Clinical trial NCT06296082: Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Stroke
Keywords: Stroke [Mesh]
Dry Needling
Muscle Spasticity [Mesh]
Botulinum Toxins [Mesh]
Tonic Stretch Reflex Threshold
Ultrasound imaging
Gait analysis
Quality of Life [Mesh]
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Sanitaria Aragón
name: McGill University
name: Instituto de Salud Carlos III
name: Fonds de la Recherche en Santé du Québec
name: Research Foundation Flanders
First posted: 2024-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized, controlled, multiple-baseline, and assessor blinded multicenter equivalence trial with two parallel groups.
Primary purpose: TREATMENT

Brief 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

Eligibility 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.

Primary outcomes:
measure: Tonic Stretch Reflex Threshold (TSRT)
timeFrame: Week 1 to 15 and 19.
Secondary outcomes:
measure: Muscle thickness
timeFrame: Week 1 to 15 and 19.
measure: Pennation angle
timeFrame: Week 1 to 15 and 19.
measure: Concurrence matrices
timeFrame: Week 1 to 15 and 19.
measure: Resistance to passive stretching
timeFrame: Week 1 to 15 and 19.
measure: Gait analysis
timeFrame: Week 1,2,9,15 and 19
measure: Functional mobility
timeFrame: Week 1,2,9,15 and 19
measure: Functional mobility
timeFrame: Week 1,2,9,15 and 19
measure: Muscle Strength
timeFrame: Week 1 to 15 and 19.
measure: Quality of life analysis
timeFrame: Week 1, 15 and 19.
measure: Cost-effectiveness
timeFrame: Week 19.
measure: Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events
timeFrame: Week 3 to 14 and 19.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universiteit Antwerpen
state: Flandes
city: Montréal
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Universidad de Zaragoza
name: Pablo Herrero Gallego, PhD
role: PRINCIPAL_INVESTIGATOR
References: