a low-demand profile of the product dispensed by the Unified Health System (SUS), with heterogeneity in the distribution of TB in the Brazilian states. This scenario seems to be set up mainly for lack of a properly planned public policy, such as lack of unification and standardization of distribution centers, the lack or inadequacy of TB compensation proceeding to treatment centers, in a standardized manner by SUS and shortage of trained doctors to do it together with the lack of qualified multidisciplinary rehabilitation centers. The use of botulinum toxin for therapeutic purposes in Brazil began in the 90s, to treat dystonia and spasticity. It is currently employed in different clinical conditions; however, despite growing demand and indications over the years, there are few reports or publications on its use and benefit to patients served by the Unified Health System (SUS). To address this issue, in May 2015, in São Paulo, physiatrists from different states of Brazil met and discussed the relevance of botulinum toxin in treating spasticity

Experience with botulinum toxin therapy for axillary hyperhidrosis and comparison to modelled data for endoscopic thoracic sympathectomy - A quality of life and cost effectiveness analysis.

AIM: To estimate cost-effectiveness of botulinum toxin therapy for axillary hyperhidrosis compared to the standard surgical intervention of endoscopic thoracic sympathectomy (ETS). METHODS: The validated dermatology life quality index questionnaire was given to patients attending for treatment over a 4 month period, to assess their quality of life (QoL) over the preceding week (n = 44). Follow-up was performed 4-6 weeks later by telephone using the same questionnaire to validate the effectiveness of the treatment. The duration of effect of the botulinum toxin treatment was also recorded and this data was used as the basis for cost effectiveness analysis. Using HIPE data, the baseline cost for single intervention using botulinum toxin and ETS was retrieved. Using figures provided by HIPE and expert opinion of the costs of complications, a stochastic model for 10,000 patients was used to evaluate the total costs for ETS including the complications. RESULTS: The results from the QoL analysis show that botulinum toxin therapy is a successful therapy for improvement of symptoms. It was revealed that the mean interval before recurrence of original symptoms after botulinum toxin therapy was 5.6 months. The baseline cost for both treatments are €389 for botulinum toxin and €9389 for uncomplicated ETS. The stochastic model yields a mean cost of €11,390 for ETS including complications. CONCLUSIONS: Treatments reached cost equivalence after 13.3 years. However, given the efficacy of the botulinum toxin therapy and the low risk we propose that botulinum toxin therapy for hyperhidrosis should be considered the gold standard.

[Botulinum toxin therapy for spasticity].

Botulinum toxin (BTX) administered as an adjunct to other interventions for spasticity can act as a useful and effective therapeutic tool for treating patients disabled by spasticity. Presence of other non-reflex motor disorders (muscle stiffness, shortness, and contracture) can complicate the clinical course and disturb rehabilitative process of patients with spasticity. Treatment of spasticity using BTX can improve paralysis by correcting muscular imbalance that follows these diseases. In patients with chronic severe spasticity, we also have to address unique and difficult-to-treat clinical conditions such as abnormal posture and movement disorders. The effectiveness of BTX in treating some of these conditions is discussed. Because patients with neurological disabilities can show complex dysfunctions, specific functional limitations, goals, and expected outcomes of treatment should be evaluated and discussed with the patient, family members, and caregivers, prior to initiating BTX therapy. BTX therapy might improve not only care, passive function, but also motor functions in these patients by supplementing intensive rehabilitation with repetitive transcranial magnetic stimulation, transcranial direct-current stimulation, peripheral electrical stimulation, muscle stretching, and other rehabilitation strategies.

Cost considerations in the treatment of anal fissures.

Anal fissure is a split in the lining of the distal anal canal. Lateral internal sphincterotomy remains the gold standard for treatment of anal fissure. Although technique is simple and effective, a drawback of this surgical procedure is its potential to cause minor but some times permanent alteration in rectal continence. Conservative approaches (such as topical application of ointment or botulinum toxin injections) have been proposed in order to treat this condition without any risk of permanent injury of the internal anal sphincter. These treatments are effective in a large number of patients. Furthermore, with the ready availability of medical therapies to induce healing of anal fissure, the risk of a first-line surgical approach is difficult to justify. The conservative treatments have a lower cost than surgery. Moreover, evaluation of the actual costs of each therapeutic option is important especially in times of economic crisis and downsizing of health spending.

Continuation of long-term care for cervical dystonia at an academic movement disorders clinic.

