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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Eztchiy Mechelen Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.05.2024
Spain Spain
Recruiting
01.05.2024

Trial locations

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.

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 ID:
2024-510866-18-00
Protocol code:
49317
NCT ID:
NCT06296082
Trial Phase:
Therapeutic exploratory (Phase II)

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