Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2016-02-29
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BoNT-A treatment group
Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);
Botulinum toxin A
Triamcinolone acetonide treatment group
Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
Triamcinolone Acetonide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin A
Triamcinolone Acetonide
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
\-
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sir Run Run Shaw Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
TAO WU
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sir Run Run Shaw Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016137443
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2016137443
Identifier Type: -
Identifier Source: org_study_id