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

Phase 4

• Conditions: Post-Stroke Elbow Spasticity
• Interventions: Procedure: Extracorporeal shock wave therapy 120mj; Procedure: non extracorporeal shock wave therapy; Procedure: Extracorporeal shock wave therapy 60mj

• Registration Number: NCT02358005
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-23
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
120mJ ESWT	Extracorporeal shock wave therapy 120mj	ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ
sham ESWT stimulation	non extracorporeal shock wave therapy	ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ
60mJ ESWT	Extracorporeal shock wave therapy 60mj	ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ

Primary Outcome Measures

Name	Time	Method
Range of Motion (ROM) of elbow flexor	5 weeks

Trial Locations

Locations (1)

Yonsei University Healthcare System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of