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

Post-Stroke Upper Limb Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131791
• Other study ID #: 16MMHIS066e
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: August 2018
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged between 18-80 year-old

2. The onset of stroke must be at least 6 months previously

3. Spasticity measured as Modified Asthow Scale more(MAS) than 1+

4. Signed informed consent form

Exclusion Criteria:

1. Patients with marked contractures in the elbow and wrist (MAS>4)

2. Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders

3. Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-Stroke Upper Limb Spasticity
• Stroke

Intervention

Device:
• Shock Wave
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.

Drug:
• Botulinum toxin A
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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of spasticity of elbow	Modified Ashworth Scale (MAS) for spasticity	Between baseline and 4 weeks post-treatment
Secondary	The change of Tardieu scale scores for the elbow and wrist	Tardieu scale scores for spasticity	Between baseline and 1, 4,8 weeks post-treatment
Secondary	The change of upper limb function	The Fugl-Meyer Assessment (FMA) for upper limb function	Between baseline and 1,4,8 weeks post-treatment