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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Lesions
• Intervention / Treatment: Dietary supplement: Hyaluronic acid, HA

Detailed Description

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.

1. Name: Cellular matrix™ PRP-HA
2. Dosage form: Cellular Matrix A-CP-HA Kit (Ref. A-CP-HA-3)
3. Dose(s): 3 mL of platelet-rich plasma (PRP) combined with 2 mL of hyaluronic acid
4. Dosing schedule: one injection. After collecting 6 mL of blood collection and then centrifugation for 5 minutes, the PRP with a platelet concentration 1.5-1.6 times higher than the baseline in blood, deprived of contamination with red and white blood cells, entrapped in a 3D network of HA
5. Mechanism of action: PRP contains rich growth factors and HA could function as bio-scaffold. They have a synergic effect on tissue repair.
6. Pharmacological category: class III medical device

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Sanmin
    • Kaohsiung, Sanmin, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University Hospital
      • Contact: Lee Tien-Ching, ph.d.; Phone Number: 2553 +886-7-3121101; Email: tn916943@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP+HA; 5mL of PRP+HA	Dietary supplement: Hyaluronic acid, HA; improve tissue repair; Other Names: glucose
No Intervention: PRP injection; 4mL of PRP added 1 mL of lidocaine
No Intervention: Steroid; 1 mL of rinderon added 4 mL of lidocaine
Experimental: PROLOTHERAPHY; 4 mL of 20% dextrose added1 mL lidocaine	Dietary supplement: Hyaluronic acid, HA; improve tissue repair; Other Names: glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) Score	The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was created by the Society of the American Shoulder and Elbow Surgeons in 1994 as a tool that applies to all shoulder diagnoses. score: 0-100. The higher score means the function feels good and painless.	before treatment, 4-week, 12-week, 24-week.
range of motion of shoulder	ROM: flex, extension, abduction, adduction, internal rotation, external rotation. degree: 0-180. The higher degree means the shoulder rotation extends good and is painless.	before treatment, 4-week, 12-week, 24-week.
pain score (VAS)	score 0-10. The lower score means the function feels good and painless.	before treatment, 4-week, 12-week, 24-week.
the change of anatomy	Echo or MRI_Measure the wound size of rotator muscle rupture and confirm whether the wound has healed	before treatment, 4-week, 12-week, 24-week.
associated complications	infection, surgery, hypertrophic scar, consistent pain, etc. After the trial, the investigators calculate the rate of these complications.	before treatment, 4-week, 12-week, 24-week.

Collaborators and Investigators

• Sponsor: Tien-Ching Lee

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: rotator cuff lesions
• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: RCT-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No