Rotator Cuff LesionsNCT06237647
Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.
A study testing Hyaluronic acid, HA in people with Rotator Cuff Lesions, run by Tien-Ching Lee at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Rotator Cuff Lesions
- What is being tested?
- Hyaluronic acid, HA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, Sanmin, 807
Lee Tien-Ching, ph.d., +886-7-3121101 ext. 2553, tn916943@gmail.com
About this study
Official title: 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.
Read the 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.
- 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
- Conditions
- Rotator Cuff Lesions
- Being tested
- Hyaluronic acid, HA
- Keywords
- rotator cuff lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid, HADietary supplement
Also called glucose
improve tissue repair
| Study group | Role | What they receive |
|---|---|---|
| PRP+HA | Experimental | 5mL of PRP+HA Receives: Dietary Supplement: Hyaluronic acid, HA |
| PRP injection | No intervention | 4mL of PRP added 1 mL of lidocaine |
| Steroid | No intervention | 1 mL of rinderon added 4 mL of lidocaine |
| PROLOTHERAPHY | Experimental | 4 mL of 20% dextrose added1 mL lidocaine Receives: Dietary Supplement: Hyaluronic acid, HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before treatment, 4-week, 12-week, 24-week.
Secondary outcomes (5)
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.
Measured: 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.
Measured: before treatment, 4-week, 12-week, 24-week.
pain score (VAS)
score 0-10. The lower score means the function feels good and painless.
Measured: 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
Measured: 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.
Measured: before treatment, 4-week, 12-week, 24-week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start17 Feb 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tien-Ching Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tien-Ching Lee, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237647
- Sponsor's protocol ID
- RCT-002
- Status last verified
- Mar 2025
- First submitted
- 20 Dec 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT06237647
- Acronym / sponsor ID
- RCT-002
- Conditions
- Rotator Cuff Lesions
- Keywords
- rotator cuff lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tien-Ching LeeUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRP+HA | Experimental | Dietary Supplement: Hyaluronic acid, HA5mL of PRP+HA |
| PRP injection | No intervention | –4mL of PRP added 1 mL of lidocaine |
| Steroid | No intervention | –1 mL of rinderon added 4 mL of lidocaine |
| PROLOTHERAPHY | Experimental | Dietary Supplement: Hyaluronic acid, HA4 mL of 20% dextrose added1 mL lidocaine |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid, HAAlso: glucoseimprove tissue repair | Dietary supplement | PROLOTHERAPHY, PRP+HA |
Primary outcome
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.
5 secondary outcomes
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: before treatment, 4-week, 12-week, 24-week.
range of motion of shoulder
Time frame: before treatment, 4-week, 12-week, 24-week.
pain score (VAS)
Time frame: before treatment, 4-week, 12-week, 24-week.
the change of anatomy
Time frame: before treatment, 4-week, 12-week, 24-week.
associated complications
Time frame: before treatment, 4-week, 12-week, 24-week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid, HA in people with Rotator Cuff Lesions, run by Tien-Ching Lee at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Shoulder Score (CMSS) (time frame: before treatment, 4-week, 12-week, 24-week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.