None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : ? Study Design
To minimize bias and ensure objectivity in the evaluation, this study employs a double-blind design involving both participants and outcome assessors.
?
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older 2. Shoulder pain persisting for at least 3 months 3. Pain with a visual analog scale (VAS) score of 4 or higher 4. Failure to respond to adequate non-surgical treatment for at least 3 months (including medication, injection therapy, physical therapy, and exercise therapy) 5. Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI) 6. No restrictions on participation in the clinical study procedures, including hospitalization, as determined by the investigator
Exclusion criteria
Exclusion criteria: 1. Individuals who have received subacromial injection therapy in the affected shoulder within the past 3 months. 2. Individuals who have undergone rotator cuff surgery on the affected shoulder within the past 6 months. 3. History of stem cell therapy for the shoulder 4.Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, definite isolated acromioclavicular joint disease, or a clear history of shoulder trauma within the past 3 months 5. Radiographic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or definite findings of acute traumatic rotator cuff injury 6. Individuals with symptomatic cervical spine disorders. 7. Individuals with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia. 8. Study participants with a neurological deficit. 9. Pregnant or breastfeeding individuals. 10. Unwillingness to use effective contraception during the study period (for females: hormonal contraception, intrauterine device [IUD], or intrauterine system [IUS]; for males: vasectomy) 11. Individuals with severe diseases that may affect this clinical study, including cardiovascular, renal, hepatic, endocrine diseases, or malignancies. 12. Individuals who are unable to understand the questionnaires used for assessing study participant conditions, including VAS, or who have communication difficulties due to mental disorders. 13. Unwillingness to participate in the clinical study or inability to comply with the study procedures and follow-up visits 14. Participation in another clinical study within 3 months prior to enrollment in this study 15.Individuals deemed unsuitable for study participation at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Location and size of the rotator cuff tear assessed by magnetic resonance imaging (MRI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Pain And Disability Index score;Constant score;visual analogue scale;Location and size of the rotator cuff tear assessed by arthroscopic examination;Histological examination;Amount and frequency of rescue medication use;Adverse Event;Physical examinations, Vital signs;Clinical lab tests | — |
Countries
Korea, Republic of
Contacts
Public ContactHWANG SERA
Asan Medical Center
Outcome results
None listed