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A Spanish organization is preparing a project proposal for the call “Fostering Pragmatic Comparative-Effectiveness Trials in Non-communicable Diseases (EffecTrial),” ERA4Health program.
This project aims to provide robust evidence on the comparative effectiveness and cost-effectiveness of botulinum toxin injections and dry needling for managing post-stroke spasticity. Specifically, they want to determine whether dry needling can serve as a viable alternative or complement to the current standard treatment.
To achieve this, a multicenter pragmatic clinical trial will be conducted in three countries, each conducting its own trial as part of the global study. The protocol will be common, and the two treatment arms will be dry needling and the standard treatment of botulinum toxin injections. The study will integrate real-world data from these countries to explore differences in clinical outcomes, patient-reported experiences, and healthcare resource utilization.
Additionally, they aim to identify factors influencing treatment success, evaluate the role of ultrasound imaging in optimizing interventions, and generate actionable insights to guide clinical decision-making and policy development. Ultimately, the findings are expected to advance the standard of care for post-stroke spasticity, improve patient outcomes, and support more efficient allocation of healthcare resources globally.
To complete the consortium, which also includes a Polish university, they are looking for clinical research centres or hospitals from Austria, Czech Republic, France, Germany, Ireland, Israel, Italy, Latvia, Lithuania, Norway or Slovakia. These partners should be able to contribute with their expertise in key areas such as:
• Cost-effectiveness analysis
• Ultrasound imaging analysis
• Other complementary fields that align with the funding call priorities and add significant value to the consortium such as gender approach, patient and public involvement, amongst other that could provide additional value to the research/consortium.
Each partner institution will receive dry needling training to develop and implement this treatment in their respective country. This will ensure consistency and quality across the trial sites while fostering capacity-building within each participating country.
This trial provides a unique opportunity to advance the post-stroke spasticity management evidence base, addressing clinical effectiveness and healthcare resource optimization.
Official deadline of the call: 28th January 2025
Deadline for expressions of interest: 15th January 2025
Anticipation duration of the project: 4 years
Codice di riferimento della ricerca partner: RDRES20241217003
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