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

February 25, 2019 updated by: Yonsei University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong Wook Kim, MD
  • Phone Number: +82 -2-2228-3716
  • Email: YWKIM1@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Healthcare System, Severance Hospital
        • Contact:
          • Yong Wook Kim, MD
          • Phone Number: +82 2-2228-3716
          • Email: YWKIM1@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range of Motion (ROM) of elbow flexor
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0925

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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