Platelet-Rich Plasma for Partial Rotator Cuff Tears (OPTIMISE)

June 15, 2026 updated by: Universidade Nova de Lisboa

Performance of Autologous Platelet-rich Plasma Injection for Tendon Regeneration in Partial Supraspinatus Tears

The goal of this clinical trial is to learn whether platelet-rich plasma (PRP) injection, made from a participant's own blood, can help heal the tendon and improve shoulder symptoms in people with partial tears of the supraspinatus tendon.

The main questions it aims to answer are:

  • Does PRP help the tendon heal?
  • Does PRP improve pain, shoulder movement, daily function, and shoulder magnetic resonance imaging (MRI) findings?

Researchers will compare PRP plus standard of care (physical therapy) to standard of care alone to see if PRP leads to better healing and better clinical results. Researchers will also study if differences in specific biomolecules in PRP are associated with differences in treatment response.

Participants will:

  • receive standard of care treatment, with or without PRP injection depending on the study group
  • have blood collected for PRP preparation
  • have their pain, shoulder movement, and shoulder function assessed
  • undergo shoulder MRI scans
  • be followed over time to measure healing and symptom improvement

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose and rationale:

Rotator cuff injuries are common musculoskeletal injuries and among the most frequent causes of shoulder pain and disability. The mechanisms underlying tendon repair are complex and are promoted by local cell activation, cell migration and proliferation, pro- and anti-inflammatory cytokines and growth factors, extracellular matrix production and reorganization. Growth factors are a key element of tissue regeneration and healing, and several growth factors/cytokines have been applied in osteoarticular conditions, in both animal and human studies. Platelet-rich plasma (PRP) is a platelet concentrate produced from autologous blood sample manipulation that is abundant in growth factors and cytokines with potential regenerative capabilities. The role of PRP in several osteoarticular conditions has been established, but controversy remains in shoulder applications, with recent evidence of benefits in shoulder augmentation surgery for rotator cuff repair. Our study evaluates the performance of autologous PRP injection in partial rotator cuff tears for tendon regeneration as an adjuvant to the standard of care treatments, the relationship of PRP growth factor/cytokine content with clinical efficacy and imaging findings that may predict clinical decision-making, prognostication and treatment response.

Hypothesis and objectives The study hypothesis is that PRP promotes tendon regeneration and clinical improvement in participants with partial supraspinatus tears when added to standard rehabilitation care.

The primary objective is to evaluate the impact of PRP on tendon regeneration and clinical improvement in participants with partial supraspinatus tears, in addition to standard rehabilitation care.

Secondary objectives are:

  1. Evaluate the clinical outcome and imaging changes in patients with partial supraspinatus tears after PRP administration compared to rehabilitation therapy alone;
  2. Evaluate imaging biomarkers for clinical decision-making in patients with partial supraspinatus tears, as well as prognostic and treatment response;
  3. Study the role of different cytokines, growth factors, platelet and leucocyte concentrations in rotator cuff tendon regeneration and clinical outcome after PRP administration;
  4. Study the concentration and patient-to-patient variability of different cytokines and growth factors as well as platelet and leucocyte concentration in PRP formulations.

Study design This is a prospective randomized clinical study with two main pathways and one laboratory component. Participants with clinically and radiologically confirmed partial supraspinatus tendon tears will be recruited after diagnostic evaluation and informed consent. Randomization will be performed after confirmation of eligibility using a computerized minimization algorithm to ensure balance between study groups by sex. Allocation will be implemented by an independent investigator using a secure centralized system.

All participants will receive a standard home-based exercise programme within a rehabilitation protocol. Clinical follow-up will be performed at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months after inclusion, or PRP injection as applicable. Magnetic resonance imaging (MRI) will be performed at baseline during diagnosis and at 3 and 12 months after inclusion.

Task 1: Standard rehabilitation care In Task 1, participants with partial rotator cuff tears will undergo conservative management with physical therapy. The aim of this pathway is to evaluate the clinical course and imaging evolution of participants treated with standard rehabilitation care alone.

