Status:
UNKNOWN
Botulinum Toxin Type A (BT-A) in Hemiplegic Shoulder Pain Versus Steroid
Lead Sponsor:
The Foundation Institute San Raffaele G. Giglio of Cefalù
Collaborating Sponsors:
Ospedale di Brunico
Fondazione Salvatore Maugeri
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this study is to confirm the efficacy and safety of the intra-articular injection of BT-A in a multicentric double blind randomised study. For this purpose intra-articular injection of BT-A...
Detailed Description
Shoulder pain is one of the most common complications of stroke. In fact, it occurs up to 70% of stroke victims. Post-stroke shoulder pain impacts negatively on daily activities. Moreover, it interfer...
Eligibility Criteria
Inclusion
- Patients with hemiparesis and shoulder pain due to first stroke (ischemic or hemorrhagic) admitted in a rehabilitative department to carry out a standard post-acute rehabilitative program
- Pain score of 45 or greater on a 0-100 mm pain visual analog scale (VAS; 0 = no pain, 100 = worst possible pain)
- Duration of HSP for at least one month
- Pain refractoriness to conventional treatment i.e. common analgesics (such as paracetamol and NSAIDs), slings, strapping and handling of the arm, functional electrical stimulation of shoulder muscles
Exclusion
- Significant spasticity in the upper shoulder joint, defined as a score of 2 or more at the modified Ashworth scale
- History of shoulder pain or shoulder diseases.
- History of neurological diseases (i.e. Parkinson disease, dystonia).
- History of botulinum toxin treatment
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01473277
Start Date
January 1 2012
End Date
January 1 2013
Last Update
November 17 2011
Active Locations (1)
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1
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, Italy, 90015