Parent Evaluation of Spasticity Treatment in Cerebral Palsy Using Botulinum Toxin Type A

doi:10.1016/j.apmr.2006.08.343

Archives of Physical Medicine and Rehabilitation

Volume 87, Issue 12, December 2006, Pages 1658-1660

https://doi.org/10.1016/j.apmr.2006.08.343 Get rights and content

Abstract

Symons FJ, Rivard PF, Nugent AC, Tervo RC. Parent evaluation of spasticity treatment in cerebral palsy using botulinum toxin type A.

Objective

To assess parent ratings of treatment acceptability associated with botulinum toxin type A (BTX-A) injection for spasticity in children with cerebral palsy (CP).

Design

A single-point survey design across a sequentially recruited cohort, using a standardized evaluation measure.

Setting

Regional specialty health care center medical clinic and pain research program.

Participants

Fifty-nine parents of children with CP receiving BTX-A injection for spasticity.

Interventions

Not applicable.

Main Outcome Measure

The Treatment Evaluation Inventory.

Results

Overall, parent ratings of treatment acceptability ranged from moderate to high. There were no significant differences for caregiver ratings in relation to characteristics of the raters (age, sex, marital status) or of the children (age, sex, mental retardation, severity of disability) characteristics.

Conclusions

These findings indicate that on average, parents of children with CP consider BTX-A treatment for the management of spasticity to be an acceptable form of treatment.

Section snippets

Participants and Setting

After receiving institutional review board approval for the study, we formed a convenience sample. Sixty-five consecutive care providers (eg, parents, foster parents) who brought their children for BTX-A injections to an outpatient, hospital-based clinic of a large regional children’s specialty health care center in Minneapolis were asked to complete a treatment evaluation survey. On checking in, care providers were given the survey and asked to complete it before the clinic appointment began.

Results

Sixty surveys were returned (92%) and 59 (98%) were retained (1 survey was not completed correctly). Forty-three (74%) were completed by female respondents (79% biologic mothers) from 2 parent households (80%). The mean age of all respondents ± standard deviation (SD), was 41.5±9.2 years (range, 22.9−69.5y). The patients ranged in age from 10.8 months to 39 years (mean, 10.9y) and 38 (64%) were boys. Twenty-two percent (n=13) of the respondents characterized their child’s disability as mild,

Discussion

Our main purpose in this preliminary survey was to evaluate parental report of the acceptability of BTX-A treatment for their child’s spasticity, and to evaluate whether treatment acceptability ratings varied in relation to parent or child demographics. Overall, there were moderate to high levels of satisfaction reported and no significant differences were found for raters in regard to age of parent rater or child, sex of parent rater or child, marital status of parent rater, severity of

Conclusions

The value of evaluating treatment procedures and outcomes from different perspectives is underscored by increasing emphasis on measures that complement but go beyond traditional clinical efficacy endpoints.⁵ One reason for this is a need to understand the factors that influence whether patients and their families adhere to treatments. A treatment may be efficacious but have little impact if it is not followed or implemented. In this study, the TEI provided preliminary evidence that parents

References (10)

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Botulinum toxin type A neuromuscular blockage in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trialBOTOX Study Group
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Management of spasticity associated pain with botulinum toxin A
J Pain Sympt Manage
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Botulinum toxin treatment of spastic equinus in cerebral palsy: a randomized trial comparing two injection sites
Am J Phys Med Rehabil
(2005)
M.L. McCarthy et al.
The Pediatric Quality of Life Inventory: an evaluation of its reliability and validity for children with traumatic brain injury
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M.E. Gormley et al.
Use of botulinum toxin type A in pediatric patients with cerebral palsy: a three-center retrospective chart review
J Child Neurol
(2001)

There are more references available in the full text version of this article.

Cited by (11)

