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

Not Applicable

Completed

• Conditions: Post-Stroke Upper Limb Spasticity
• Interventions: Device: Shock Wave; Drug: Botulinum toxin A

• Registration Number: NCT03131791
• Lead Sponsor: Mackay Memorial Hospital

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2017-07-01
• Study Completion: 2017-09-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shock wave	Shock Wave	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.
Botulinum toxin A	Botulinum toxin A	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.

Primary Outcome Measures

Name	Time	Method
The change of spasticity of elbow	Between baseline and 4 weeks post-treatment	Modified Ashworth Scale (MAS) for spasticity

Secondary Outcome Measures

Name	Time	Method
The change of Tardieu scale scores for the elbow and wrist	Between baseline and 1, 4,8 weeks post-treatment	Tardieu scale scores for spasticity
The change of upper limb function	Between baseline and 1,4,8 weeks post-treatment	The Fugl-Meyer Assessment (FMA) for upper limb function

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan