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

Phase 4
Conditions
Post-Stroke Elbow Spasticity
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

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  • Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Range of Motion (ROM) of elbow flexor5 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yonsei University Healthcare System, Severance Hospital

🇰🇷

Seoul, Korea, Republic of

Yonsei University Healthcare System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Yong Wook Kim, MD
Contact
+82 2-2228-3716
YWKIM1@yuhs.ac

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