Botulinum Toxin A for Shoulder Pain After Stroke

Study Overview
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Brief Summary
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Shoulder pain after stroke is a very common, causing significant morbidity disease. Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural modification. Unfortunately, these therapy methods may not be effective in many patients and long term benefit after treatment is transient, the outcomes may also be incomplete or non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the acetylcholine at the neuromuscular junctions but also other neurotransmitters such as glutamate, substance P and calcitonin gene related peptide, all of which have been indicated in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory shoulder pain after stroke.

Official Title
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The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke.

Conditions
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Stroke, Pain

Intervention / Treatment
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* Drug: Botulinum toxin A
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke patients with pain around the shoulder or lateral deltoid area and deteriorated during active or passive overhead activity; Neer and/or Hawkins tests (+); NRS>5 at rest; Symptoms lasted for at least for 2 months and were unresponsive to analgesic medication or physical therapy for 1 month. Subjects voluntarily sign the informed consent. Age between 18 and 80 years old. - Exclusion Criteria: Received earlier subacromial injections of corticosteroids or botulinuim toxin in the last 6 months; Shoulder fracture, glenohumeral osteoarthritis, bone tumors or osteonecrosis in plain radiographs. Known allergy or sensitivity to study medication or its components. Infection or dermatological condition at the injection sites. Any medical condition that may put the subject at increased risk with exposure , including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function. QTc criteria: QTc ≥ 450 millisecond (msec) or≥480msec for subjects with Bundle Branch Block-values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2xULN; alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function. Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients. Presence of clinically unstable severe cardiovascular, renal or respiratory disease Researchers believe there are other factors unfit to participate in this study of patients. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BoNT-A treatment group<br>Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u); | Drug: Botulinum toxin A<br> <br> * Other names: BoNT-A;|
| Active Comparator: Triamcinolone acetonide treatment group<br>Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml; | Drug: Triamcinolone Acetonide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain score (Numeric Rating Scale, NRS) |  | The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive and/or active shoulder range of motion. |  | The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection. | 
| Change from baseline of should muscle modified Ashworth scale assess (MAS) |  | The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Should pain, Botulinum Toxin