Patients with cervical dystonia (CD) receive much of their care at university based hospital outpatient clinics. This study aimed to describe the clinical characteristics and treatment experiences of patients who continued care at our university based movement disorders clinic, and to document the reasons for which a subset discontinued care. Seventy patients (77% female) were recruited from all patients at the clinic (n = 323). Most (93%) were treated with botulinum neurotoxin (BoNT) injection, and onabotulinumtoxinA was initially used in 97%. The average dose of onabotulinumtoxinA was 270.4 U (range 50-500) and the median number of injections was 14 (range: 1-39). Twenty one patients later received at least one cycle of rimabotulinumtoxinB (33%); of those, 10 switched back to onabotulinumtoxinA (48%). The initial rimabotulinumtoxinB dose averaged 11,996 units (range: 3000-25,000 over 1-18 injections). Twenty one patients (30%) discontinued care. Reasons cited included suboptimal response to BoNT therapy (62%), excessive cost (24%), excessive travel burden (10%), and side effects of BoNT therapy (10%). Most patients (76%) did not seek further care after leaving the clinic. Patients who terminated care received fewer treatment cycles (5.5 vs. 13.0, p = 0.020). There were no other identifiable differences between groups in gender, age, disease characteristics, toxin dose, or toxin formulation. These results indicate that a significant number of CD patients discontinue care due to addressable barriers to access, including cost and travel burden, and that when leaving specialty care, patients often discontinue treatment altogether. These data highlight the need for new initiatives to reduce out-of-pocket costs, as well as training for community physicians on neurotoxin injection in order to lessen the travel burden patients must accept in order to receive standard-of-care treatments.

Comparative assessment of therapeutic response to physiotherapy with or without botulinum toxin injection using diffusion tensor tractography and clinical scores in term diplegic cerebral palsy children.

The present study was to compare the effects of combined therapy [botulinum (BTX) plus physiotherapy] with physiotherapy alone using diffusion tensor imaging (DTI) derived fractional anisotropy (FA) values of motor and sensory fiber bundles and clinical grade of the disability to see the value of BTX in term children with spastic diplegic cerebral palsy (CP). Clinically diagnosed 36 children participated in the study. All these children were born at term, and had no history of seizures. The study was randomly categorized into two groups: group I (n=18) - physiotherapy alone and group II (n=18) - physiotherapy plus BTX injection. Quantitative diffusion tensor tractography on all these children was performed on motor and sensory fiber bundles on baseline as well as after 6months of therapy. Motor function and clinical grades were also measured by gross motor function measures (GMFM) scale on both occasions. We observed significant change in FA value in motor and sensory fiber bundle as well as in GMFM scores at 6months compared to baseline study in both the groups. However, delta change and relative delta change in FA values of sensory and motor fiber bundle as well as GMFM score between group I and group II was statistically insignificant. We conclude that addition of BTX to physiotherapy regimen does not influence the outcome at 6months with similar insult in children with term diplegic spastic CP. This information may influence management of diplegic CP especially in developing countries, where BTX is beyond the reach of these children.

[Endoscopic treatment of obesity]. / Tratamiento endoscópico de la obesidad.

Obesity is highly prevalent in many developed and developing countries and is on the increase. The range of obese patients suitable for endoscopic treatment may be very broad. The most widely applied treatment in Spain and elsewhere in Europe is the Allergan intragastric balloon. The effectiveness of this technique is good in the short-term but suboptimal in the long term and its safety profile is high. However, severe complications may occur and consequently the indication and implantation of this technique should not be trivialized. In addition, there are distinct endoscopic devices that help patients lose weight, through distinct mechanisms of action, but these devices are currently under technological development and awaiting scientific validation. It is too soon to recommend these techniques and they should only be evaluated in the context of clinical trials.

Assessing competency in spasticity management: a method of development and assessment.

This project endeavored to create an educational module including methodology to instruct physical medicine and rehabilitation residents in the evaluation and appropriate treatment of patients with spasticity and other sequelae of the upper motor neuron syndrome. It further sought to verify acquired competencies in spasticity management through objective evaluation methodology. A physical medicine and rehabilitation board-certified physician with 10 yrs clinical experience in spasticity management trained 16 residents using a standardized competency-based module. Assessment tools developed for this program address the basic competencies outlined by the Accreditation Council for Graduate Medical Education. The 16 residents successfully demonstrated proficiency in every segment of the evaluation module by the end of the Postgraduate Year 3 spasticity management rotation. Objective measures compared resident scores on an institution-specific standardized test administered before and after training. Resident proficiency in the skills and knowledge pertaining to spasticity management was objectively verified after completion of the standardized educational module. Validation of the assessment tool is evidenced by significantly improved postrotational institution-specific standardized test scores (mean pretest score, 61.1%; mean posttest score, 95.4%) as well as oral testing. In addition, the clinical development tool was validated by residents being individually observed performing skills and deemed competent by a board-certified physical medicine and rehabilitation physician specializing in spasticity management. The standardized educational module and evaluation methodology provide a potential framework for the definition of baseline competency in the clinical skill area of spasticity management.

The point-touch technique for botulinum toxin injection in adductor spasmodic dysphonia: quality of life assessment.

