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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Giuseppe Galardi, The Foundation Institute San Raffaele G. Giglio of Cefalù.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473277
First Posted: November 17, 2011
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ospedale di Brunico
Fondazione Salvatore Maugeri
IRCCS San Camillo, Venezia, Italy
Azienda Ospedaliero, Universitaria Pisana
Università degli Studi di Ferrara
Information provided by (Responsible Party):
Giuseppe Galardi, The Foundation Institute San Raffaele G. Giglio of Cefalù
November 7, 2011
November 17, 2011
November 17, 2011
January 2012
June 2012   (Final data collection date for primary outcome measure)
Therapeutic superiority of BTA respect steroid in HSP, in patients with hemiparesis and shoulder pain due to stroke (ischemic or hemorrhagic). [ Time Frame: one year ]

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.

Same as current
No Changes Posted
  • Improvement of upper limb functions and activity [ Time Frame: one year ]
    The secondary efficacy outcome will include the following measures: VAS score at the other time points of the study (1 week, 2 weeks, 3 months and 6 months after the treatment), Shoulder Pain and Disability Index (SPADI), Modified Ashworth Scale (MAS), Fugl Meyer Assessment Scale (FMAS), NIH Stroke Scale index (NISS), Functional Independent Measure (FIM), quality of life on short-form (SF)-36 subscales (SF-36).
  • Improvement of quality of life [ Time Frame: one year ]
    The secondary efficacy outcome will include the following measures: VAS score at the other time points of the study (1 week, 2 weeks, 3 months and 6 months after the treatment), Shoulder Pain and Disability Index (SPADI), Modified Ashworth Scale (MAS), Fugl Meyer Assessment Scale (FMAS), NIH Stroke Scale index (NISS), Functional Independent Measure (FIM), quality of life on short-form (SF)-36 subscales (SF-36).
  • Safety Variables [ Time Frame: one year ]

    Safety will be assessed through the collection of adverse events (AEs) and changes in the strength of the deltoid, trapezium, biceps and triceps muscles.

    All treated patients, no matter the duration of treatment, will be considered for the safety analysis.

    Adverse events will be fully described and presented in frequency tables whereas changes in the strength of abovementioned muscles will be summarised by descriptive statistics (mean, standard deviation, minimum and maximum), for the two treatment groups.

Same as current
Not Provided
Not Provided
 
Botulinum Toxin Type A (BT-A) in Hemiplegic Shoulder Pain Versus Steroid
Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study
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.
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 interferes with the rehabilitation process, is related to poor quality of life and has been associated to a worse outcome and to prolonged hospitalization.The aetiology of post-stroke HSP is uncertain, although it has been associated with various factors: joint disorders, capsulitis adhesive, subluxation of the head of the humerus, rotator cuff tendons injuries and spasticity of surrounding muscles. Clinicians use a wide variety of approaches to treat post-stroke HSP, although none has yet been proven effective. Correct positioning and careful handling of the hemiplegic limb are believed to prevent HSP. Physiotherapy alone does not seem to be effective for this complication. Capsulitis adhesive can be successfully treated with corticosteroid injections in the shoulder. However, despite many randomized controlled trials of corticosteroid injections for shoulder pain, their effects remain controversial. The large number of interventions and the lack of consensus about their effectiveness suggest that the aetiology is poorly understood and hence its treatment remains to be established. Intramuscular injections of botulinum toxin type A (BT-A) have also been demonstrated to reduce HSP. The mechanism whereby intramuscular inoculation of BT-A reduces pain may include a muscle relaxant effect and inhibition of the release of neurotransmitters by sensory neurons. Nevertheless, this approach has some limitations: it is probably more effective in muscular than in articular pain and it may be influenced by the muscles affected and site of injection. Intra-articular injection of BT-A has recently proven safe and effective in the treatment of refractory joint shoulder pain caused by chronic arthritis. The mechanisms by which it exerts this effect are not known, but could include inhibition of the release of pain peptides from nerve terminals and sensory ganglia, and anti-inflammatory and anti-glutaminergic effects.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Stroke
  • Hemiparesis
  • Shoulder Pain
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.
  • Active Comparator: BT-A (Dysport 500U)
    Intervention: Drug: BT-A (Dysport 500U), Triamcinolone acetonide
  • Active Comparator: Triamcinolone acetonide
    Intervention: Drug: BT-A (Dysport 500U), Triamcinolone acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
52
January 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01473277
2011-004682-32
Yes
Not Provided
Not Provided
Giuseppe Galardi, The Foundation Institute San Raffaele G. Giglio of Cefalù
The Foundation Institute San Raffaele G. Giglio of Cefalù
  • Ospedale di Brunico
  • Fondazione Salvatore Maugeri
  • IRCCS San Camillo, Venezia, Italy
  • Azienda Ospedaliero, Universitaria Pisana
  • Università degli Studi di Ferrara
Study Director: Giuseppe Galardi, Dr San Raffaele-Giglio Foundation
The Foundation Institute San Raffaele G. Giglio of Cefalù
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP