Intrathecal Baclofen Injection Efficacy for Spasticity Management in Patients With Stroke: A Meta-Analysis
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SUBMITTER: Park K
PROVIDER: S-EPMC10990847 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:AimsIntrathecal baclofen (ITB) has proven to be an effective and safe treatment for severe spasticity. However, although ITB is used extensively, clinical decisions are based on very scarce pharmacokinetic-pharmacodynamic (PKPD) data. The aim of this study was to measure baclofen CSF concentrations and clinical effects after administration of various ITB boluses in patients with spasticity and to create a PKPD model for ITB.MethodsTwelve patients with severe spasticity received four different bolus doses of ITB (0, 25, 50, 75 ?g and an optional dose of 100 ?g), administered via a catheter with the tip at thoracic level (Th) 10. After each bolus, 10 CSF samples were taken at fixed time intervals, using a catheter with the tip located at Th12. Clinical effect was assessed by measuring spasticity with the Modified Ashworth Scale (MAS). These data were used to develop a PKPD model.ResultsAll patients achieved an adequate spasmolytic effect with ITB doses varying from 50 to 100 ?g. No serious side effects were observed. CSF baclofen concentrations, as well as the clinical effects, correlated significantly with ITB doses. The PK model predicted a steep spinal concentration gradient of ITB along the spinal axis. The clinical effect could be predicted using a delayed-effect model.ConclusionsITB is an effective and safe therapy with, however, a steep concentration gradient along the spinal axis. This means that the administered baclofen is staying mainly around the catheter tip, which stresses the importance to position the ITB catheter tip closely to the targeted spinal level.
| S-EPMC4693571 | biostudies-literature
Project description:ObjectiveTo assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data.Materials and methodsAn ongoing prospective, long-term, multicenter Product Surveillance Registry (PSR) (NCT01524276) enrolled consented patients implanted with the SynchroMed II infusion system. Pump and catheter performance data were collected, with patients followed prospectively for events related to the device, procedure, and therapy. Investigators provided event descriptions, patient symptoms, and patient outcomes.ResultsWe analyzed registry data from 1743 patients (77% adult, 46.8% female) treated with ITB for severe spasticity at 53 registry sites between August 2003 and October 2017, for an accumulated 6481 patient-years. Discontinuation from the registry was largely (58.6% of discontinued patients) due to study site closure and patient relocation; exit due to an adverse event was limited to 0.3%. After 10 years, 87.2% of adult and 76.3% of pediatric patients continued with ITB. Overall, 99.1% of pumps reaching end of battery life were replaced at the time of explant.ConclusionsITB therapy for the treatment of severe spasticity requires surgical implantation of a programmable infusion system for chronic drug delivery. If complications arise, many necessitate surgical intervention for correction. For spinal and cerebral spasticity in pediatric and adult patients, discontinuation rates due to an adverse event were low (0.3%), and there was high acceptance (99.1%) of surgical intervention for therapy continuation. Patient/caregiver willingness to accept surgical and other risks for therapy continuation was extremely high.
| S-EPMC7687224 | biostudies-literature
Project description:BACKGROUND:Intrathecal baclofen (ITB) is a treatment option for patients with severe poststroke spasticity (PSS) who have not reached their therapy goal with other interventions. METHODS:'Spasticity In Stroke-Randomised Study' (SISTERS) was a randomised, controlled, open-label, multicentre phase IV study to evaluate the efficacy and safety of ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of PSS. Patients with chronic stroke with spasticity in ≥2 extremities and an Ashworth Scale (AS) score ≥3 in at least two affected muscle groups in the lower extremities (LE) were randomised (1:1) to ITB or CMM. Both treatment arms received physiotherapy throughout. The primary outcome was the change in the average AS score in the LE of the affected body side from baseline to month 6. Analyses were performed for all patients as randomised (primary analysis) and all randomised patients as treated (safety analysis). RESULTS:Of 60 patients randomised to ITB (n=31) or CMM (n=29), 48 patients (24 per arm) completed the study. The primary analysis showed a significant effect of ITB therapy over CMM (mean AS score reduction, -0.99 (ITB) vs -0.43 (CMM); Hodges-Lehmann estimate, -0.667(95.1%CI -1.0000 to -0.1667); P=0.0140). More patients reported adverse events while receiving ITB (24/25 patients, 96%; 149 events) compared with CMM (22/35, 63%; 77 events), although events were generally consistent with the known safety profile of ITB therapy. CONCLUSIONS:These data support the use of ITB therapy as an alternative to CMM for treatment of generalised PSS in adults. TRIAL REGISTRATION NUMBER:NCT01032239; Results.
