NCT06296082

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

Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary hypothesis is that the effects of DN on post-stroke spasticity in the lower limbs at the spinal level is comparable to BTX-A in reducing spasticity by decreasing stretch reflex excitability. Sample size: Spain, Canada and Belgium will recruit 90 participants (30 per country) The platform used for randomization and electronic data collection will be Research Electronic Data Capture (REDcap): https://www.project-redcap.org/. A shared license will be used among the countries involved in the study. Data dictionary: * DN: Dry Needling * BTX-A: Botulinum toxin type A * TSRT: Tonic Stretch Reflex Threshold * MAS: Modified Ashworth Scale * 10MWT: 10 Metre Walk Test * TUG: Timed Up \& Go * PPI: Public and Patient Involvement * SOP: Standard Operating Procedure

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.
OTHER	Dry Needling	Dry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2024-03-06
• Last updated: 2025-02-20

Locations

3 sites across 3 countries: Belgium, Canada, Spain

Regulatory

• FDA-regulated drug study