Sedation-analgesia protocol for the injection of botulinum toxin A in cerebral palsy
2019, Anales de Pediatria
Evaluar el impacto de la técnica sedoanalgésica en el dolor experimentado por el paciente.
Estudio transversal realizado en pacientes consecutivos con parálisis cerebral (PC) que se infiltraron con toxina botulínica A (OnabotA). Los pacientes fueron divididos en 4 grupos según la estrategia analgésica asignada: Grupo I, sin sedación o crema anestésica tópica; Grupo II, inhalación de óxido nitroso; Grupo III, sedación intravenosa profunda y Grupo IV, sedación ligera con benzodiacepinas. El dolor se evaluó con diferentes escalas según la edad del paciente. Los padres clasificaron su satisfacción con la comodidad de su hijo mediante una escala tipo Likert de 5 puntos. La variable primaria de eficacia fue la proporción de pacientes que experimentaron un nivel de dolor ≤ 2, según las escalas de dolor, en los diferentes grupos de estudio.
De los 124 pacientes incluidos en el estudio, 56 (45,2%) experimentaron un nivel de dolor ≤ 2. En el Grupo III, una proporción significativamente mayor de pacientes presentó un nivel de dolor ≤ 2, p < 0,001, en comparación con todos los grupos de estudio, respectivamente. La inyección de OnabotA fue guiada por ultrasonografía en 109 (87,9%) pacientes y por referencia anatómica en 15 (12,1%).
En los pacientes con PC tratados con infiltraciones de OnabotA, la estrategia sedoanalgésica tuvo un impacto significativo en el dolor experimentado por el sujeto. Seleccionar una estrategia analgésica apropiada es crucial para reducir el estrés asociado con la administración de inyecciones de OnabotA en niños con PC.
To evaluate the impact of the sedation-analgesia technique on the pain experienced by the patient.
This cross-sectional study was conducted on consecutive patients with cerebral palsy (CP) who underwent infiltration with botulinum toxin A (BoTNA). The patients were divided into 4 different groups according to the analgesic strategy assigned: Group I, without sedation or topical anaesthetic cream; Group II, inhalation of nitrous oxide; Group III, deep intravenous sedation; and Group IV, light sedation with benzodiazepines. Pain was assessed with different scales depending on patient age. Parents were asked to rate their satisfaction with their child's comfort by using a 5-point Likert-type scale. The primary end-point was the proportion of patients that experienced a pain level equal or lower than 2, according to pain scales, in the different study groups.
Of the 124 patients included in the study, 56 (45.2%) experienced a pain level ≤ 2. In the Group III a significantly greater proportion of patients were classified with a pain level score ≤ 2, P < .001, as compared with all the study groups, respectively. The BoTNA injection was guided by ultrasonography in 109 (87.9%) patients, and by palpation in 15 (12.1%).
The results of this study suggested that, in patients with CP treated with BoTNA injections, the sedation-analgesic strategy had a significant impact on the pain experienced by the subject. Selecting an appropriate analgesic strategy is crucial for reducing the stress associated with the administration of BoTNA injections in children with CP.
Systematic review of the effectiveness of physiotherapy plus type A botulimun toxin in reducing lower limb spasticity in children with cerebral palsy
2016, Rehabilitacion
La parálisis cerebral es una lesión no progresiva del sistema nervioso central que origina, entre otros posibles síntomas, un tono muscular patológico. La espasticidad es muy frecuente y conlleva limitaciones en las actividades de la vida diaria. Aunque existen multitud de tratamientos físicos y farmacológicos para este alterado tono muscular, su eficacia está muy discutida, ya que los resultados son muy dispares de un individuo a otro.
El objetivo del trabajo es realizar una revisión sistemática de la eficacia del tratamiento de la espasticidad de miembros inferiores, en cualquier tipo de parálisis cerebral infantil, mediante tratamiento fisioterápico junto con tratamiento farmacológico con toxina botulínica tipo A. Dicha eficacia se refiere a conseguir un aumento en el rango articular, una disminución en el tono muscular o una mejoría en la marcha, que se reflejarán en escalas de valoración específicas y en escalas de valoración de las actividades de la vida diaria. Los objetivos secundarios del trabajo son conocer los efectos adversos de la inyección de la toxina y la variabilidad de la duración de los efectos de esta.
Se realizó una búsqueda bibliográfica de artículos desde enero de 2006 hasta enero de 2013, ambos incluidos, en las siguientes bases de datos: Biblioteca Cochrane, Medline, CINAHL, ISI Web of Knowledge y PEDro. Se valoró la calidad de los estudios prospectivos y retrospectivos y de los ensayos clínicos con la Escala de Jadad (también llamada Sistema de Puntuación de Calidad de Oxford), y la de las revisiones sistemáticas con la Assessment of Multiple Systematic Reviews (herramienta de valoración de revisiones sistemáticas).
Se encontraron 14 artículos que cumplían los criterios de inclusión. Se observó, en 9 de ellos, una disminución en el tono muscular, un aumento del rango articular y una mejora en la función motora gruesa. Dichos resultados variaron de unos pacientes a otros debido, entre otras causas, a la edad (mejores resultados en pacientes menores de 6 años), la musculatura inyectada (mejores resultados en el tríceps sural), el uso de ecografía como guía para una mayor precisión de la inyección o el estado cognitivo del paciente.
