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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Post-Stroke Elbow Spasticity

Treatments: Procedure: Extracorporeal shock wave therapy 120mj; Procedure: Extracorporeal shock wave therapy 60mj; Procedure: non extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02358005

4-2014-0925

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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• Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

60mJ ESWT

Experimental group

Description:

ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ

Treatment:

Procedure: Extracorporeal shock wave therapy 60mj

120mJ ESWT

Experimental group

Description:

ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ

Treatment:

Procedure: Extracorporeal shock wave therapy 120mj

sham ESWT stimulation

Placebo Comparator group

Description:

ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ

Treatment:

Procedure: non extracorporeal shock wave therapy