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The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

ABSTRACT: Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ?1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ?1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.

SUBMITTER: Khan P

PROVIDER: S-EPMC7762077 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Khan Patricia P Riberto Marcelo M Frances João Amaury JA Chueire Regina R Amorim Ana Cristina Ferreira Garcia ACFG Xerez Denise D Chung Tae Mo TM Mercuri Lucia Helena Costa LHC Longo Alexandre Luiz AL Lianza Sérgio S Maisonobe Pascal P Ruiz-Schutz Viviane C VC

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Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients rece ...[more]

PMID: 33291807

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Project description:BackgroundThe anti-spasticity efficacy of botulinum toxin (BoNT) injection has been well established for patients with chronic stroke; however, extracorporeal shock wave therapy (ESWT), i.e. focused shockwave (FSW) and radial shockwave (RSW), has recently been applied. We aimed to investigate the comparative effectiveness of BoNT vs. ESWT in the reduction of spasticity among stroke survivors.MethodsPubMed, EMBASE, MEDLINE and Cochrane CENTRAL were searched from the earliest record to September 2021 for randomized controlled trials. Weighted mean differences (WMDs) on the reduction of the Modified Ashworth Scale before or at the 6th post-treatment week (short-term) and between the 7th and 12th weeks (mid-term) after the intervention were calculated. Ranking probabilities of the WMD were simulated to determine which treatment had the potential to possess the best effectiveness. inplasy.com registration: INPLASY202170018.FindingsA total of 33 studies comprising 1,930 patients were enrolled. The network meta-analysis revealed that BoNT injections, FSW and RSW were better in spasticity reduction than the control treatment(s) at the short term, with WMDs of -0.69 (95% CI, -0.87 to -0.50), -0.36 (95% CI, -0.69 to -0.03) and -0.62 (95% CI, -0.84 to -0.40), respectively. Likewise, mid-term effects of BoNT injections, FSW and RSW also revealed superiority, with WMDs of -0.44 (95% CI, -0.62 to -0.26), -0.74 (95% CI, -1.26 to -0.23) and -0.79 (95% CI, -1.07 to -0.51), respectively. Ranking probability analysis revealed that RSW had the highest probability of being the best treatment for spasticity reduction at the short-term (62.2%) and mid-term (72.3%) periods during the follow up.InterpretationBoNT injections and ESWT are effective in alleviating post-stroke spasticity at the mid-term. The effectiveness of ESWT was comparable to BoNT injections, and RSW had the potential to be the best treatment for spasticity reduction among the three treatment options. More prospective trials incorporating head-to-head comparisons of BoNT injections vs. ESWT are needed to validate the role of ESWT in reducing post-stroke spasticity.FundingThe current research project was supported by (1) National Taiwan University Hospital, Bei-Hu Branch; (2) Ministry of Science and Technology (MOST 106-2314-B-002-180-MY3 and 109-2314-B-002-114-MY3); 3) Taiwan Society of Ultrasound in Medicine.

Project description:Background: The combined use of Robot-assisted UL training and Botulinum toxin (BoNT) appear to be a promising therapeutic synergism to improve UL function in chronic stroke patients. Objective: To evaluate the effects of Robot-assisted UL training on UL spasticity, function, muscle strength and the electromyographic UL muscles activity in chronic stroke patients treated with Botulinum toxin. Methods: This single-blind, randomized, controlled trial involved 32 chronic stroke outpatients with UL spastic hemiparesis. The experimental group (n = 16) received robot-assisted UL training and BoNT treatment. The control group (n = 16) received conventional treatment combined with BoNT treatment. Training protocols lasted for 5 weeks (45 min/session, two sessions/week). Before and after rehabilitation, a blinded rater evaluated patients. The primary outcome was the Modified Ashworth Scale (MAS). Secondary outcomes were the Fugl-Meyer Assessment Scale (FMA) and the Medical Research Council Scale (MRC). The electromyographic activity of 5 UL muscles during the "hand-to-mouth" task was explored only in the experimental group and 14 healthy age-matched controls using a surface Electromyography (EMGs). Results: No significant between-group differences on the MAS and FMA were measured. The experimental group reported significantly greater improvements on UL muscle strength (p = 0.004; Cohen's d = 0.49), shoulder abduction (p = 0.039; Cohen's d = 0.42), external rotation (p = 0.019; Cohen's d = 0.72), and elbow flexion (p = 0.043; Cohen's d = 1.15) than the control group. Preliminary observation of muscular activity showed a different enhancement of the biceps brachii activation after the robot-assisted training. Conclusions: Robot-assisted training is as effective as conventional training on muscle tone reduction when combined with Botulinum toxin in chronic stroke patients with UL spasticity. However, only the robot-assisted UL training contributed to improving muscle strength. The single-group analysis and the qualitative inspection of sEMG data performed in the experimental group showed improvement in the agonist muscles activity during the hand-to-mouth task. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03590314.

Project description:ObjectivesThe therapeutic effects of botulinum neurotoxin (BoNT) are well documented in upper limb spasticity. However, several factors may influence treatment efficacy, including targeting of neuromuscular junctions (NMJs). We examined whether NMJ-targeted BoNT injections were non-inferior, in terms of efficacy, to current injection practices.DesignOpen-label prospective evaluator-blinded study.SettingConducted across 20 medical centres in Denmark, Finland, Norway and Sweden (24 September 2012 to 11 March 2015).ParticipantsAged ˃18 years with upper limb spasticity (Modified Ashworth Scale [MAS] score of 2 or 3) following stroke or traumatic brain injury, had received ≥2 consecutive BoNT-A treatment cycles (the latest of which was abobotulinumtoxinA [aboBoNT-A]) and needed BoNT-A retreatment (same modality as previous cycle). Patients requiring aboBoNT-A doses >800units were excluded. In total, 88 patients were randomised (intention-to-treat [ITT] population), most were male (n=58/88, 65.9%) and 54/88 (61.4%) completed the study (per protocol [PP] population).InterventionsRandomisation (1:1) to receive a single dose of aboBoNT-A (≤800 U) according to either current clinical practice (300 U/mL) or as an NMJ-targeted injection (100 U/mL).Primary outcome measureProportion of patients with a ≥1 level reduction from baseline in MAS score at week 4 post-injection (responders).ResultsIn the ITT population, the proportion of responders at elbow flexors was 72.7% in the current practice group and 56.8% in the NMJ-targeted group (adjusted difference -0.1673 [95% CIs: -0.3630 to 0.0284]; p=0.0986). Similar results were observed in the PP population (69.0% vs 68.0%, respectively, adjusted difference 0.0707 [-0.1948 to 0.3362]; p=0.6052).ConclusionsOwing to the limited number of participants, non-inferiority of NMJ-targeted injections could not be determined. However, there was no statistical difference between groups. Larger studies are needed confirm whether the two techniques offer comparable efficacy.Trial registration numberNCT01682148.

Dataset Information

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Publications

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

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