Efficacy of botulinum toxin A combined with extracorporeal shockwave therapy in post-stroke spasticity: a systematic review
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SUBMITTER: Du Y
PROVIDER: S-EPMC10979702 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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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.
| S-EPMC8649216 | biostudies-literature
Project description:Stroke-induced spasticity is a prevalent condition affecting stroke survivors, significantly impacting their quality of life. Botulinum Toxin A injections are widely used for its management, yet the long-term effects and optimal management strategies remain uncertain. This retrospective study analyzed medical records of 95 chronic stroke patients undergoing long-term BoNT-A treatment for spasticity. Demographic data, treatment duration, dosage variability, and dropout rates were assessed over a period ranging from 2 to 14 years. The study revealed a notable extension of the interval between BoNT-A injections throughout the treatment duration. Dropout rates peaked during the initial 5 years of treatment, perhaps due to perceived treatment ineffectiveness. Additionally, a trend of escalating dosage was observed across all groups, indicating a potential rise in the severity of spasticity or changes in treatment response over time. BoNT-A injections emerged as the predominant treatment choice for managing post-stroke spasticity. The delayed initiation of BoNT-A treatment underscores the need for heightened awareness among healthcare providers to recognize and manage spasticity promptly post-stroke. Patients' expectations and treatment goals should be clearly defined to optimize treatment adherence, while the observed escalation in dosage and treatment intervals emphasizes the dynamic nature of spasticity and underscores the importance of monitoring long-term treatment outcomes.
| S-EPMC11436082 | biostudies-literature
Project description:Early management of spasticity may improve stroke outcome. Botulinum toxin type A (BoNT-A) is recommended treatment for post-stroke spasticity (PSS). However, it is usually administered in the chronic phase of stroke. Our aim was to determine whether the length of time between stroke onset and initial BoNT-A injection has an effect on outcomes after PSS treatment. This multicenter, longitudinal, cohort study included stroke patients (time since onset <12 months) with PSS who received BoNT-A for the first time according to routine practice. The main outcome was the modified Ashworth scale (MAS). Patients were evaluated before BoNT-A injection and then at 4, 12, and 24 weeks of follow-up. Eighty-three patients with PSS were enrolled. MAS showed a significant decrease in PSS at 4 and 12 weeks but not at 24 weeks after treatment. Among the patients with a time between stroke onset and BoNT-A injection >90 days, the MAS were higher at 4 and 12 weeks than at 24 weeks compared to those injected ≤90 days since stroke. Our findings suggest that BoNT-A treatment for PSS should be initiated within 3 months after stroke onset in order to obtain a greater reduction in muscle tone at 1 and 3 months afterwards.
| S-EPMC8225105 | biostudies-literature
Project description:Post-stroke spasticity impedes patients' rehabilitation progress. Contradictory evidence has been reported in using Botulinum Neurotoxin type A (BoNT-A) to manage post-stroke lower extremity spasticity (PLES); furthermore, an optimum dose of BoNT-A for PLES has not yet been established. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to identify the efficacy and optimal dose of BoNT-A on PLES. "Meta" and "Metafor" packages in R were used to analyze the data. Hedges' g statistic and random effect model were used to calculate and pool effect sizes. Twelve RCTs met the eligibility criteria. Muscle tone significantly improved in week four, week eight, and maintained to week twelve after BoNT-A injection. Improvements in functional outcomes were found, some inconsistencies among included studies were noticed. Dosage analysis from eight studies using Botox® and three studies using Dysport® indicated that the optimum dose for the commonest pattern of PLES (spastic plantar flexors) is medium-dose (approximately 300U Botox® or 1000 U Dysport®). BoNT-A should be regarded as part of a rehabilitation program for PLES. Furthermore, an optimal rehabilitation program combined with BoNT-A management needs to be established. Further studies should also focus on functional improvement by BoNT-A management in the early stage of stroke.
| S-EPMC8234518 | biostudies-literature
Project description:ObjectiveTo evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.MethodsThis prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.ResultsThere was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.ConclusionNABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.
| S-EPMC9452292 | biostudies-literature
Project description:BackgroundPatients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications.Methods/designThis protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain.Trial registrationsISRCTN57435427, EudraCT2010-021257-39, NCT01882556.
| S-EPMC3895790 | biostudies-literature
Project description:IntroductionSpasticity is a common complication of stroke, which is related to poor motor recovery and limitations in the performance of activities. Both transcranial magnetic stimulation (TMS) and extracorporeal shockwave therapy (ESWT) are effective treatment methods for poststroke spasticity (PSS). However, there is no existing study exploring the safety and effectiveness of TMS combined with ESWT for PSS.Methods and analysisThis study will be a prospective, single-centre, randomised, factorial, controlled clinical trial. In this trial, 136 patients with PSS will be randomly divided into 4 groups: experimental group 1 (TMS), experimental group 2 (ESWT), experimental group 3 (ESWT+TMS) and control group, 34 patients in each group; all patients received routine rehabilitation. Outcome measures will be assessed by 4 time points: baseline (T0), 2 weeks after initiation of treatment (T1), 4 weeks after initiation of treatment (T2) and follow-up (4 weeks after the end of treatment, T3). The primary outcome is the modified Ashworth scale at T2. The secondary outcomes include the modified Tardieu scale for the degree of spasticity, the Fugl-Meyer assessment scale and range of motion (ROM) for motor function, the stroke-specific quality of life scale (SS-QOL) and modified Barthel index for activities of life, cortical excitability measured by TMS-surface electromyography (EMG), cerebral cortex oxygen concentrations measured by functional near-infrared spectroscopy (fNIRS) and Hmax/Mmax ratio measured by EMG.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Army Medical Center of PLA (Approval No. 2024-04) on 24 January 2024. The study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberThis study was registered in the Chinese Clinical Trial Registry (https://www.chictr.org.cn/; unique identifier: ChiCTR2400080862; data: 9 February 2024; study protocol V. 2.0).