| S-EPMC6031277 | biostudies-literature
Project description:BackgroundOccasionally, patients show dramatic recovery from disorders of consciousness (DOC) under intrathecal baclofen (ITB), an established treatment option for severe supraspinal spasticity. Anecdotal explanations for ITB-related recovery of cognition include modulation of afferent impulses at the spinal level, thereby reducing spasticity-related proprioceptive information overload within cortico-thalamo-cortical connections.ObjectiveIn this retrospective patient chart analysis, we assessed whether a reduction in spasticity would be associated with an increase in Coma Recovery Scale revised (CRS-R) scores in a larger sample of patients than previously published.MethodsFrom a hospital-based ITB treatment register, we extracted data from 26 patients with DOC and severe supraspinal spasticity who improved by >2 points on the Coma Recovery Scale revised (CRS-R) within 6 months after ITB treatment initiation. We assessed Modified Ashworth scale (MAS) scores and CRS-R scores on admission (PRE) and 3 and 6 months after initiation of ITB treatment (3M, 6M). We performed correlation analysis of the scores and their respective changes (PRE to 3M, 3M to 6M). We also correlated the time from acute event until ITB initiation to CRS-R scores at 3M and 6M.ResultsITB led to significant improvement in spasticity based on MAS scores, which did not correlate to the improvements seen in CRS-R total and subscale scores. Daily ITB dose did neither correlate to MAS scores nor to CRS-total scores in the whole patient group, but after 3 months, ITB dose correlated to some CRS-R subscale scores in some patient subgroups. Time until ITB treatment did not correlate to CRS-R scores later on.ConclusionsOur data confirm that ITB may exert beneficial effects in selected DOC patients with respect to improved cognitive functions, which, however, do not correlate to its antispastic effect. The lack of correlation between time to ITB and CRS-R outcome, but significant CRS-R improvements following pump implantation, renders spontaneous remissions unlikely and leaves room for alternative pharmacological mechanisms.
| S-EPMC9120732 | biostudies-literature
Project description:Metachromatic leukodystrophy (MLD) is a rare progressive neurological disorder, often accompanied by motor impairments that are challenging to treat. In this case series, we report the course of treatment with intrathecal baclofen (ITB), aimed at improving daily care and comfort in children and young adults with MLD. All patients with MLD in our centre on ITB treatment for a minimum of 6 months were included (n=10; 4 males, 6 females; mean age 10y 8mo [range 6-24y]). Eight patients had MLD with a predominant spastic movement disorder (sMLD) and two were mainly dyskinetic. Patients with sMLD were compared with matched patients with spastic cerebral palsy (CP). Complication rates related to ITB treatment were similar in both groups. ITB treatment course in the first 6 months after pump implantation appears to show more dose increase in most patients MLD, compared to patients with spastic CP. This may be due to the progressive disease in MLD. ITB is a feasible therapy to improve daily care and comfort in patients with MLD and should therefore be considered early. WHAT THIS PAPER ADDS: Intrathecal baclofen (ITB) is a feasible therapy to improve comfort and daily care in children and young people with metachromatic leukodystrophy (MLD). In the first 6 months of ITB treatment, MLD seems to show more dose increase compared to spastic cerebral palsy.
| S-EPMC7379712 | biostudies-literature
Project description:ObjectiveTo systematically review the effect of intrathecal baclofen pump insertion in children with cerebral palsy (CP) with respect to scoliosis.MethodsA systematic literature search was conducted in PubMed, Embase, Cochrane Library, and Google Scholar databases up to June 2022. The inclusion criteria were as follows: (1) studies with a quantitative study design; (2) studies with a study group of children with CP; (3) studies comparing scoliosis in children with and without an intrathecal baclofen pump; and (4) studies with Cobb's angle as a parameter.ResultsOf the 183 studies found, four studies, all of which were retrospective comparative studies, met the aforementioned inclusion criteria. All studies were homogeneous (I2=0%, p=0.53) and intrathecal baclofen pump insertion accelerated the progression of scoliosis (standard mean difference=0.27; 95% confidence interval=0.07-0.48).ConclusionIntrathecal baclofen pumps have been used to alleviate spasticity in children with CP, thus aiding their daily activities and movements. However, their advantages and disadvantages should be reviewed after sufficient time considering the pumps' negative effect on the course of scoliosis.
| S-EPMC10020052 | biostudies-literature
Project description:Elucidating patients´ experiences of living with chronic progressive hereditary ataxia and the symptomatic treatment with intrathecal baclofen (ITB) is the objective of the current study. A multicenter qualitative study with four patients included due to the rare combination of hereditary ataxia and ITB therapy was designed to elucidate participants' experiences through semi-structured interviews. The transcribed text was analyzed according to content analysis guidelines. Overall we identified living in the present/ taking one day at a time as the main theme covering the following categories: 1) Uncertainty about the future as a consequence of living with a hereditary disease; The disease; 2) Impact on life as a whole, 3) Influence on personal life in terms of feeling forced to terminate employment, 4) Limiting daily activities, and 5) ITB therapy, advantages, and disadvantages. Uncertainty about the future was the category that affected participants' personal life, employment, and daily activities. The participants' experience of receiving ITB therapy was expressed in terms of improved quality of life due to better body position and movement as well as better sleep and pain relief.
