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

Mackay Memorial Hospital

Status: Completed

Conditions: Post-Stroke Upper Limb Spasticity

Treatments: Device: Shock Wave; Drug: Botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT03131791

16MMHIS066e

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

shock wave

Experimental group

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.

Treatment:

Device: Shock Wave

Botulinum toxin A

Experimental group

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.

Treatment:

Drug: Botulinum toxin A