Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Detailed Description
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Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations. Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments. .

Official Title
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A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity

Conditions
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Post-stroke Shoulder Pain and Spasticity

Intervention / Treatment
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* Drug: Botulinum Toxin Type A - OnabotulinumtoxinA
* Drug: Placebo (Saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post stroke greater than 2 months Shoulder pain despite PT/OT interventions Weight greater than 88 lbs Stable medically Spasticity Exclusion Criteria: Myasthenia gravis or other medical conditions that preclude use of botulinum toxin Pregnancy Infection or dermatologic conditions at the injection site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramuscular OnabotulinumtoxinA<br>Injection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit | Drug: Botulinum Toxin Type A - OnabotulinumtoxinA<br>* 100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.<br>* Other names: BOTOX;|
| Active Comparator: Intramuscular Placebo (Saline)<br>Injection of saline into specified shoulder muscles at Visit 2. Blind broken and subjects were offered study drug if initially in the placebo group, at week 12 | Drug: Placebo (Saline)<br>* Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Rating From Baseline to Four Weeks | Change scores from patient ratings on the Visual Analogue Scale on 101 mm scale for worst pain, averaged over a week. Ratings performed at baseline and week four. Scale range 0-100 mm. Minimum value 0= No pain, Maximum value 100= worst pain Higher score indicates worse outcome | baseline and four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disability Assessment Scale for Hygiene | Subject rating of scores on the Disability Assessment Scale Range 0-3, Minimum value 0= no disability, Maximum value 3= severe disability Higher Score indicates worse outcome | baseline and 4 weeks post injection | 
| Time to Don a Pull Over Shirt |  | 2,4,12, and 16 weeks | 
| Ability to Perform Hygiene Rating |  | 2,4,12, and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, shoulder pain, spasticity