Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

Post-Stroke Elbow Spasticity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02358005
• Other study ID #: 4-2014-0925
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: August 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: Yong Wook Kim, MD
• Phone: +82 -2-2228-3716
• Email: YWKIM1[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• Age =20 years

• inpatients

• Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii

• Modified Ashworth scale (MAS) =2,

• At least a 3-month period from stroke,

• Written informed consent has been obtained

Exclusion Criteria:

• Fixed contractures and/or deformities at the elbow,

• Previous fractures of the paretic upper limb,

• Peripheral nervous system disorders/myopathies,

• Previous BTX-A treatment and/or ESWT,

• Structural alterations in the soft tissue (e.g., fibrosis),

• Known allergy or sensitivity to the study medication or its components

• Presence of an unstable medical condition or uncontrolled systemic disease

• Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.

• Bleeding tendency and/or anticoagulation therapy

• Presence of infection or skin disorder at injection sites

• Females were are pregnant, nursing, or are planning a pregnancy during the study

• Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception

• Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-Stroke Elbow Spasticity
• Stroke

Intervention

Procedure:
• Extracorporeal shock wave therapy 60mj

• Extracorporeal shock wave therapy 120mj

• non extracorporeal shock wave therapy

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Healthcare System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion (ROM) of elbow flexor		5 weeks