Se observaron resultados estadísticamente significativos en la reducción del tono muscular a corto plazo en 12 de los estudios, detectándose el momento de mayor disminución aproximadamente a las 4-5 semanas postinyección. Sin embargo, a largo plazo (un año) solo en un estudio se mantenía esta disminución del tono muscular. El uso de multitud de escalas obstaculizó la posibilidad de comparar los resultados de la medición del tono muscular o la valoración de la función motora gruesa entre diferentes estudios. Por otro lado, algunos artículos dejan en un segundo plano las técnicas de rehabilitación utilizadas, su frecuencia y sus efectos, lo que ha dificultado saber en qué medida condicionaron la eficacia de la toxina. El tratamiento ortopédico se incluyó en 8 estudios y sus resultados coinciden en una ganancia mayor en la dorsiflexión de tobillo y en la función motora gruesa. La edad para comenzar el tratamiento con la toxina para que esta sea más eficaz está muy discutida: hay 5 estudios en los que se afirma que los menores de 6 años obtuvieron mejores resultados en la disminución del tono muscular, mientras que en otro estudio se asegura que la edad no es un factor concluyente. Para estudios futuros es importante incorporar el uso del ecógrafo durante la inyección, explicar las técnicas de rehabilitación aplicadas y su frecuencia, mejorar la calidad de los estudios con muestras de mayor tamaño y más homogéneas y utilizar las escalas más actualizadas y aceptadas.
El tratamiento combinado de fisioterapia y toxina botulínica tipo A disminuye el tono muscular, aumenta el rango articular de movimiento y mejora la función motora gruesa, lo que incluye mejoras en las transferencias y en la marcha, especialmente si se añade tratamiento ortopédico. Los pacientes presentaron tras la inyección un pico de mejora respecto al tono muscular aproximadamente al mes; sin embargo, dicho pico no se mantenía a largo plazo (un año), surgiendo de nuevo el tono patológico.
Cerebral palsy is the result of non-progressive damage to the central nervous system and causes, among other possible symptoms, pathological muscle tone. Spasticity is very common and leads to limitations in activities of daily living. There are many physical and drug therapies for this altered muscle tone but their effectiveness is widely debated because the results are very different from one individual to another.
The objective of this study was to conduct a systematic review of the effectiveness of treatment of lower limb spasticity in any type of cerebral palsy, using physiotherapeutic and drug treatment with type A botulinum toxin. This effectiveness refers to the achievement of an increase in joint range, a decrease in muscle tone or an improvement in gait that will be reflected in specific rating scales and assessment of scales of activities of daily living. Secondary objectives were to determine the adverse effects of botulinum toxin injection and variability in the duration of its effects.
A literature search was conducted of studies published from January 2006 to January 2013, inclusive, in the following databases: Cochrane Library, Medline, CINAHL, ISI Web of Knowledge and PEDro. The quality of the clinical trials as well as those of the prospective and retrospective studies was evaluated by the Jadad Scale (also known as the Oxford Quality Scale) and by the Assessment of Multiple Systematic Reviews measurement tool.
Fourteen articles met the inclusion criteria. Nine of these studies observed a decrease in muscle tone, an increase in joint range and an improvement in gross motor function. These results varied from one patient to another due to age (better results in patients younger than 6 years old), injected muscles (better results in the sural triceps), use of ultrasound-guided injection for greater injection accuracy, and the patient's cognitive status.
Statistically significant results were found in the short-term decrease of spasticity in 12 studies, the best moment being detected approximately between the 4th and 5th week after the injection. However, only one study reported that this decrease in muscle tone was maintained in the long term (one year). The use of a large number of different scales hampered comparison of the results of muscle tone measurement or gross motor function assessment in distinct studies. Some articles did not describe the frequency and effects of the implemented rehabilitation programme and therefore it was difficult to determine the extent of the influence of these factors on the effectiveness of botulinum toxin. Orthopaedic treatment was included in 8 studies, obtaining better results in ankle dorsiflexion and in gross motor function. There is wide debate on when botulinum toxin injections should be started to achieve maximal effectiveness; 5 studies claim better results in decreased muscle tone in children younger than 6 years, whereas another study asserts that age is not a conclusive factor. Future studies should incorporate the use of ultrasound during injection, explain the rehabilitation techniques applied and their frequency, include larger and more homogeneous samples to improve quality, and use the most updated and widely accepted scales.
Combined treatment with physiotherapy and type A botulinum toxin reduces muscle tone, increases joint range of motion and improves gross motor function, which includes enhanced transfers and gait, especially if orthopaedic treatment is added. Patients showed a peak improvement in muscle tone at approximately one month after the injection. However, this improvement was not maintained in the long term, with pathological muscle tone developing once again.
