Clinical trial NCT01473277: Botulinum Toxin Type A (BT-A) in Hemiplegic Shoulder Pain Versus Steroid
Official title: Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: The Foundation Institute San Raffaele G. Giglio of Cefalù
Sponsor class: OTHER
Collaborators: name: Ospedale di Brunico
name: Fondazione Salvatore Maugeri
name: IRCCS San Camillo, Venezia, Italy
name: Azienda Ospedaliero, Universitaria Pisana
name: Università degli Studi di Ferrara
First posted: 2011-11-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Therapeutic superiority of BTA respect steroid in HSP, in patients with hemiparesis and shoulder pain due to stroke (ischemic or hemorrhagic).
timeFrame: one year
Secondary outcomes:
measure: Improvement of upper limb functions and activity
timeFrame: one year
measure: Improvement of quality of life
timeFrame: one year
measure: Safety Variables
timeFrame: one year
Other outcomes:
Locations:
city: Cefalù
country: Italy
facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù
state: Palermo
Study officials:
affiliation: San Raffaele-Giglio Foundation
name: Giuseppe Galardi, Dr
role: STUDY_DIRECTOR
References: