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Study comparing Dry Needling and Botulinum Toxin Type A treatments for leg muscle stiffness in stroke patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the treatment of spasticity in the lower limbs that occurs after a stroke. Spasticity is a condition where muscles become stiff and difficult to move. The study compares two different treatments: Botulinum Toxin type A (also known as Botox) injections and Dry Needling. Botox is given as an intramuscular injection, with doses up to 400 units.

The main purpose of this research is to understand how these two treatments affect spasticity at the spinal cord level. The study will monitor changes in muscle stiffness, walking ability, and quality of life over several weeks. Participants will receive either Botox injections or dry needling treatment, and their progress will be tracked through various measurements and tests.

The study will last approximately 19 weeks, during which participants will undergo regular assessments of their muscle condition, walking ability, and overall function. The research team will use various tools to measure improvements, including walking tests and ultrasound imaging of the muscles. They will also evaluate which treatment provides better value for the cost.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your first visit includes evaluation of spasticity (muscle stiffness) in your ankle using special measurements

    You will undergo walking tests and mobility assessment

    An ultrasound examination of your leg muscles will be performed

    You will complete a quality of life questionnaire

  2. Step 2

    Weekly monitoring - weeks 1 and 2

    Your ankle muscle stiffness will be measured weekly

    Ultrasound imaging of your leg muscles will be performed each week

  3. Step 3

    Treatment start - week 3

    You will receive either Botulinum toxin injection or dry needling treatment in your ankle muscles

    Measurements will be taken before and after the treatment

    The treatment involves an injection into the muscle

  4. Step 4

    Weekly follow-up - weeks 4 to 15

    Weekly visits for ankle muscle stiffness measurements

    Regular ultrasound imaging of leg muscles

    Walking and mobility tests at weeks 9 and 15

    Quality of life assessment at week 15

  5. Step 5

    Final assessment - week 19

    Final measurement of ankle muscle stiffness

    Last walking and mobility assessment

    Final ultrasound examination

    Completion of quality of life questionnaire

Who can join the trial?

8 criteria

  • Age between 18 and 85 years old
  • Must have spasticity (increased muscle stiffness and tension) in the lower leg muscles that bend the ankle downward after experiencing a stroke
  • Must be experiencing their first stroke
  • The stroke must have occurred within the last 12 months
  • Must not have previously received Dry Needling (insertion of thin needles into muscle tissue) or Botulinum Toxin type A (medication injected into muscles) treatments for spasticity
  • Must have at least 20 degrees of ankle movement when the knee is bent at approximately 30 degrees
  • Must be able to walk independently, with or without walking aids (such as a cane or walker)
  • Both men and women may participate

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • History of allergic reactions to botulinum toxin (a medication used to reduce muscle stiffness)
  • Presence of active infections in the treatment areas
  • Severe heart conditions or unstable cardiovascular disease
  • Pregnancy or breastfeeding
  • Use of blood-thinning medications (anticoagulants)
  • Presence of metal implants in the treatment area
  • Previous stroke within the last 3 months
  • Severe cognitive impairment that prevents following instructions
  • Uncontrolled epilepsy (seizure disorder)
  • Active skin conditions in the treatment area
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • History of neuromuscular junction disorders (conditions affecting nerve and muscle connections)
  • Severe muscle weakness in the affected limb
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Verified sites

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  • Emmaues

    Verified

    BelgiumMechelen, Belgium

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Investigated drugs

  • Botulinum Toxin Type A

    is a medication that helps reduce muscle stiffness and spasms. It works by blocking signals from nerves to muscles, which helps relax overly tight muscles. In stroke patients, it's commonly used to treat spasticity (muscle tightness) in the legs.

  • Dry Needling

    is a physical therapy technique where thin needles are inserted into specific points in muscles. While not a medication, this therapy aims to release tension in tight muscles and reduce pain. The needles help stimulate and relax the muscles, potentially improving movement in stroke patients with leg spasticity.

What is already known about the treatment

Botulinum Toxin Type A - A highly purified protein neurotoxin that is administered through intramuscular injection to treat muscle spasticity, particularly in post-stroke patients. This medication works by blocking the release of acetylcholine at nerve endings, which temporarily reduces muscle contractions and relieves spasticity in affected limbs. Currently widely used in clinical practice and extensively documented in medical literature, Botulinum Toxin Type A belongs to the class of neuromuscular blocking agents and has proven particularly effective in managing lower limb spasticity in stroke survivors, with effects typically lasting several months after treatment. Note: No other medications were mentioned in the provided trial data that would require description.

Investigated diseases

Post-stroke Spasticity - A muscle control disorder that develops after a stroke, characterized by tight or stiff muscles and exaggerated muscle tone. The condition occurs when damage to certain parts of the brain or spinal cord affects the signals between the nervous system and muscles. It typically develops in the first few weeks or months following a stroke, causing involuntary muscle contractions and resistance to stretch in affected limbs. The muscles remain in a constant state of contraction, leading to stiffness and reduced range of motion. This condition commonly affects the arms, legs, and facial muscles, potentially interfering with normal movement patterns and daily activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510866-18-00Protocol code49317Estimated enrolment60 patientsSponsorUniversity Of Antwerp

sourced from the EU Clinical Trials Register and site verification

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