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

Primary Purpose

Post-Stroke Elbow Spasticity

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy 60mj
Extracorporeal shock wave therapy 120mj
non extracorporeal shock wave therapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Stroke Elbow Spasticity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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  • Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Sites / Locations

  • Yonsei University Healthcare System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

60mJ ESWT

120mJ ESWT

sham ESWT stimulation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Range of Motion (ROM) of elbow flexor

Secondary Outcome Measures

Full Information

First Posted
January 23, 2015
Last Updated
February 25, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02358005
Brief Title
Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Stroke Elbow Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
60mJ ESWT
Arm Type
Experimental
Arm Description
ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ
Arm Title
120mJ ESWT
Arm Type
Experimental
Arm Description
ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ
Arm Title
sham ESWT stimulation
Arm Type
Placebo Comparator
Arm Description
ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shock wave therapy 60mj
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shock wave therapy 120mj
Intervention Type
Procedure
Intervention Name(s)
non extracorporeal shock wave therapy
Primary Outcome Measure Information:
Title
Range of Motion (ROM) of elbow flexor
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Wook Kim, MD
Phone
+82 -2-2228-3716
Email
YWKIM1@yuhs.ac
Facility Information:
Facility Name
Yonsei University Healthcare System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Wook Kim, MD
Phone
+82 2-2228-3716
Email
YWKIM1@yuhs.ac

12. IPD Sharing Statement

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

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