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

NCT01473277 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-11-17

No results posted yet for this study

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.

Conditions

  • Stroke
  • Hemiparesis
  • Shoulder Pain

Interventions

DRUG

BT-A (Dysport 500U), Triamcinolone acetonide

All patients will be randomize to receive an intra-articular injection of BT-A (Dysport 500U) or triamcinolone acetonide (40 mg). Both drugs will be reconstituted with 2.0 ml of saline. Both drugs will be injected in the glenohumeral joint with a standard posterior approach. The time of the intra-articular injection od BT-A or steroid will be considered the "time zero" for each patient. The primary and secondary efficacy variables will be evaluated in all patients at 1 week, 2 weeks, 4 weeks, 3 months and 6 months after the treatment.

Sponsors & Collaborators

  • Ospedale di Brunico

    collaborator UNKNOWN

  • Fondazione Salvatore Maugeri

    collaborator OTHER

  • IRCCS San Camillo, Venezia, Italy

    collaborator OTHER

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Università degli Studi di Ferrara

    collaborator OTHER

  • The Foundation Institute San Raffaele G. Giglio of Cefalù

    lead OTHER

Principal Investigators

  • Giuseppe Galardi, Dr · San Raffaele-Giglio Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2013-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473277 on ClinicalTrials.gov