Trial reportJournal of neurology, neurosurgery, and psychiatry2018
Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).
Trial report in Journal of neurology, neurosurgery, and psychiatry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment
Spinal Cord Stimulation for Poststroke Spasticity: a Multicentre, Double-blind, Randomised, Sham-controlled Trial (SCS-PSS)
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Comparative pharmacotherapeutic efficacy and dose-related safety profiles of intrathecal baclofen: a systematic review and meta-analysis in neurological spasticity.Frontiers in pharmacology · 2026Pooled it
- Intrathecal baclofen efficacy for managing motor function and spasticity severity in patients with cerebral palsy: a systematic review and meta-analysis.BMC neurology · 2024Pooled it
- Spinal cord stimulation for upper limb motor function in people with chronic post-stroke hemiparesis: a feasibility trial.Nature medicine · 2026Trial
- Trial
- Radial Extracorporeal Shock Wave Therapy for Lower-Limb Spasticity in an Individual With Subacute Stroke: A Case Report.Clinical case reports · 2026Article
- 2024 Japan Society for Stereotactic and Functional Neurosurgery Guidelines for Stereotactic and Functional Neurosurgery.Neurologia medico-chirurgica · 2026Article
- Current techniques for the treatment of spasticity and their effectiveness.EFORT open reviews · 2025Article
- Efficacy, Indications, and Safety of Intrathecal Baclofen Pump: A Narrative Review.Current pain and headache reports · 2025Review
- Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Intrathecal drug delivery for the management of pain and spasticity in adults: British Pain Society's recommendations for best clinical practice.British journal of pain · 2024Article
- Evaluating Community-Based Intrathecal Baclofen Therapy: Effectiveness, Safety, and Feasibility.Journal of clinical medicine · 2024Article
- Intrathecal Baclofen Injection Efficacy for Spasticity Management in Patients With Stroke: A Meta-Analysis.Brain & NeuroRehabilitation · 2024Article
- Best Practice Guidelines for the Management of Patients with Post-Stroke Spasticity: A Modified Scoping Review.Toxins · 2024Article
- Characteristics of Changes in Intrathecal Baclofen Dosage over Time due to Causative Disease.Neurologia medico-chirurgica · 2023Article
- Post-Stroke Spastic Movement Disorder and Botulinum Toxin A Therapy: Early Detection And Early Injection.Annals of rehabilitation medicine · 2023Article
- Article
- The Options for Neuraxial Drug Administration.CNS drugs · 2022Review
- European expert consensus on improving patient selection for the management of disabling spasticity with intrathecal baclofen and/or botulinum toxin type A.Journal of rehabilitation medicine · 2022Article
- Sustained Baclofen-Induced Activation of GABAFrontiers in molecular neuroscience · 2021Article
- Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.Neuromodulation : journal of the International Neuromodulation Society · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntrathecal 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).
resultsOf 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.
conclusionsThese data support the use of ITB therapy as an alternative to CMM for treatment of generalised PSS in adults. TRIAL REGISTRATION NUMBER: NCT01032239; Results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.