Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.
Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions
1 other identifier
interventional
80
1 country
1
Brief Summary
Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2023
CompletedFirst Submitted
Initial submission to the registry
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 5, 2025
March 1, 2025
4.9 years
December 20, 2023
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Constant-Murley Shoulder Score (CMSS)
The Constant-Murley Shoulder Score (CMSS) is a multi-item functional scale assessing pain, ADL, ROM, and strength of the affected shoulder. score: 0-100. The higher score means the function feels good and painless.
before treatment, 4-week, 12-week, 24-week.
Secondary Outcomes (5)
American Shoulder and Elbow Surgeons (ASES) Score
before treatment, 4-week, 12-week, 24-week.
range of motion of shoulder
before treatment, 4-week, 12-week, 24-week.
pain score (VAS)
before treatment, 4-week, 12-week, 24-week.
the change of anatomy
before treatment, 4-week, 12-week, 24-week.
associated complications
before treatment, 4-week, 12-week, 24-week.
Study Arms (4)
PRP+HA
EXPERIMENTAL5mL of PRP+HA
PRP injection
NO INTERVENTION4mL of PRP added 1 mL of lidocaine
Steroid
NO INTERVENTION1 mL of rinderon added 4 mL of lidocaine
PROLOTHERAPHY
EXPERIMENTAL4 mL of 20% dextrose added1 mL lidocaine
Interventions
Eligibility Criteria
You may qualify if:
- A. Shoulder pain for at least 1 months
- B.partial-thickness tear diagnosed by MRI or Echo
- C.age between 20 and 85 years old
You may not qualify if:
- A. inflammatory disease, such as rheumatoid arthritis, SLE, etc.
- B. pregnancy
- C. known malignancy
- D. hematologic disease (or hemoglobin \<10 g/dl, platelet \<150.000 ul)
- E. history of shoulder infection
- F. history of shoulder surgery
- G. prior steroid injection for 3 times or more
- H. full-thickness tear
- I. other shoulder problems, such as osteoarthritis, fracture malunion, etc.
- J. subjects who cannot comply with the protocol of study
- K. The shoulder pain area has been treated with PRP for less than 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tien-Ching Leelead
Study Sites (1)
Kaohsiung Medical University Hospital
Kaohsiung City, Sanmin, 807, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Orthopaedics
Study Record Dates
First Submitted
December 20, 2023
First Posted
February 1, 2024
Study Start
February 17, 2023
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 5, 2025
Record last verified: 2025-03