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

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.

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

Inclusion Criteria:

1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion ~30°.
7. independent ambulation with or without aids.

Exclusion Criteria:

1. medical conditions interfering with data interpretation.
2. contraindications for BTX-A or DN treatment.
3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
4. pregnant or breastfeeding.