Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

Phase 2/3 Recruiting 90 enrolled University of Antwerp Fonds de la Recherche en Santé du Québec · collab Instituto de Investigación Sanitaria Aragón · collab Instituto de Salud Carlos III · collab McGill University · collab Research Foundation Flanders · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

Timeline

Start: 2024-09-01
Primary completion: 2026-12-30
Completion: 2027-03-29

Publications

Pujol-Fuentes C, Eeckhaut B, Fernandez Carnero S, Fernandez Sanchis D, Wein T, Herrero P, Saeys W, Levin MF. Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC). PLoS One. 2026 May 20;21(5):e0334571. doi: 10.1371/journal.pone.0334571. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Botulinum toxin type A	Protein / enzyme biologic	300 iu	—
Comparator	Botulinum toxin type A	Protein / enzyme biologic	400 iu	—

Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

Summary

Timeline

Publications

Drugs

Indications