Visual Analogue Scale to score the effects of Botulinum Toxin A treatment in children with cerebral palsy in daily clinical practice
2008, European Journal of Paediatric Neurology
Citation Excerpt :
Several studies have shown the benefits of intramuscular Botulinum Toxin Type A (BTX-A) injections for the management of spasticity in children with CP.3–5 Studies indicate that parents of children with CP consider BTX-A treatment to be an acceptable form of treatment.6 BTX-A inhibits cholinergic transmission at neuromuscular synapses and relaxes muscles.
This study examined the reliability and efficiacy of the Visual Analogue Scale (VAS) in evaluating spasticity treatment in an outpatient setting.
We used a parent-reported VAS device for evaluating the effects of Botulinum Toxin A (BTX-A). Data were collected on 55 children with cerebral palsy. Individual goals of treatment were formulated in close consultation with the caregivers. The categories of treatment options were improvement of pain, problems with nursing, sitting position, standing and walking.
Seventy-four interventions were performed in 55 children. A statistically significant effect was found for improvement of nursing, standing and walking. No statistically significant effect for pain was found, probably because of small numbers. In seven children there was no effect at all. Side effects were observed in five children.
In using a VAS instrument, beneficial effects were found for nursing, standing and walking after BTX-A treatment. A positive (not significant) correlation was found between the VAS and the Modified Tardieu for those children who also underwent a gait analysis. Evaluating spasticity treatment with the use of the VAS has an important advantage because it is a quick and easy method for evaluating individually defined treatment goals in an outpatient setting, in which time-consuming evaluations are not an option.
Parental Evaluation and Botulinum Toxin Type A
2007, Archives of Physical Medicine and Rehabilitation
Can Biomarkers Differentiate Pain and No Pain Subgroups of Nonverbal Children with Cerebral Palsy? A Preliminary Investigation Based on Noninvasive Saliva Sampling
2015, Pain Medicine (United States)
Citation Excerpt :
This may be because biochemical factors, which are undetectable by imaging, are contributing to a chronic pain state. Because of problems related to self-report and cognitive, motor, and sensory impairments, adequate pain management often eludes individuals with neurodevelopmental disabilities [7]. Therapeutic decisions are frequently based on trial and error, creating a situation frustrating to physicians and nurses as well as individual patients and their families.
Assessing and treating pain in nonverbal children with developmental disabilities are a clinical challenge. Current assessment approaches rely on clinical impression and behavioral rating scales completed by proxy report. Given the growing health relevance of the salivary metabolome, we undertook a translational-oriented feasibility study using proton nuclear magnetic resonance (NMR) spectroscopy and neuropeptide/cytokine/hormone detection to compare a set of salivary biomarkers relevant to nociception.
Within-group observational design.
Tertiary pediatric rehabilitation hospital.
Ten nonverbal pediatric patients with cerebral palsy with and without pain.
Unstimulated (passively collected) saliva was collected using oral swabs followed by perchloric acid extraction and analyzed on a Bruker Avance 700 MHz NMR spectrometer. We also measured salivary levels of several cytokines, chemokines, hormones, and neuropeptides.
Partial least squares discriminant analysis showed separation of those children with/without pain for a number of different biomarkers. The majority of the salivary metabolite, neuropeptide, cytokine, and hormone levels were higher in children with pain vs no pain.
The ease of collection and noninvasive manner in which the samples were collected and analyzed support the possibility of the regular predictive use of this novel biomarker-monitoring method in clinical practice.
Gender differences in treatments and interventions received by children and adolescents with cerebral palsy
2020, BMC Pediatrics

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Supported in part by a McKnight Land-Grant Professorship.

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Brief reportParent Evaluation of Spasticity Treatment in Cerebral Palsy Using Botulinum Toxin Type A

Abstract

Objective

Design

Setting

Participants

Interventions

Main Outcome Measure

Results

Conclusions

Section snippets

Participants and Setting

Results

Discussion

Conclusions

Botulinum toxin type A neuromuscular blockage in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trialBOTOX Study Group

J Pediatr Orthop

Management of spasticity associated pain with botulinum toxin A

J Pain Sympt Manage

Botulinum toxin treatment of spastic equinus in cerebral palsy: a randomized trial comparing two injection sites

Am J Phys Med Rehabil

The Pediatric Quality of Life Inventory: an evaluation of its reliability and validity for children with traumatic brain injury

Arch Phys Med Rehabil

Use of botulinum toxin type A in pediatric patients with cerebral palsy: a three-center retrospective chart review

J Child Neurol

Brief report
Parent Evaluation of Spasticity Treatment in Cerebral Palsy Using Botulinum Toxin Type A