Botulinum Toxin Type A Neuromuscular Blockade in the Treatment of Lower Extremity Spasticity in Cerebral Palsy: A Randomized, Double-Blind, Placebo-Controlled Trial

Koman, L. Andrew; Mooney, James F.; Smith, Beth Paterson; Walker, Francis O.; Leon, Judith M.

doi:10.1097/01241398-200001000-00022

Cited by 212 publications

(249 citation statements)

References 15 publications

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“…1 Chemodenervation with BoNTA has important clinical uses in the management of neuromuscular disorders including achalasia, hyperhydrosis, and spasticity and an emerging role as tendon bioprotection. [2][3][4][5][6] Although many clinicians administer BoNTA injections, little consensus exists regarding the appropriate injection dose and volume. 2,7,8 Clinical preparations for BoNTA intramuscular injection are most commonly in concentrations of 50 and 100 U/ml with an injection volume of 2-4 ml, but may be as concentrated as 500 U/ml and injected in volumes of up to 8 ml.…”

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confidence: 99%

Dose‐ and volume dependent‐response to intramuscular injection of botulinum neurotoxin‐A optimizes muscle force decrement in mice

Stone

Callahan

et al. 2011

Journal Orthopaedic Research

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Botulinum neurotoxin-A (BoNTA) is a potent neurotoxin used to alter muscle tone to manage spasticity and to provide tendon bioprotection; however, the appropriate dose and injection volume to administer is not defined. Male mice (n ¼ 120) received BoNTA injections into one gastrocnemius with either a constant volume (10 ml) with a variable dose (1, 3, 6 U/kg) or a constant dose (3 U/kg) in a variable volume (2.5, 5, 10, 20, 30 ml). Electromyographic (EMG) examination, muscle force generation (MFG), and wet muscle mass were measured in the ipsilateral and contralateral limbs at 1, 2, 4, or 12 weeks post-injection. MFG and EMG responses decreased to approximately 40% of contralateral after a 1 U/kg injection and 0% of contralateral by 3 and 6 U/kg injection at 1 week after injection. Neuromuscular blockade was greatest with a 10 ml injection volume. MFG, EMG examination, and wet muscle mass reached contralateral values 12 weeks after injection for all injection doses and volumes tested. Effective injection doses and volumes were identified for producing full and partial neuromuscular blockade in the mouse gastrocnemius. These findings have important clinical implications in the intramuscular administration of BoNTA to manage muscle tone. ß

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confidence: 99%

Dose‐ and volume dependent‐response to intramuscular injection of botulinum neurotoxin‐A optimizes muscle force decrement in mice

Stone

Callahan

et al. 2011

Journal Orthopaedic Research

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“…Botulinum toxin A (BoNT/A), a practical neuromuscular blocking agent that causes a clinical reduction in spasticity in working muscles, appears to have a beneficial effect on the natural history of CP patients with equinus deformity 6 . The objective of the present study was to evaluate the safety and effectiveness of BoNT/A in the treatment of children with spastic diplegic cerebral palsy.…”

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Botulinum toxin type A in the treatment of lower-limb spasticity in children with cerebral palsy

Camargo

Teive

Zonta

et al. 2009

Arq. Neuro-Psiquiatr.

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-We evaluated the safety and effectiveness of botulinum toxin A (BoNT/A) in the treatment of spasticity in 20 children with spastic diplegic cerebral palsy (CP). All the patients received injections in the gastrocnemius and soleus, and 15 received injections in the adductors. The total dose varied from 70 to 140 U (99.75±16.26 U), or 7.45±2.06 U/kg per patient. The treatment improved the patients' walking and gait pattern significantly. There was also a significant alteration in the heel-ground distance and increased motion of the ankle joint. These structural changes in the feet were sustained until the end of the follow-up, although the same was not observed for the functional parameters. Three patients complained of weakness in the lower limbs. In conclusion, BoNT/A is safe and effective when used in a single session of injections and produces a sustained structural modification of the lower limbs. However, functional changes are temporary and are only observed during the peak effect of the drug.Key Words: cerebral palsy, botulinum toxin, spasticity. Toxina botulínica tipo A como tratamento para espasticidade de membros inferiores em crianças com paralisia cerebralResumo -Para avaliação da segurança e eficácia do tratamento com toxina botulínica A (TB-A) na espasticidade na paralisia cerebral (PC), foram selecionadas 20 crianças com a forma diplegia espástica. Todos os pacientes receberam injeções nos gastrocnêmios e sóleos, 15 receberam doses nos adutores da coxa. A dose total variou de 70 a 140 Us (99,75±16,26 U), 7,45±2,06 U/Kg por paciente. o tratamento com a TB-A melhorou significativamente a deambulação e o padrão de marcha. Houve também significativa alteração da distância tornozelo-solo e aumento da amplitude de movimento da articulação do tornozelo. essas mudanças estruturais dos pés se mantiveram até o final do acompanhamento. o mesmo não foi observado com parâmetros funcionais. Três pacientes apresentaram fraqueza em membros inferiores. Conclui-se que a TB-A, em uma única aplicação, é segura e eficaz. Há modificação sustentada da estrutura motora dos membros inferiores, porém mudanças funcionais são temporárias, durante o pico de ação do medicamento.PAlAvrAs-CHAve: paralisia cerebral, espasticidade, toxina botulínica.

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“…In a number of controlled studies, beneficial effects of toxin treatment, over and above the placebo effects, have been reported for lowerlimb spasticity associated with CP (Chutorian and Root 1995;Corry et al 1997Corry et al , 1999Sutherland et al 1999;Koman et al 2000). In addition, the beneficial effect of BTX-A has been demonstrated when compared with splinting and stretching casts (Corry et al 1998, Flett et al 1999.…”

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confidence: 93%

“…However, in most studies in children with CP, injections have been made into the gastrocnemius muscle (Koman et al 1993(Koman et al , 1994Cosgrove et al 1994;Chutorian and Root 1995;Corry et al 1998;Flett et al 1999;Eames et al 1999;Sutherland et al 1999;Boyd et al 2000;Koman et al 2000).…”

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confidence: 99%

Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double‐blind, placebo‐controlled, dose‐ranging study

Baker

Jasiński

Maciąg-Tymecka³

et al. 2002

Develop Med Child Neuro

121

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This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX‐A; Dysport) in 125 patients (mean age 5.2 years, SD 2; 54% male)with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 1920, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.

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Botulinum Toxin Type A Neuromuscular Blockade in the Treatment of Lower Extremity Spasticity in Cerebral Palsy: A Randomized, Double-Blind, Placebo-Controlled Trial

Cited by 212 publications

References 15 publications

Dose‐ and volume dependent‐response to intramuscular injection of botulinum neurotoxin‐A optimizes muscle force decrement in mice

Dose‐ and volume dependent‐response to intramuscular injection of botulinum neurotoxin‐A optimizes muscle force decrement in mice

Botulinum toxin type A in the treatment of lower-limb spasticity in children with cerebral palsy

Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double‐blind, placebo‐controlled, dose‐ranging study

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