Rotator Cuff Arthropathy of Bilateral Shoulders, Rotator Cuff Arthropathy of Left Shoulder, Rotator Cuff Arthropathy of Right Shoulder, Rotator Cuff Syndrome, Rotator Cuff Tear
Conditions
Brief summary
The goal of this clinical trial is to learn whether lyophilized platelet-rich plasma (PRP) lysate can improve shoulder symptoms, shoulder muscle strength, and tendon tear size in adults with partial-thickness rotator cuff tears, compared with hypertonic dextrose prolotherapy. The main questions this study aims to answer are: * Does PRP lysate improve shoulder pain and function in people with partial-thickness rotator cuff tears? * Does PRP lysate improve shoulder internal and external rotation strength? * Does PRP lysate reduce the size of the rotator cuff tendon tear as measured by ultrasound? Researchers will compare PRP lysate with hypertonic dextrose prolotherapy to determine whether the changes in shoulder symptoms, muscle strength, and tendon tear size differ between the two treatments. Participants will be randomly assigned to receive either PRP lysate or hypertonic dextrose. Each participant will receive one ultrasound-guided injection into the partially torn rotator cuff tendon each month for 3 months, for a total of three injections. Participants will complete a questionnaire about shoulder symptoms and function, undergo ultrasound examination of the rotator cuff, and have their shoulder rotation strength measured before the first injection and 1 month after the final injection. Participants assigned to the PRP lysate group will also have blood collected for preparation of the PRP lysate used for their treatment.
Interventions
DRUGPRP lysate
Intralesional injection of PRP lysate
DRUGHypertonic dextrose
Intralesional injection of hypertonic dextrose
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 20 years. * Shoulder pain with a partial-thickness rotator cuff tear confirmed by physical examination and ultrasonography. * Willing and able to provide written informed consent.
Exclusion criteria
* Adhesive capsulitis. * Previous shoulder surgery. * Neuromuscular disease affecting shoulder strength. * Platelet dysfunction. * Thrombocytopenia. * Hypofibrinogenemia. * Acute or chronic infectious disease. * History of chronic liver disease. * Current antiplatelet therapy. * Depression or other psychological problems. * Rheumatological disorders. * Cognitive impairment that would prevent adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sonographic Rotator Cuff Tear Size | before the first injection and one month after the final injection. | Use sono to detect the Rotator cuff tear size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford shoulder score | Before the first intralesional injection and one month after the final intralesional injection. | A 12-item patient-reported instrument that assesses shoulder pain and limitations in daily activities during the previous four weeks. Each item is rated on a 5-point scale, producing a total score of 12-60; higher scores reflect more severe symptoms and greater impairment in shoulder function. |
| Shoulder internal and external rotation torque | before the first injection and one month after the final injection. | Utilizing isokinetic dynamometer (Biodex Multi-Joint System 3; Biodex Medical, New York, NY, USA) to measure Shoulder internal and external rotation torque at different angle. |
Countries
Taiwan
Outcome results
None listed