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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by The Foundation Institute San Raffaele G. Giglio of Cefalù.
Recruitment status was  Not yet recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01473277
First received: November 7, 2011
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiparesis
Shoulder Pain
Drug: BT-A (Dysport 500U), Triamcinolone acetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study

Resource links provided by NLM:


Further study details as provided by The Foundation Institute San Raffaele G. Giglio of Cefalù:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Improvement of upper limb functions and activity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 52
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BT-A (Dysport 500U) 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: Triamcinolone acetonide 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473277

Contacts
Contact: Giuseppe Galardi, Dr +39 0921 920357 giuseppe.galardi@hsrgiglio.it

Locations
Italy
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, Italy, 90015
Sponsors and Collaborators
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
Investigators
Study Director: Giuseppe Galardi, Dr San Raffaele-Giglio Foundation
  More Information

No publications provided

Responsible Party: Giuseppe Galardi, Direttore Unità Operativa di Riabilitazione, The Foundation Institute San Raffaele G. Giglio of Cefalù
ClinicalTrials.gov Identifier: NCT01473277     History of Changes
Other Study ID Numbers: 2011-004682-32
Study First Received: November 7, 2011
Last Updated: November 14, 2011
Health Authority: Italy: The Italian Medicines Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by The Foundation Institute San Raffaele G. Giglio of Cefalù:
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

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Dyskinesia Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014