| S-EPMC5487051 | biostudies-literature
Project description:BackgroundReal-world data regarding the impact of onabotulinumtoxinA on healthcare resource utilization and costs for post-stroke spasticity are scarce.ObjectiveTo compare differences in 12-month healthcare resource utilization and costs before and after post-stroke spasticity management including onabotulinumtoxinA.MethodsThis retrospective claims analysis of IBM MarketScan Commercial and Medicare Supplemental databases included adults with ≥ 1 onabotulinumtoxinA claim for post-stroke spasticity (1 January 2010 to 30 June 2018) and continuous enrolment for ≥ 12 months pre- and post-index (first onabotulinumtoxinA claim date). All-cause and spasticity-related healthcare resource utilization and costs were compared 12 months pre- and post-index (McNemar's χ2 test or paired t-test). A subgroup analysis assessed effect of stroke-to-index interval on costs.ResultsAmong 735 patients, mean (standard deviation) stroke-date-to-index-date interval was 284.5 (198.8) days. Decreases were observed post-index for mean all-cause outpatient (62.9 vs 60.5; p ≤ 0.05) and emergency department visits (1.1 vs 0.8; p ≤ 0.0001), and hospital admissions (1.5 vs 0.4; p ≤ 0.0001). Increase in prescription fills (43.0 vs 53.7) was seen post-index. Post-index decreases in all-cause (-66%) and spasticity-related (-51%) costs were driven by reduced inpatient care costs. Findings were consistent regardless of stroke-date-to-index-date interval.ConclusionSignificant reductions in healthcare resource utilization and costs were observed after 1 year of post-stroke spasticity management including onabotulinumtoxinA. Long-term studies are needed to establish causality.
| S-EPMC10715292 | biostudies-literature
Project description:BackgroundOne of the main objectives of stroke rehabilitation is to alleviate post-stroke spasticity. Over the recent years, many studies have explored the potential benefits of whole-body vibration (WBV) treatment for post-stroke spasticity, but it is still controversial.ObjectiveThe current study aims to assess the efficacy and safety of WBV for post-stroke spasticity and determine the appropriate application situation.MethodsFrom their establishment until August 2022, the following databases were searched: PubMed, Web of Science, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Medline, China National Knowledge Infrastructure (CNKI), and Wanfang. Only randomized controlled trials (RCTs) that were published in either English or Chinese were taken into consideration. We independently filtered the research, gathered the data from the studies, and evaluated the research quality (Cochrane RoB tool) and the overall evidence quality (GRADE). Rev Man 5.4 software was utilized to conduct statistical analysis.ResultsIn this analysis, 11 RCTs with 475 patients that reported on the effectiveness of WBV therapy for post-stroke spasticity were taken into account. Compared to the control groups, the results revealed that WBV combined with conventional rehabilitation at a vibration frequency lower than 20 Hz (SMD = -0.58, 95% CI: -0.98 to -0.19, P = 0.004) was more effective in relieving upper (SMD = -0.53, 95% CI: -1.04 to 0.03, P = 0.03) and lower limb spasticity (SMD = -0.21, 95% CI: -0.40 to -0.01, P = 0.04); similarly, it was superior for patients aged under 60 years (SMD = -0.41, 95% CI: -0.66 to -0.17, P = 0.0008) with acute and subacute stroke (SMD = -0.39, 95% CI: -0.68 to -0.09, P = 0.01). The valid vibration for reducing spasticity was found to last for 10 min (SMD = -0.41, 95% CI: -0.75 to -0.07, P = 0.02). None of the included studies revealed any serious adverse impact.ConclusionModerate-quality evidence demonstrated when WBV was used as an adjuvant, vibration <20 Hz for 10 min was effective and secure in treating upper and lower limb spasticity in patients with acute and subacute stroke under the age of 60 years.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022293951.
| S-EPMC9909105 | biostudies-literature
Project description:PurposeTo study the efficacy of traditional Thai massage (TTM) versus conventional physical therapy (PT) programs in treating muscle spasticity, functional ability, anxiety, depression, and quality of life (QoL) in Thai stroke patients.MethodsThis randomized controlled trial with a blinded assessor was carried out at the Department of Rehabilitation Medicine, Siriraj Hospital (Bangkok, Thailand). The study included 50 stroke (onset ≥ 3 months) outpatients experiencing spasticity at the elbow or knee muscles at a grade of ≥ 1+ on the modified Ashworth Scale who were ≥ 50 years old and able to communicate. The subjects were randomly allocated to the treatment group receiving TTM (24 subjects) or the control group receiving the PT program (26 subjects). Both groups received treatment (either TTM or PT) twice a week for 6 weeks. Spasticity grade, functional ability, anxiety, depression, and QoL were measured at Week 0 and Week 6.ResultsAt Week 6, the percentage of patients whose modified Ashworth Scale score had decreased by at least one grade was not statistically significant between the two groups. Both TTM and PT groups experienced a significant increase in functional ability and QoL, but no difference was found between the groups. Anxiety and depression scores showed a decreasing trend in the TTM group.ConclusionThis preliminary report showed no evidence that TTM differed from the PT program in decreasing spasticity. However, both interventions may relieve spasticity, increase functional ability, and improve QoL after 6 weeks. Only TTM can decrease anxiety and depression scores. Further studies with adequate sample size are necessary.
| S-EPMC4136956 | biostudies-literature