Conservative management rehabilitation protocol

A specific rehabilitation protocol is employed by the Sports Medicine team, and is as follows:

In-person session frequency: 2x/week (1st month), 1x/week (2nd month), 2 sessions (3rd month) Total number of sessions: 14 Total duration: 12 weeks Progression criteria: tolerable pain (≤3/10 during exercise, with no worsening lasting >24 h)

In-person sessions:

Each session ~45-60 minutes Warm-up (5-10 min mobility exercises + light resistance band) Main strengthening exercises (20-30 min) Final stretching exercises Patient education and load progression

Rehabilitation Exercise Protocol: MOON Shoulder Group

Outcome measures for this task include clinical and imaging evaluation of the target shoulder, including symptoms, pain duration, traumatic etiology, sleep disturbance, pain intensity measured by the Visual Analog Scale (VAS), pain intensity in the non-target shoulder, Subjective Shoulder Value (SSV), Constant-Murley (CM) score, ultrasound findings, MRI findings, and standard-of-care treatment received.

Task 2: PRP plus standard rehabilitation care In Task 2, participants will undergo percutaneous PRP administration in addition to physical therapy. Autologous PRP will be prepared from peripheral blood collected on the day of injection. A defined volume of freshly prepared PRP (2mL) will be injected at or near the supraspinatus tendon tear within seconds after preparation, and a remaining aliquot will be reserved for cellular and molecular analysis. After injection, the patient will remain for a 30-minute observation period to exclude potential immediate complications, such as fever, chills, pruritus or vaso-vagal reaction. The patient is advised to rest for the first 48h after injection, and use of NSAIDs is prohibited. Participants will be advised to apply an ice pack during the first week after injection. Rescue analgesia with paracetamol 500 mg or paracetamol 375 mg plus tramadol 125 mg up to three times daily will be allowed when needed. Analgesic and anti-inflammatory medication use, including frequency and amount, will be recorded during the first 3 weeks after intervention. Participants will also complete a dedicated 3-month physical rehabilitation programme. Adverse events will be recorded throughout follow-up.

Outcome measures for this task include PRP preparation and administration parameters, including time to injection, extracted and injected dose, injection site, operator, discharge status, complications, time to analysis, cell count, growth factor and cytokine concentrations, pH, and fibrinogen levels. Clinical and imaging evaluation of the target shoulder will also be performed, including symptoms, pain duration, traumatic etiology, sleep disturbance, pain intensity assessed by VAS in both the target and non-target shoulder, SSV, CM score, ultrasound findings, MRI findings, and standard-of-care treatment received.

Task 3: PRP composition and biomarker analysis Task 3 is intended to evaluate the relationship between PRP composition and tendon regeneration or clinical improvement, through detection of interindividual variability in PRP products. After PRP preparation, a small aliquot of each sample will be stored for analysis of cellular composition, pH, fibrinogen, growth factors, and cytokines. These laboratory results will be compared with clinical and imaging outcomes. Samples for cellular quantification will be analysed within 4 hours of preparation. Cell counts and leukocyte subset characterization will be performed by flow cytometry. For molecular analysis, aliquots will be stored at -80°C until batch analysis using bead-based flow assay kits for simultaneous quantification of multiple analytes in a single sample.

Cellular outcomes will include platelet count, white blood cell count, lymphocyte count, monocyte count, neutrophil count, pH, and fibrinogen. Molecular outcomes will include concentrations of vascular endothelial growth factor (VEGF), platelet-derived growth factor AA (PDGF-AA), platelet-derived growth factor BB (PDGF-BB), transforming growth factor beta 1 (TGF-β1), epidermal growth factor (EGF), and fibroblast growth factor (FGF), as well as interleukin-1 receptor antagonist (IL-1Ra), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-10 (IL-10), and interferon gamma (IFN-γ).

