Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
NCT07789951 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-08-27
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.
Conditions
- Rotator Cuff Tear
- Rotator Cuff Syndrome
- Rotator Cuff Arthropathy of Right Shoulder
- Rotator Cuff Arthropathy of Left Shoulder
- Rotator Cuff Arthropathy of Bilateral Shoulders
Interventions
- DRUG
-
PRP lysate
Intralesional injection of PRP lysate
- DRUG
-
Hypertonic dextrose
Intralesional injection of hypertonic dextrose
Sponsors & Collaborators
-
Taichung Veterans General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-11
- Primary Completion
- 2026-09-17
- Completion
- 2026-10-01
Countries
- Taiwan
Study Locations
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