Botulinum Toxin Type A (BT-A) in Hemiplegic Shoulder Pain Versus Steroid

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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 will be compared with the intra-articular steroid injection that is the current "gold standard" for the treatment of HSP.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Foundation Institute San Raffaele G. Giglio of Cefalù
• Collaborators: Azienda Ospedaliero, Universitaria Pisana; Fondazione Salvatore Maugeri; IRCCS San Camillo, Venezia, Italy; Ospedale di Brunico; Università degli Studi di Ferrara
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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