Status:
COMPLETED
The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A
Lead Sponsor:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Conditions:
Shoulder Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Stroke is the leading cause of disability in developed countries, and the major cause of mortality in Brazil.It is associated with low quality of life, disability, decreased muscle strength and contro...
Detailed Description
The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale) with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis major and subsca...
Eligibility Criteria
Inclusion
- Spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke;
- Diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance;
- Agreement of the patient, family member and / or responsible caregiver to participate in the study.
Exclusion
- Pain before stroke in shoulder affected by hemiplegia;
- Previous treatment using TXB-A for painful shoulder;
- Cognitive impairment that hinders assessment and collaboration with treatment;
- Counter indication to the botulinum toxin use; Structured joint deformity in the shoulder affected by pain
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04470401
Start Date
June 5 2019
End Date
March 5 2021
Last Update
September 21 2021
Active Locations (1)
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1
Santa Casa SP
São Paulo, São Paulo, Brazil, 09040330