Status:
COMPLETED
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Allergan
Conditions:
Post-stroke Shoulder Pain and Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 shoulde...
Detailed Description
Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physi...
Eligibility Criteria
Inclusion
- Post stroke greater than 2 months
- Shoulder pain despite PT/OT interventions
- Weight greater than 88 lbs
- Stable medically
- Spasticity
Exclusion
- Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
- Pregnancy
- Infection or dermatologic conditions at the injection site
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00661089
Start Date
September 1 2003
End Date
February 1 2010
Last Update
November 13 2020
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60302