| S-EPMC11749531 | biostudies-literature
Project description:ObjectiveDoes early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function.DesignRandomised placebo-controlled-trial.SettingSpecialised stroke-unit.Participants & interventionPatients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment).Outcome-measuresSpasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection.ResultsNinety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively.ConclusionBoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function.Trial registrationEudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.
| S-EPMC7944432 | biostudies-literature
Project description:ObjectiveTo test the feasibility and efficacy of the VibroTactile Stimulation (VTS) Glove, a wearable device that provides VTS to the impaired limb to reduce spastic hypertonia.DesignProspective 2-arm intervention study-including 1 group of patients who use Botulinum toxin (BTX-A) for spasticity and 1 group of patients who do not use BTX-A.SettingParticipants were recruited through rehabilitation and neurology clinics.ParticipantsPatients with chronic stroke (N=20; mean age=54 years, mean time since stroke=6.9 years). Patients who were previously receiving the standard of care (BTX-A injection) were eligible to participate and started the intervention 12 weeks after their last injection.InterventionParticipants were instructed to use the VTS Glove for 3 hours daily, at home or during everyday activities, for 8 weeks.Main outcome measuresSpasticity was assessed with the Modified Ashworth Scale and the Modified Tardieu Scale at baseline and then at 2-week intervals for 12 weeks. Primary outcomes were the difference from baseline and at week 8 (end of VTS Glove use) and week 12 (4 weeks after stopping VTS Glove use). Patients who were receiving BTX-A were also assessed during the 12 weeks preceding the start of VTS Glove use to monitor the effect of BTX-A on spastic hypertonia. Range of motion and participant feedback were also studied.ResultsA clinically meaningful difference in spastic hypertonia was found during and after daily VTS Glove use. Modified Ashworth and Modified Tardieu scores were reduced by an average of 0.9 (P=.0014) and 0.7 (P=.0003), respectively, at week 8 of daily VTS Glove use, and by 1.1 (P=.00025) and 0.9 (P=.0001), respectively, 1 month after stopping VTS Glove use. For participants who used BTX-A, 6 out of 11 showed greater change in Modified Ashworth ratings during VTS Glove use (mean=-1.8 vs mean=-1.6 with BTX-A) and 8 out of 11 showed their lowest level of symptoms during VTS Glove use (vs BTX-A).ConclusionsDaily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of the participants who had regularly used BTX-A, the VTS Glove provided equal or greater symptom relief.
| S-EPMC11326884 | biostudies-literature
Project description:BackgroundInconsistent data have been reported for the effectiveness of intramuscular botulinum toxin type A (BTXA) in patients with limb spasticity after stroke. This meta-analysis of available randomized controlled trials (RCTs) aimed to determine the efficacy and safety of BTXA in adult patients with upper and lower limb spasticity after stroke.MethodsAn electronic search was performed to select eligible RCTs in PubMed, Embase, and the Cochrane library through December 2018. Summary standard mean differences (SMDs) and relative risk (RR) values with corresponding 95% confidence intervals (CIs) were employed to assess effectiveness and safety outcomes, respectively.ResultsTwenty-seven RCTs involving a total of 2,793 patients met the inclusion criteria, including 16 and 9 trials assessing upper and lower limb spasticity cases, respectively. For upper limb spasticity, BTXA therapy significantly improved the levels of muscle tone (SMD=-0.76; 95% CI -0.97 to -0.55; P<0.001), physician global assessment (SMD=0.51; 95% CI 0.35-0.67; P<0.001), and disability assessment scale (SMD=-0.30; 95% CI -0.40 to -0.20; P<0.001), with no significant effects on active upper limb function (SMD=0.49; 95% CI -0.08 to 1.07; P=0.093) and adverse events (RR=1.18; 95% CI 0.72-1.93; P=0.509). For lower limb spasticity, BTXA therapy was associated with higher Fugl-Meyer score (SMD=5.09; 95%CI 2.16-8.01; P=0.001), but had no significant effects on muscle tone (SMD=-0.12; 95% CI -0.83 to 0.59; P=0.736), gait speed (SMD=0.06; 95% CI -0.02 to 0.15; P=0.116), and adverse events (RR=1.01; 95% CI 0.71-1.45; P=0.949).ConclusionsBTXA improves muscle tone, physician global assessment, and disability assessment scale in upper limb spasticity and increases the Fugl-Meyer score in lower limb spasticity.
| S-EPMC6475544 | biostudies-literature