Dataset Information

Efficacy of Repeated Botulinum Toxin Type A Injections for Spastic Equinus in Children with Cerebral Palsy-A Secondary Analysis of the Randomized Clinical Trial.

ABSTRACT: Botulinum toxin A is considered an important tool to control spasticity in children with cerebral palsy. Several factors are known to affect the efficacy of botulinum toxin, such as dosage, appropriate muscle selection and application, age, and accompanying therapy. A multicenter, double-blind, randomized, prospective phase III clinical trial of botulinum toxin A for the treatment of dynamic equinus in 144 children with cerebral palsy was performed to compare the efficacies of letibotulinumtoxin A and onabotulinumtoxin A. Secondary analyses were performed to evaluate factors that affected the outcome, focusing on the number of times injections were repeated. Effectiveness was defined as a change of 2 or more in the physician's rating scale. Multivariate regression analyses were performed with multiple variables. The first injection of botulinum toxin A significantly improved D subscale of Gross Motor Function Measure-88 scores at 3 months compared to repeated injections (p < 0.05). After 6 months, patients who had one injection or none before the study showed significantly better outcomes than those who had more than one injection in terms of observational gait scores.

SUBMITTER: Hong BY

PROVIDER: S-EPMC5577587 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Efficacy of Repeated Botulinum Toxin Type A Injections for Spastic Equinus in Children with Cerebral Palsy-A Secondary Analysis of the Randomized Clinical Trial.

Hong Bo Young BY Chang Hyun Jung HJ Lee Sang-Jee SJ Lee Soyoung S Park Joo Hyun JH Kwon Jeong-Yi JY

Toxins 20170821 8

Botulinum toxin A is considered an important tool to control spasticity in children with cerebral palsy. Several factors are known to affect the efficacy of botulinum toxin, such as dosage, appropriate muscle selection and application, age, and accompanying therapy. A multicenter, double-blind, randomized, prospective phase III clinical trial of botulinum toxin A for the treatment of dynamic equinus in 144 children with cerebral palsy was performed to compare the efficacies of letibotulinumtoxin ...[more]

PMID: 28825663

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Project description:ObjectiveTo investigate the practice patterns of Canadian physicians who use perioperative botulinum toxin (BoNT) injections to improve surgical outcomes on spastic limbs.DesignA cross-sectional national survey composed of an invitation email and an 18-item questionnaire was disseminated by a national physical medicine and rehabilitation (PMR) society to 138 physician members involved in spasticity management.SettingNot applicable.ParticipantsTwenty-five percent of the participants (N=34) fully completed the survey.InterventionsNot applicable.Main outcome measuresParticipants completed an online questionnaire that examined the practice patterns and surgical outcomes associated with perioperative BoNT injections.ResultsThe majority (n=21; 84%) of Canadian physicians who inject BoNT perioperatively to improve outcomes of surgeries performed on spastic limbs are specialists in PMR practicing in academic settings. Most respondents (74%) used BoNT injections for perioperative treatment for patients with limb spasticity undergoing surgery. Of those surveyed, 65% of physicians used BoNT preoperatively, 21% used BoNT intraoperatively, and 24% used BoNT postoperatively.Of the physicians who performed BoNT injections preoperatively, 6% performed BoNT injections 7 to 12 weeks preoperatively, 32% performed BoNT injections 4 to 6 weeks preoperatively, 47% performed BoNT injections 2 to 3 weeks preoperatively, and 15% performed BoNT injections 0 to 1 week preoperatively. The majority of physicians (85%) responded that injecting BoNT perioperatively may improve a patient's surgical outcome and all of the participants (100%) stated that BoNT did not contribute to any perioperative complications or adverse effects. Qualitative responses emphasized that successful outcomes from the perioperative BoNT were linked to enhanced collaboration with surgeons and that more research is needed to determine the optimal timing of perioperative BoNT.ConclusionCanadian physicians, mostly PMR specialists, administer perioperative BoNT to improve outcomes of surgeries performed on spastic limbs. The optimal timing for perioperative BoNT was suggested to be 2 to 3 weeks before the surgery by 47% of survey respondents. All participating physicians responded that perioperative BoNT did not contribute to any known perioperative complications or adverse events. This study highlights the importance of conducting more robust research to better understand optimal timing for perioperative BoNT injection, enhancing collaboration between physicians and surgeons, and increasing awareness of perioperative BoNT when planning for surgeries on spastic limbs.

Project description:Repeated injection cycles with abobotulinumtoxinA, a botulinum toxin type A, are recommended in current clinical guidelines as a treatment option for adults with upper limb spastic paresis. However, the magnitude of the maximal therapeutic effect of repeated abobotulinumtoxinA treatment across different efficacy parameters and the number of injection cycles required to reach maximal effect remain to be elucidated. Here, we present a post hoc exploratory analysis of a randomized, double-blind, placebo-controlled trial (12-24?weeks; NCT01313299) and open-label extension study (up to 12?months; NCT0131331), in patients aged 18-80?years with hemiparesis for ?6?months after stroke/traumatic brain injury. Two inferential methods were used to assess the changes in efficacy parameters after repeat abobotulinumtoxinA treatment cycles: Mixed Model Repeated Measures analysis and Non-Linear Random Coefficients analysis. Using the latter model, the expected maximal effect size (not placebo-controlled) and the number of treatment cycles to reach 90% of this maximal effect were estimated. Treatment responses in terms of passive and perceived parameters (i.e. modified Ashworth scale in primary target muscle group, disability assessment scale for principal target for treatment or limb position, and angle of catch at fast speed) were estimated to reach near-maximal effect in two to three cycles. Near-maximal treatment effect for active parameters (i.e. active range of motion against the resistance of extrinsic finger flexors and active function, assessed by the Modified Frenchay Scale) was estimated to be reached one to two cycles later. In contrast to most parameters, active function showed greater improvements at Week 12 (estimated maximal change from baseline-modified Frenchay Scale overall score: +0.8 (95% confidence interval, 0.6; 1.0) than at Week 4 (+0.6 [95% confidence interval, 0.4; 0.8]). Overall, the analyses suggest that repeated treatment cycles with abobotulinumtoxinA in patients chronically affected with upper limb spastic paresis allow them to relearn how to use the affected arm with now looser antagonists. Future studies should assess active parameters as primary outcome measures over repeated treatment cycles, and assess efficacy at the 12-week time-point of each cycle, as the benefits of abobotulinumtoxinA may be underestimated in the studies of insufficient duration. Abbreviated summary In this post hoc analysis of repeated abobotulinumtoxinA injection cycles in upper limb spastic paresis, Gracies et al. used statistical modelling to elucidate the maximal therapeutic effect of abobotulinumtoxinA. Notably, the number of injections required to reach this maximal effect was higher for active (e.g. active function) compared with passive (e.g. tone) parameters.

Dataset Information

Efficacy of Repeated Botulinum Toxin Type A Injections for Spastic Equinus in Children with Cerebral Palsy-A Secondary Analysis of the Randomized Clinical Trial.

Publications

Efficacy of Repeated Botulinum Toxin Type A Injections for Spastic Equinus in Children with Cerebral Palsy-A Secondary Analysis of the Randomized Clinical Trial.

Similar Datasets

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