Clinical management and contingency plan Participants allocated to conservative treatment will complete a 3-month rehabilitation period, after which treatment response will be reassessed. Treatment failure will be defined as less than a 2-point reduction in VAS pain score and/or less than a 12-point improvement in CM score. In cases of unsuccessful conservative treatment, alternative therapeutic options will be proposed according to best clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: António Proença Caetano, Medical Doctor
  • Phone Number: 00351913746170
  • Email: aprocaetano@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible patients are at least 18 years old, and have clinical (VAS pain score ≥4, loss of >25% in ROM, positive in at least one clinical test such as Jobe, Neer, Drop arm, Hawins-Kennedy, Patte) and imaging findings compatible with partial supraspinatus tear, within 3 months of diagnosis.
  • Patients may have undergone conservative treatments, including lifestyle modification, oral analgesics, or physical therapy, with the exception of shoulder injections.
  • Must be willing to provide consent.

Exclusion Criteria:

  • Patients less than 18 years old
  • Patients with other or concomitant rotator cuff or shoulder muscle/tendon tear(s), complete tears, SLAP tears ≥ grade 2
  • Patients with auto-immune based joint diseases, osteoarthritis (KL grade ≥ 2), adhesive capsulitis, infection, nerve-related conditions, immunocompromised conditions, malignancy, coagulopathy
  • Patients on antiplatelet, anticoagulant, antitumor or immunosuppressive drugs
  • Uncontrolled diabetes, other systemic disorders (hepatitis, rheumatoid arthritis)
  • Pregnancy
  • Shoulder instability
  • Previous shoulder injection or surgery
  • Unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Rehabilitation Care
Participants receive standard conservative management consisting of a home-based exercise programme and physical therapy, with longitudinal clinical and imaging follow-up according to the study schedule.
Experimental: Platelet-Rich Plasma Injection Plus Standard Rehabilitation Care
Participants receive percutaneous autologous platelet-rich plasma (PRP) injection in addition to standard conservative management consisting of a home-based exercise programme and physical therapy, with longitudinal clinical and imaging follow-up according to the study schedule.
Biological: Platelet-Rich Plasma (PRP) Injections
Autologous leucocyte-poor platelet-rich plasma prepared from peripheral blood collected on the day of treatment and administered as a single ultrasound-guided percutaneous injection at or near the partial supraspinatus tendon tear, in addition to standard rehabilitation care. PRP is processed by centrifugation and a residual sample is reserved for cellular and molecular characterization
Other Names:
  • Autologous Platelet-Rich Plasma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Target Shoulder Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups
Pain intensity in the target shoulder will be assessed using the Visual Analog Scale (VAS). The outcome measure is the change in VAS score from baseline to 24 months.
At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes From Baseline in Constant-Murley Score and Subjective Shoulder Value
Time Frame: At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups
Shoulder function and clinical range of motion will be assessed using the Constant-Murley and Subjective Shoulder Value scores. The outcome measure is the change in score from baseline to 12 months.
At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups
Change From Baseline in 12-Item Short Form Survey (SF-12) Mental Health Score
Time Frame: At Diagnosis and 3- and 12-month follow-ups
Health-related quality of life will be assessed using the mental health domain of the 12-Item Short Form Survey (SF-12). The outcome measure is the change in score from baseline to 24 months.
At Diagnosis and 3- and 12-month follow-ups
Change From Baseline in Supraspinatus Tear Size on Magnetic Resonance Imaging (MRI)
Time Frame: At Diagnosis and 3- and 12-month follow-ups
Structural tendon changes will be assessed by T2 mapping on MRI. The outcome measures are the change in supraspinatus tear size and the change in signal intensity from baseline to 12 months.
At Diagnosis and 3- and 12-month follow-ups
Platelet-Rich plasma cell and molecular count
Time Frame: Baseline, immediately after blood collection
Platelet, leukocyte, growth factors, and cytokynes concentrations will be measured in the PRP sample prepared for injection
Baseline, immediately after blood collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Nova de Lisboa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital da Luz, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CES 28/2025 ID785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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