Observational studyPM & R : the journal of injury, function, and rehabilitation2021
Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity.
Observational study in PM & R : the journal of injury, function, and rehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01930786 (ASPIRE), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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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.
ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- OnabotulinumtoxinA in the Management of Pain in Adult Patients with Spasticity: A Systematic Literature Review.Toxins · 2025Pooled it
- Relief of pain associated with spasticity in adult patients after treatment with onabotulinumtoxinA: Post hoc observational results from the ASPIRE study.PM & R : the journal of injury, function, and rehabilitation · 2026Observational
- Changes in tibialis anterior muscle activity following tibial nerve block in adults with spastic equinovarus foot: an observational pilot study.Journal of rehabilitation medicine · 2025Observational
- Is the Silfverskiöld Test a valid tool for evaluating calf muscles spastic overactivity in patients with stroke? A retrospective observational study.European journal of physical and rehabilitation medicine · 2024Observational
- The Role of Botulinum Toxin Type-A in Spasticity: Research Trends from a Bibliometric Analysis.Toxins · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals.
objectiveTo explore real-world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study.
designTwo-year, multicenter, prospective, observational registry (NCT01930786).
settingFifty-four international clinical sites. PATIENTS: Adults (naïve or non-naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome.
interventionsOnabotulinumtoxinA administered at the clinician's discretion.
main outcome measuresOnabotulinumtoxinA treatment utilization, clinician- and patient-reported satisfaction.
resultsIn ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty-one adverse events (AEs) in 18 patients (3.4%) were considered treatment-related. Sixty-seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment-related. No new safety signals were identified.
conclusionsASPIRE provides long-term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real-world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.
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