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

Study Overview
=================
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.

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

Conditions
-----------------
Post-Stroke Upper Limb Spasticity

Intervention / Treatment
-----------------
* Device: Shock Wave
* Drug: Botulinum toxin A


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group A : shock wave, group B: Botulinum Toxin Injection
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shock wave<br>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. | Device: Shock Wave<br>* 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.<br>|
| Experimental: Botulinum toxin A<br>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. | Drug: Botulinum toxin A<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of spasticity of elbow | Modified Ashworth Scale (MAS) for spasticity | Between baseline and 4 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The change of upper limb function | The Fugl-Meyer Assessment (FMA) for upper limb function | Between baseline and 1,4,8 weeks post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin