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

Mackay Memorial Hospital42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-Stroke Upper Limb Spasticity

Interventions

Shock WaveDEVICE

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 ADRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mackay Memorial Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

The change of spasticity of elbow

Modified Ashworth Scale (MAS) for spasticity

Time frame: Between baseline and 4 weeks post-treatment

Secondary Outcomes

The change of Tardieu scale scores for the elbow and wrist

Tardieu scale scores for spasticity

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

The change of upper limb function

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

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

Data from ClinicalTrials.gov

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