Rotator Cuff TearNCT07789951
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
A study testing PRP lysate and Hypertonic dextrose in people with Rotator Cuff Tear and Rotator Cuff Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Syndrome, Rotator Cuff Arthropathy of Right Shoulder
- What is being tested?
- PRP lysate and Hypertonic dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2022to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 20 years.
- Shoulder pain with a partial-thickness rotator cuff tear confirmed by physical examination and ultrasonography.
- Willing and able to provide written informed consent.
Who cannot join
- Adhesive capsulitis.
- Previous shoulder surgery.
- Neuromuscular disease affecting shoulder strength.
- Platelet dysfunction.
- Thrombocytopenia.
- Hypofibrinogenemia.
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- Acute or chronic infectious disease.
- History of chronic liver disease.
- Current antiplatelet therapy.
- Depression or other psychological problems.
- Rheumatological disorders.
- Cognitive impairment that would prevent adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear
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:
Read more
- 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
- Being tested
- PRP lysate, Hypertonic dextrose
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP lysateDrug
Intralesional injection of PRP lysate
Hypertonic dextroseDrug
Intralesional injection of hypertonic dextrose
| Study group | Role | What they receive |
|---|---|---|
| PRP lysate | Experimental | Intralesional injection of PRP lysate Receives: Drug: PRP lysate |
| Hypertonic dextrose | Active comparator | Intralesional injection of hypertonic dextrose Receives: Drug: Hypertonic dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic Rotator Cuff Tear Size
Use sono to detect the Rotator cuff tear size
Measured: before the first injection and one month after the final injection.
Secondary outcomes (2)
Oxford shoulder score
A 12-item patient-reported instrument that assesses shoulder pain and limitations in daily activities during the previous four weeks. Each item is rated on a 5-point scale, producing a total score of 12-60; higher scores reflect more severe symptoms and greater impairment in shoulder function.
Measured: Before the first intralesional injection and one month after the final intralesional injection.
Shoulder internal and external rotation torque
Utilizing isokinetic dynamometer (Biodex Multi-Joint System 3; Biodex Medical, New York, NY, USA) to measure Shoulder internal and external rotation torque at different angle.
Measured: before the first injection and one month after the final injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start11 Mar 2022
- Primary completion17 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789951
- Sponsor's protocol ID
- TCVGH-SF21438B
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazzarini SG, Buraschi R, Pollet J, Bettariga F, Pancera S, Pedersini P. Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2025 Mar 3;105(3):pzaf006. doi: 10.1093/ptj/pzaf006.
PubMed 39836429Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, Barker KL, Gray A, Lamb SE; GRASP Trial Group. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 x 2 factorial, randomised controlled trial. Lancet. 2021 Jul 31;398(10298):416-428. doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12.
PubMed 34265255Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. doi: 10.1097/BLO.0b013e31802fc175.
PubMed 17179786
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT07789951
- Acronym / sponsor ID
- TCVGH-SF21438B
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 17 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 27 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP lysate | Experimental | Drug: PRP lysateIntralesional injection of PRP lysate |
| Hypertonic dextrose | Active comparator | Drug: Hypertonic dextroseIntralesional injection of hypertonic dextrose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 20 years.
- Shoulder pain with a partial-thickness rotator cuff tear confirmed by physical examination and ultrasonography.
- Willing and able to provide written informed consent.
Key exclusion criteria (12 listed)
- Adhesive capsulitis.
- Previous shoulder surgery.
- Neuromuscular disease affecting shoulder strength.
- Platelet dysfunction.
- Thrombocytopenia.
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 |
|---|---|---|
| PRP lysateIntralesional injection of PRP lysate | Drug | PRP lysate |
| Hypertonic dextroseIntralesional injection of hypertonic dextrose | Drug | Hypertonic dextrose |
Primary outcome
Sonographic Rotator Cuff Tear Size
Time frame: before the first injection and one month after the final injection.
Use sono to detect the Rotator cuff tear size
2 secondary outcomes
Oxford shoulder score
Time frame: Before the first intralesional injection and one month after the final intralesional injection.
Shoulder internal and external rotation torque
Time frame: before the first injection and one month after the final injection.
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 22 Oct 2026.
- Results publication: PubMed 39836429Lazzarini SG, Buraschi R, Pollet J, Bettariga F, Pancera S, Pedersini P. Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2025 Mar 3;105(3):pzaf006. doi: 10.1093/ptj/pzaf006.
- Results publication: PubMed 34265255Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, Barker KL, Gray A, Lamb SE; GRASP Trial Group. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 x 2 factorial, randomised controlled trial. Lancet. 2021 Jul 31;398(10298):416-428. doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12.
- Results publication: PubMed 17179786Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. doi: 10.1097/BLO.0b013e31802fc175.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP lysate and Hypertonic dextrose in people with Rotator Cuff Tear and Rotator Cuff Syndrome, run by Taichung Veterans General Hospital 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 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic Rotator Cuff Tear Size (time frame: before the first injection and one month after the final injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07789951, which also lists 3 linked publications.
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 22 Oct 2026.