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Clinical Trials/EUCTR2011-004682-32-IT
EUCTR2011-004682-32-IT
Active, not recruiting
Not Applicable

Intra-articular injection of botulinum toxin type A in hemiplegic shoulder pain: a multicentric, double blind randomised, versus steroid study. - BTX-A in HSP

FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO0 sitesMarch 8, 2012
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Conditionshemiplegic shoulder painMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsDYSPORT*SC IM 2FL 500UTRIACORT*INIET 3FL 40MG/1ML

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
hemiplegic shoulder pain
Sponsor
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 8, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO

Eligibility 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.
  • •Age 18\-70 years.
  • •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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 26
  • •F.1\.3 Elderly (\>\=65 years) yes

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.

Outcomes

Primary Outcomes

Not specified

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