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

NCT01473277 | Unknown Phase 2 DMC

• 1 other identifier: 2011-004682-32
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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

Keywords

Hemiplegic shoulder pain; Botulinum toxin type A (BT-A); Steroid; Intra-articular injection; Pain score of 45 or greater on a 0-100 mm VAS; Duration of HSP for at least one month; Pain refractoriness to conventional treatment

Outcome Measures

Primary Outcomes (1)

• Therapeutic superiority of BTA respect steroid in HSP, in patients with hemiparesis and shoulder pain due to stroke (ischemic or hemorrhagic).

  The primary efficacy outcome will be the reduction in pain severity, measured by VAS score after 4 weeks of treatment, with respect to baseline evaluation. A difference of about 10 mm between treatments, in the reduction of pain severity, as measured by a VAS scale after 4 weeks, will be considered as clinically significant.

  one year

Secondary Outcomes (3)

• Improvement of upper limb functions and activity

  one year

• Improvement of quality of life

  one year

• Safety Variables

  one year

Study Arms (2)

BT-A (Dysport 500U)

ACTIVE COMPARATOR

Drug: BT-A (Dysport 500U), Triamcinolone acetonide

Triamcinolone acetonide

ACTIVE COMPARATOR

Drug: BT-A (Dysport 500U), Triamcinolone acetonide

Interventions

BT-A (Dysport 500U), Triamcinolone acetonide DRUG

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.

BT-A (Dysport 500U); Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Foundation Institute San Raffaele G. Giglio of Cefalù: lead
• Ospedale di Brunico: collaborator
• Fondazione Salvatore Maugeri: collaborator
• IRCCS San Camillo, Venezia, Italy: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

Fondazione Istituto San Raffaele G. Giglio di Cefalù

Cefalù, Palermo, 90015, Italy

Location

MeSH Terms

Conditions

Stroke; Paresis; Shoulder Pain

Interventions

abobotulinumtoxinA; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Giuseppe Galardi, Dr

  San Raffaele-Giglio Foundation

  STUDY DIRECTOR

Central Study Contacts

Giuseppe Galardi, Dr

CONTACT

+39 0921 920357; giuseppe.galardi@hsrgiglio.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direttore Unità Operativa di Riabilitazione

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 17, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

IT (1)