StrokePhase 2NCT01473277
Botulinum Toxin Type A (BT-A) in Hemiplegic Shoulder Pain Versus Steroid
A Phase 2 study testing BT-A (Dysport 500U), Triamcinolone acetonide in people with Stroke and Hemiparesis, run by The Foundation Institute San Raffaele G. Giglio of Cefalù at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Hemiparesis, Shoulder Pain
- What is being tested?
- BT-A (Dysport 500U), Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, 90015
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hemiparesis, Shoulder Pain
- Being tested
- BT-A (Dysport 500U), Triamcinolone acetonide
- 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
- Medical subject headings
- Stroke, Paresis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-A (Dysport 500U), Triamcinolone acetonideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BT-A (Dysport 500U) | Active comparator | Not described Receives: Drug: BT-A (Dysport 500U), Triamcinolone acetonide |
| Triamcinolone acetonide | Active comparator | Not described Receives: Drug: BT-A (Dysport 500U), Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
Improvement of upper limb functions and activity
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).
Measured: one year
Improvement of quality of life
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).
Measured: one year
Safety Variables
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation Institute San Raffaele G. Giglio of Cefalù
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale di Brunico, Fondazione Salvatore Maugeri, IRCCS San Camillo, Venezia, Italy, Azienda Ospedaliero, Universitaria Pisana, Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Giuseppe Galardi, The Foundation Institute San Raffaele G. Giglio of Cefalù
- Investigators
- Giuseppe Galardi, Dr, Study director, San Raffaele-Giglio Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473277
- Sponsor's protocol ID
- 2011-004682-32
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2011
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study
- ClinicalTrials.gov ID
- NCT01473277
- Acronym / sponsor ID
- 2011-004682-32
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Foundation Institute San Raffaele G. Giglio of CefalùUniversity, hospital or other
- Collaborators
- Ospedale di Brunico, Fondazione Salvatore Maugeri, IRCCS San Camillo, Venezia, Italy, Azienda Ospedaliero, Universitaria Pisana, Università degli Studi di Ferrara
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BT-A (Dysport 500U) | Active comparator | Drug: BT-A (Dysport 500U), Triamcinolone acetonide |
| Triamcinolone acetonide | Active comparator | Drug: BT-A (Dysport 500U), Triamcinolone acetonide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT-A (Dysport 500U), Triamcinolone acetonideAll 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. | Drug | BT-A (Dysport 500U), Triamcinolone acetonide |
Primary outcome
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.
3 secondary outcomes
Improvement of upper limb functions and activity
Time frame: one year
Improvement of quality of life
Time frame: one year
Safety Variables
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Galardi, Dr study director
San Raffaele-Giglio Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BT-A (Dysport 500U), Triamcinolone acetonide in people with Stroke and Hemiparesis, run by The Foundation Institute San Raffaele G. Giglio of Cefalù at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Galardi, Dr (+39 0921 920357, giuseppe.galardi@hsrgiglio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.