Comparing Dry Needling and Botulinum Toxin for 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 study is testing whether dry needling can help reduce muscle tightness in the legs of stroke survivors just as well as a common injection treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 3 sites (Antwerp, Flanders and 2 other locations) |
| Trial ID | NCT06296082 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized parallel group study conducted in Spain, Canada, and Belgium, aimed at comparing the effectiveness of Botulinum Toxin type A (BTX-A) and Dry Needling (DN) in treating lower limb spasticity in patients who have experienced a first stroke within the last 12 months. Participants will be randomly assigned to receive either one session of BTX-A or 12 weekly sessions of DN. The study will assess the effects of these treatments on spasticity using blinded evaluators before, during, and after treatment, with a follow-up at four weeks. The primary hypothesis is that DN will have comparable effects to BTX-A in reducing spasticity by decreasing stretch reflex excitability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced their first stroke within the last 12 months and exhibit ankle plantar flexor spasticity.
Not a fit: Patients with medical conditions that interfere with data interpretation or those who have contraindications for BTX-A or DN treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for post-stroke spasticity, improving mobility and quality of life for patients.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of DN and BTX-A is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Antwerp, Flanders and 2 other locations
- Universiteit Antwerpen — Antwerp, Flanders, Belgium (Recruiting)
- Jewish Rehabilitation Hospital — Montreal, Quebec, Canada (Recruiting)
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: Pablo Herrero Gallego, PhD — Universidad de Zaragoza
- Study coordinator: Pablo Herrero Gallego, PhD
- Email: pherrero@unizar.es
- Phone: +34646168248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.