Taichung Veterans General Hospital
Taichung, Taiwan
NCT Number: NCT07789951
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.
This study is active but is not currently recruiting participants.
Notify Me20 year and older
All sexes
Interventional
Not applicable
Taichung, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intralesional injection of PRP lysate
Intralesional injection of hypertonic dextrose
Time frame: before the first injection and one month after the final injection.
Use sono to detect the Rotator cuff tear size
Time frame: 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.
Time frame: 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.
Taichung Veterans General Hospital
Other
Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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