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NCT Number: NCT03131791

Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity

Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

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Key information

Conditions

Post-stroke Upper Limb Spasticity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

About this study

Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18-80 year-old
  • The onset of stroke must be at least 6 months previously
  • Spasticity measured as Modified Asthow Scale more(MAS) than 1+
  • Signed informed consent form

Exclusion criteria

  • Patients with marked contractures in the elbow and wrist (MAS>4)
  • Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
  • Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study

Treatment and study plan

Shock wave

Device

42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.

Botulinum toxin A

Drug

42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.

Primary outcomes

  1. The change of spasticity of elbow

    Time frame: Between baseline and 4 weeks post-treatment

    Modified Ashworth Scale (MAS) for spasticity

Secondary outcomes

  1. The change of Tardieu scale scores for the elbow and wrist

    Time frame: Between baseline and 1, 4,8 weeks post-treatment

    Tardieu scale scores for spasticity

  2. The change of upper limb function

    Time frame: Between baseline and 1,4,8 weeks post-treatment

    The Fugl-Meyer Assessment (FMA) for upper limb function

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Aug 20, 2018

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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