BACKGROUND: Botulinum toxin injection under electromyographic guidance is the 'gold standard' for adductor spasmodic dysphonia treatment. The point-touch technique, an alternative injection method which relies on anatomical landmarks, is cheaper, quicker and more accessible, but has not yet gained widespread acceptance due to concerns about patient satisfaction. OBJECTIVE: To assess swallowing and voice-related quality of life following point-touch botulinum toxin injection in adductor spasmodic dysphonia patients. SETTING: Stanford University Voice and Swallowing Center. DESIGN: Prospective case series (evidence level four). METHODS: Consecutive adductor spasmodic dysphonia patients with a stable botulinum toxin dose-response relationship were recruited prospectively. The Eating Assessment Tool and Voice-Related Quality of Life questionnaires were completed pre-treatment and at 10 and 30 per cent completion of the injection cycle, respectively. RESULTS: Thirty-seven patients completed follow up. The mean total botulinum toxin dose was 0.88 units. Pre-treatment Voice-Related Quality of Life questionnaire results reflected the burden of disease. Post-treatment Eating Assessment Tool and Voice-Related Quality of Life questionnaire results were collected at 2.53 and 7.84 weeks, respectively; the former showed an increase in dysphagia, albeit statistically insignificant, while the latter showed significantly improved scores (both domain and total). CONCLUSION: The point-touch technique is a viable alternative for botulinum toxin injection in the treatment of adductor spasmodic dysphonia.

Botulinum toxin assessment, intervention and after-care for lower limb spasticity in children with cerebral palsy: international consensus statement.

Botulinum neurotoxin type-A (BoNT-A) has been used in association with other interventions in the management of spasticity in children with cerebral palsy (CP) for almost two decades. This consensus statement is based on an extensive review of the literature by an invited international committee. The use of BoNT-A in the lower limbs of children with spasticity caused by CP is reported using the American Academy of Neurology Classification of Evidence for therapeutic intervention. Randomized clinical trials have been grouped into five areas of management, and the outcomes are presented as treatment recommendations. The assessment of children with CP and evaluation of outcomes following injection of BoNT-A are complex, and therefore, a range of measures and the involvement of a multidisciplinary team is recommended. The committee concludes that injection of BoNT-A in children with CP is generally safe although systemic adverse events may occur, especially in children with more physical limitations (GMFCS V). The recommended dose levels are intermediate between previous consensus statements. The committee further concludes that injection of BoNT-A is effective in the management of lower limb spasticity in children with CP, and when combined with physiotherapy and the use of orthoses, these interventions may improve gait and goal attainment.

Botulinum toxin assessment, intervention and follow-up for paediatric upper limb hypertonicity: international consensus statement.

The primary objective of this paper was to evaluate the published evidence of efficacy and safety of botulinum neurotoxin (BoNT) injections in paediatric upper limb hypertonia (PULH). Secondary objectives included the provision of clinical context, based on evidence and expert opinion, in the areas of assessment, child and muscle selection, dosing, and adjunctive treatment. A multidisciplinary panel of authors systematically reviewed, abstracted, and classified relevant literature. Recommendations were based on the American Academy of Neurology (AAN) evidence classification. Following a literature search, 186 potential articles were screened for inclusion, and 15 of these met the criteria and were reviewed. Grade A evidence was found to support the use of BoNT to reach individualized therapeutic goals for PULH. There is grade B evidence (probably effective) for tone reduction following BoNT injections and grade U evidence (inconclusive) for improvement in upper limb (UL) activity and function. BoNT injections were generally found to be safe and well tolerated with the most common side effect identified as a transient decrease in grip strength.

Botulinum toxin assessment, intervention and aftercare for cervical dystonia and other causes of hypertonia of the neck: international consensus statement.

Dystonia in the neck region can be safely and effectively reduced with injections of Botulinum neurotoxin-A and B. People with idiopathic cervical dystonia have been studied the most. Benefits following injection include increased range of movement at the neck for head turning, decreased pain, and increased functional capacity (Class I evidence, level A recommendation). The evidence for efficacy and safety in patients with secondary dystonia in the neck is unclear based on the lack of rigorous research conducted in this heterogeneous population (level U recommendation). Psychometrically sound assessments and outcome measures exist to guide decision-making (Class I evidence, level A recommendation). Much less is known about the effectiveness of therapy to augment the effects of the injection (Class IV, level U recommendation). More research is needed to answer questions about safety and efficacy in secondary spastic neck dystonia, effective adjunctive therapy, dosing and favourable injection techniques.

Long-term management of strabismus with multiple repeated injections of botulinum toxin.

BACKGROUND: In the healthcare system in the United Kingdom, a number of patients may be offered botulinum toxin as an alternative to surgery in the treatment of their strabismus. We report on our experience of treating those who have received 25 or more injections. METHODS: A retrospective review of the botulinum toxin clinic database was used to identify patients who underwent 25 or more injections between November 1982 and January 2006. All patients with strabismus who met this criterion were included. A statistical analysis was performed in which we compared aspects of this group with those who had received 24 or fewer injections. RESULTS: Fifty-seven patients (0.90%) fulfilled our criteria. There were 37 women and 20 men, with a mean age at first injection of 39 years (range, 15 to 80 years). The number of injections per patient ranged from 25 to 68 (mean, 34). The duration of treatment was between 3 and 22 years. The time interval between injections tended to increase in most patients and the angle tended to reduce. There was no statistical difference between the age at first injection, sex, site injected, diagnosis, and complication rate between the long-term group and the group that received 24 or fewer injections. The long-term group, however, had undergone more previous operations (p < or = 0.001) and had a lower degree of binocularity (p