Back to resultsComparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
Primary Purpose
Post-Stroke Upper Limb Spasticity
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shock Wave
Botulinum toxin A
Sponsored by
About this trial
This is an interventional treatment trial for Post-Stroke Upper Limb Spasticity focused on measuring Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin
Eligibility Criteria
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
Sites / Locations
- Mackay Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
shock wave
Botulinum toxin A
Arm Description
The interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
We performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
Outcomes
Primary Outcome Measures
The change of spasticity of elbow
Modified Ashworth Scale (MAS) for spasticity
Secondary Outcome Measures
The change of Tardieu scale scores for the elbow and wrist
Tardieu scale scores for spasticity
The change of upper limb function
The Fugl-Meyer Assessment (FMA) for upper limb function
Full Information
NCT ID
NCT03131791
First Posted
April 21, 2017
Last Updated
August 17, 2018
Sponsor
Mackay Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03131791
Brief Title
Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
Official Title
Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Stroke Upper Limb Spasticity
Keywords
Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A : shock wave, group B: Botulinum Toxin Injection
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
shock wave
Arm Type
Experimental
Arm Description
The interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
Arm Title
Botulinum toxin A
Arm Type
Experimental
Arm Description
We performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
Intervention Type
Device
Intervention Name(s)
Shock Wave
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A
Intervention Description
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 Outcome Measure Information:
Title
The change of spasticity of elbow
Description
Modified Ashworth Scale (MAS) for spasticity
Time Frame
Between baseline and 4 weeks post-treatment
Secondary Outcome Measure Information:
Title
The change of Tardieu scale scores for the elbow and wrist
Description
Tardieu scale scores for spasticity
Time Frame
Between baseline and 1, 4,8 weeks post-treatment
Title
The change of upper limb function
Description
The Fugl-Meyer Assessment (FMA) for upper limb function
Time Frame
Between baseline and 1,4,8 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30392753
Citation
Wu YT, Yu HK, Chen LR, Chang CN, Chen YM, Hu GC. Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2143-2150. doi: 10.1016/j.apmr.2018.05.035. Epub 2018 Jul 4.
Results Reference
derived
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Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
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