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TendinopathyPhase 4NCT05603468

Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair

A Phase 4 study testing platelet rich plasma, Corticosteroid and Normal saline in people with Tendinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Tendinopathy
What is being tested?
platelet rich plasma, Corticosteroid and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
387 participants
Where
1 siteChina
Study dates
15 Dec 2022to 31 Dec 2027
Phase
Phase 4
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rotator cuff tears were diagnosis by magnetic resonance imaging or arthroscopy
  • Surgical intervention of rotator cuff tears was proposed.
  • Simple full-layer tear of supraspinatus tendon.
  • Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP

Who cannot join

  • Patients with rotator cuff injuries involving infraspinatus, subscapularis, and teres minor tendon injuries
  • Patients platelet concentration is lower than 100×109
  • Patients have other shoulder diseases, including osteoarthritis, cervical spondylosis, etc.patients have inflammatory diseases, including rheumatoid arthritis, fibromyalgia, rheumatic polymyalgia, etc.patients have received injection treatment within 3 months.
  • Patients have participated in clinical trials or are conducting other clinical trials within 3 months before screening.
  • Patients have severe primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that it is not suitable to be selected.
  • Patients have severe liver, kidney and hematological lesions, such as kidney function exceeding the upper limit of normal value and liver function exceeding 2 times the upper limit of normal value.
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  • Patients have viral hepatitis, infectious diseases, severe abnormalities in blood coagulation and other diseases that the researchers consider unsuitable for surgery.
  • Women who are pregnant or lactating, or who plan to conceive during follow-up, those who are positive for human chorionic gonadotropin before sampling; menstrual women should wait for surgery after the end of menstruation.
  • Patients have severe neurological and mental disorders.
  • Patients suspect or do have a history of alcohol or drug abuse.
  • Patients have height body mass index (BMI) > 30.
  • Patients have tendon disease caused by systemic immune or other diseases, and patients with diseases or symptoms that may affect pain or function scores.
  • Patients have coagulation disorders caused by any other acute or chronic disease.
  • MRI detection of contraindications. Include, but are not limited to: installation of pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug infusion devices implanted in the body, any electronic devices implanted in the body (nerve stimulators, bone growth stimulators), endovascular embolization steel rings, filters, ECG recording monitors, metal sutures, shrapnel or iron particles in the body, fixation of steel plates and nails after fracture surgery, Cochlear implant, middle ear graft, intraocular metal foreign body, etc. Claustrophobia, critically ill patients, etc.
  • Refer to the April 2008 edition of the Law of the people's Republic of China on the Protection of disabled Persons, patients belong to the subjects of legal disabled persons
  • Other situations in which the researchers judged that the subjects were not suitable to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310058

Other trials in China

About this study

Official title: Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial

Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy

Read the detailed description

This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.

Conditions
Tendinopathy
Being tested
platelet rich plasma, Corticosteroid, Normal saline
Keywords
Tendinopathy, Platelet Rich Plasma
Medical subject headings
Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • platelet rich plasmaDrug

    Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control.

  • CorticosteroidDrug

    Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy.

  • Normal salineDrug

    Normal saline

Study groups in NCT05603468
Study groupRoleWhat they receive
Platelet Rich Plasma groupExperimentalpatients rejected with platelet rich plasma
Receives: Drug: platelet rich plasma
Corticosteroid groupActive comparatorpatients rejected with corticosteroid
Receives: Drug: Corticosteroid
Normal saline groupPlacebo comparatorpatients rejected with normal saline
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxford Shoulder Score (OSS)

    The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.

    Measured: 6months after surgery

Secondary outcomes (12)

  1. Oxford Shoulder Score (OSS)

    The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly

    Measured: 3 months, 1year, and 2years after surgery

  2. Constant-Mulery score(CMS)

    The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.

    The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  3. Fear-avoidance belief questionnaire(FABQ)

    The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  4. Insomnia Severity Index(ISI)

    The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  5. Hospital Anxiety and Depression Scale(HADS)

    HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  6. SF-36

    SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health"

    Measured: 3 months, 6months, 1year, and 2years after surgery

  7. Visual analogue scale(VAS)

    Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  8. range of motion

    Measure the patient's flexion, abduction, internal rotation and external rotation angle

    Measured: 3 months, 6months, 1year, and 2years after surgery

  9. muscle strength

    Use dynamometer to evaluate patient's forward bending, abduction, external rotation and internal rotation strength.

    Measured: 3 months, 6months, 1year, and 2years after surgery

  10. retear rate

    Proportion of the total number of people with retearing after arthroscopic rotator cuff repair

    Measured: 3 months, 6months, 1year, and 2years after surgery

  11. Acromiohumeral distance

    Measurement of acromiohumeral distance based on x-ray

    Measured: 3 months, 6months, 1year, and 2years after surgery

  12. Signal to noise ratio of tendon in MRI

    Measurement of Signal to Noise Ratio of Tendon in MRI based on software

    Measured: 3 months, 6months, 1year, and 2years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start15 Dec 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
387 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05603468
Sponsor's protocol ID
2022-0833
Status last verified
Jan 2026
First submitted
25 Oct 2022
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing platelet rich plasma, Corticosteroid and Normal saline in people with Tendinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 4 inclusion and 16 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 9 Feb 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Oxford Shoulder Score (OSS) (time frame: 6months after surgery). 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 NCT05603468.

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 9 Feb 2026.

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