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Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity

NCT00661089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-11-13

Study results available
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Summary

The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Conditions

  • Post-stroke Shoulder Pain and Spasticity

Interventions

DRUG

Botulinum Toxin Type A - OnabotulinumtoxinA

100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.

DRUG

Placebo (Saline)

Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Christina Marciniak, MD · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2009-03-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661089 on ClinicalTrials.gov