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Botulinum Toxin A for Shoulder Pain After Stroke

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ClinicalTrials.gov Identifier: NCT02618603
Recruitment Status : Unknown
Verified November 2015 by TAO WU, Sir Run Run Shaw Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2015
Last Update Posted : December 1, 2015
Sponsor:
Information provided by (Responsible Party):
TAO WU, Sir Run Run Shaw Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Pain Drug: Botulinum toxin A Drug: Triamcinolone Acetonide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke.
Study Start Date : February 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BoNT-A treatment group
Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);
Drug: Botulinum toxin A
Other Name: BoNT-A

Active Comparator: Triamcinolone acetonide treatment group
Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
Drug: Triamcinolone Acetonide



Primary Outcome Measures :
  1. Change from baseline of pain score (Numeric Rating Scale, NRS) [ Time Frame: The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection. ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stroke patients with pain around the shoulder or lateral deltoid area and deteriorated during active or passive overhead activity;
  2. Neer and/or Hawkins tests (+);
  3. NRS>5 at rest;
  4. Symptoms lasted for at least for 2 months and were unresponsive to analgesic medication or physical therapy for 1 month.
  5. Subjects voluntarily sign the informed consent.
  6. Age between 18 and 80 years old. -

Exclusion Criteria:

  1. Received earlier subacromial injections of corticosteroids or botulinuim toxin in the last 6 months;
  2. Shoulder fracture, glenohumeral osteoarthritis, bone tumors or osteonecrosis in plain radiographs.
  3. Known allergy or sensitivity to study medication or its components.
  4. Infection or dermatological condition at the injection sites.
  5. 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.
  6. 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
  7. 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%).
  8. Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
  9. Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
  10. Presence of clinically unstable severe cardiovascular, renal or respiratory disease
  11. Researchers believe there are other factors unfit to participate in this study of patients.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618603


Contacts
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Contact: TAO WU, MD 86 571 86006054 wutao1880@163.com
Contact: JIANHUA LI, MD 86 571 86006054 zjdxsyfkfk@126.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital, Medical College of Zhejiang University
Hang Zhou, Zhejiang, China, 310016
Sponsors and Collaborators
Sir Run Run Shaw Hospital

Publications of Results:

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Responsible Party: TAO WU, MD, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT02618603     History of Changes
Other Study ID Numbers: 2016137443
2016137443 ( Other Grant/Funding Number: Medical Science and Technology projects of Zhejiang Provincial Health Department )
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: December 1, 2015
Last Verified: November 2015
Keywords provided by TAO WU, Sir Run Run Shaw Hospital:
Stroke
Should pain
Botulinum Toxin
Additional relevant MeSH terms:
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Shoulder Pain
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Triamcinolone diacetate
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids