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

NCT ID: NCT03131791

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-09-30

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.

Conditions

Post-Stroke Upper Limb Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shock Wave

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

Botulinum toxin A

Intervention Type: DRUG

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.

Interventions

Shock Wave

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: DEVICE

Botulinum toxin A

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gwo-Chi Hu,PHD

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 30392753 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16MMHIS066e

Identifier Type: -

Identifier Source: org_study_id