- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618603
Botulinum Toxin A for Shoulder Pain After Stroke
November 27, 2015 updated by: TAO WU, Sir Run Run Shaw Hospital
The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke.
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: TAO WU, MD
- Phone Number: 86 571 86006054
- Email: wutao1880@163.com
Study Contact Backup
- Name: JIANHUA LI, MD
- Phone Number: 86 571 86006054
- Email: zjdxsyfkfk@126.com
Study Locations
-
-
Zhejiang
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Hang Zhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital, Medical College of Zhejiang University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BoNT-A treatment group
Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);
|
Other Names:
|
Active Comparator: Triamcinolone acetonide treatment group
Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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)
Time Frame: The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
|
The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee JH, Lee SH, Song SH. Clinical effectiveness of botulinum toxin type B in the treatment of subacromial bursitis or shoulder impingement syndrome. Clin J Pain. 2011 Jul-Aug;27(6):523-8. doi: 10.1097/AJP.0b013e31820e1310.
- McMahon HT, Foran P, Dolly JO, Verhage M, Wiegant VM, Nicholls DG. Tetanus toxin and botulinum toxins type A and B inhibit glutamate, gamma-aminobutyric acid, aspartate, and met-enkephalin release from synaptosomes. Clues to the locus of action. J Biol Chem. 1992 Oct 25;267(30):21338-43.
- Bach-Rojecky L, Salkovic-Petrisic M, Lackovic Z. Botulinum toxin type A reduces pain supersensitivity in experimental diabetic neuropathy: bilateral effect after unilateral injection. Eur J Pharmacol. 2010 May 10;633(1-3):10-4. doi: 10.1016/j.ejphar.2010.01.020. Epub 2010 Feb 1.
- Hsieh LF, Hsu WC, Lin YJ, Wu SH, Chang KC, Chang HL. Is ultrasound-guided injection more effective in chronic subacromial bursitis? Med Sci Sports Exerc. 2013 Dec;45(12):2205-13. doi: 10.1249/MSS.0b013e31829b183c.
- Wu T, Song HX, Dong Y, Li JH. Ultrasound-guided versus blind subacromial-subdeltoid bursa injection in adults with shoulder pain: A systematic review and meta-analysis. Semin Arthritis Rheum. 2015 Dec;45(3):374-8. doi: 10.1016/j.semarthrit.2015.05.011. Epub 2015 May 21.
- Wu T, Fu Y, Song HX, Ye Y, Dong Y, Li JH. Effectiveness of Botulinum Toxin for Shoulder Pain Treatment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2015 Dec;96(12):2214-20. doi: 10.1016/j.apmr.2015.06.018. Epub 2015 Jul 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
November 27, 2015
First Submitted That Met QC Criteria
November 27, 2015
First Posted (Estimate)
December 1, 2015
Study Record Updates
Last Update Posted (Estimate)
December 1, 2015
Last Update Submitted That Met QC Criteria
November 27, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Arthralgia
- Stroke
- Shoulder Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 2016137443 (Other Grant/Funding Number: Medical Science and Technology projects of Zhejiang Provincial Health Department)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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