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NCT Number: NCT06296082

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universiteit Antwerpen, Antwerp, Flanders, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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.

dry needling

Other

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.

Primary outcomes

  1. Tonic Stretch Reflex Threshold (TSRT)

    Time frame: Week 1 to 15 and 19.

    TSRT is a novel measures of stretch reflex excitability that provide an indirect indicator of the excitability of α-motoneurons at the level of the spinal cord.

Secondary outcomes

  1. Muscle thickness

    Time frame: Week 1 to 15 and 19.

    It is the estimation of the thickness of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle between the deep and superficial aponeuroses.

  2. Pennation angle

    Time frame: Week 1 to 15 and 19.

    It is the angle between the deep fascia and the line of the fascicle length.

  3. Concurrence matrices

    Time frame: Week 1 to 15 and 19.

    Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images.

  4. Resistance to passive stretching

    Time frame: Week 1 to 15 and 19.

    It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity (no resistance to passive stretching) and 4 representing the most severe spasticity (resistance to passive stretching), characterized by complete rigidity.

  5. Gait analysis

    Time frame: Week 1,2,9,15 and 19

    It will be done with motion capture systems using wearable and inertial sensors. Canada and Belgium: Xsens system (MVN Awinda, Movella, Hendersen, USA); Spain: Move Human Sensors MoCap System.

  6. Functional mobility

    Time frame: Week 1,2,9,15 and 19

    Measured by Time Up and Go (TUG).

  7. Functional mobility

    Time frame: Week 1,2,9,15 and 19

    Measured by 10 Meter Walk Test (10MWT)

  8. Muscle Strength

    Time frame: Week 1 to 15 and 19.

    Muscle strength will be measured by hand-held dynamometry (MicroFET 2)

  9. Quality of life analysis

    Time frame: Week 1, 15 and 19.

    It will be assessed with the EuroQOL-5D (Euro Quality of Life-5 Dimensions-5 Levels). Responses from the questionnaire will be converted to health-state utility values, where higher values represent improved quality of life. Index scores range from -0.59 to 1, where 1 is the best possible health state.

  10. Cost-effectiveness

    Time frame: Week 19.

    Costs related to treatment will be assessed by computing the ICER (Incremental cost-effectiveness ratio) in €/QALY (Quality-Adjusted Life Year)

  11. Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events

    Time frame: Week 3 to 14 and 19.

    Description of the adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Pujol Fuentes, Msc

CONTACT

[email protected]

+34661075990

Pablo Herrero Gallego, PhD

CONTACT

[email protected]

+34646168248

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec
  • Instituto de Investigación Sanitaria Aragón
  • Instituto de Salud Carlos III
  • McGill University
  • Research Foundation Flanders

Registry information

Official study 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

Acronym: STROKEPOC

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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