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NCT Number: NCT06237647

Comparison of Steroid, PRP,and PRP 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.

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Key information

Conditions

Rotator Cuff Lesions

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, Sanmin, 807, Taiwan

Location status: Recruiting

Location contact

Lee Tien-Ching, ph.d.

CONTACT

[email protected]

+886-7-3121101 ext. 2553

About this study

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.

  • Name: Cellular matrix™ PRP-HA
  • Dosage form: Cellular Matrix A-CP-HA Kit (Ref. A-CP-HA-3)
  • Dose(s): 3 mL of platelet-rich plasma (PRP) combined with 2 mL of hyaluronic acid
  • 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
  • Mechanism of action: PRP contains rich growth factors and HA could function as bio-scaffold. They have a synergic effect on tissue repair.
  • Pharmacological category: class III medical device

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid, HA

Dietary Supplement

improve tissue repair

Other names: glucose

Primary outcomes

  1. Constant-Murley Shoulder Score (CMSS)

    Time frame: before treatment, 4-week, 12-week, 24-week.

    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.

Secondary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: before treatment, 4-week, 12-week, 24-week.

    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.

  2. range of motion of shoulder

    Time frame: before treatment, 4-week, 12-week, 24-week.

    ROM: flex, extension, abduction, adduction, internal rotation, external rotation. degree: 0-180. The higher degree means the shoulder rotation extends good and is painless.

  3. pain score (VAS)

    Time frame: before treatment, 4-week, 12-week, 24-week.

    score 0-10. The lower score means the function feels good and painless.

  4. the change of anatomy

    Time frame: before treatment, 4-week, 12-week, 24-week.

    Echo or MRI_Measure the wound size of rotator muscle rupture and confirm whether the wound has healed

  5. associated complications

    Time frame: before treatment, 4-week, 12-week, 24-week.

    infection, surgery, hypertrophic scar, consistent pain, etc. After the trial, the investigators calculate the rate of these complications.

Sponsors and collaborators

Lead sponsor

Tien-Ching Lee

Other

Registry information

Official study title

Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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