Platelet-Rich Plasma for Partial Rotator Cuff Tears

NCT07659600 | Not Yet Recruiting

• 1 other identifier: CES 28/2025 ID785
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Partial Supraspinatus Tear; Rotator Cuff Tears (RCTs); Rotator Cuff Injury

Keywords

Platelet-Rich Plasma; Partial Supraspinatus Tears; Rotator Cuff Tears; Autologous PRP; PRP; Shoulder pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Target Shoulder Pain Intensity Measured by Visual Analog Scale (VAS)

  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 Outcomes (4)

• Changes From Baseline in Constant-Murley Score and Subjective Shoulder Value

  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

  At Diagnosis and 3- and 12-month follow-ups

• Change From Baseline in Supraspinatus Tear Size on Magnetic Resonance Imaging (MRI)

  At Diagnosis and 3- and 12-month follow-ups

• Platelet-Rich plasma cell and molecular count

  Baseline, immediately after blood collection

Study Arms (2)

Standard Rehabilitation Care

NO INTERVENTION

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.

Platelet-Rich Plasma Injection Plus Standard Rehabilitation Care

EXPERIMENTAL

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

Interventions

Platelet-Rich Plasma (PRP) Injections BIOLOGICAL

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

Also known as: Autologous Platelet-Rich Plasma

Platelet-Rich Plasma Injection Plus Standard Rehabilitation Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Hospital da Luz, Portugal: collaborator

Related Publications (27)

• Thomopoulos S, Williams GR, Soslowsky LJ. Tendon to bone healing: differences in biomechanical, structural, and compositional properties due to a range of activity levels. J Biomech Eng. 2003 Feb;125(1):106-13. doi: 10.1115/1.1536660.

  PMID: 12661203 BACKGROUND

• Park JY, Lee JH, Oh KS, Chung SW, Choi Y, Yoon WY, Kim DW. Rotator cuff retear after repair surgery: comparison between experienced and inexperienced surgeons. Clin Shoulder Elb. 2021 Sep;24(3):135-140. doi: 10.5397/cise.2021.00073. Epub 2021 Sep 1.

  PMID: 34488293 BACKGROUND

• Majewski M, Heisterbach P, Jaquiery C, Durselen L, Todorov A, Martin I, Evans CH, Muller SA. Improved tendon healing using bFGF, BMP-12 and TGFbeta1 in a rat model. Eur Cell Mater. 2018 Jun 13;35:318-334. doi: 10.22203/eCM.v035a22.

  PMID: 29897097 BACKGROUND

• Rosso C, Morrey ME, Schar MO, Grezda K; Swiss Orthopaedics Shoulder Elbow and Expert Group; Swiss Orthopaedics Shoulder and Elbow Expert Group dagger. The role of platelet-rich plasma in shoulder pathologies: a critical review of the literature. EFORT Open Rev. 2023 Apr 25;8(4):213-222. doi: 10.1530/EOR-22-0104.

  PMID: 37097022 BACKGROUND

• LaPrade RF, Geeslin AG, Murray IR, Musahl V, Zlotnicki JP, Petrigliano F, Mann BJ. Biologic Treatments for Sports Injuries II Think Tank-Current Concepts, Future Research, and Barriers to Advancement, Part 1: Biologics Overview, Ligament Injury, Tendinopathy. Am J Sports Med. 2016 Dec;44(12):3270-3283. doi: 10.1177/0363546516634674. Epub 2016 Mar 29.

  PMID: 27159318 BACKGROUND

• Tanpowpong T, Thepsoparn M, Numkarunarunrote N, Itthipanichpong T, Limskul D, Thanphraisan P. Effects of Platelet-Rich Plasma in Tear Size Reduction in Partial-Thickness Tear of the Supraspinatus Tendon Compared to Corticosteroids Injection. Sports Med Open. 2023 Feb 8;9(1):11. doi: 10.1186/s40798-023-00556-w.

  PMID: 36752928 BACKGROUND

• Somisetty TK, Seenappa H, Das S, Shanthappa AH. Comparing the Efficacy of Intra-articular Platelet-Rich Plasma and Corticosteroid Injections in the Management of Frozen Shoulder: A Randomized Controlled Trial. Cureus. 2023 May 30;15(5):e39728. doi: 10.7759/cureus.39728. eCollection 2023 May.

  PMID: 37398735 BACKGROUND

• Sanchez-Losilla C, Ferre-Aniorte A, Alvarez-Diaz P, Barastegui-Fernandez D, Cugat R, Alentorn-Geli E. Efficacy of platelet-rich plasma in rotator cuff repair: systematic review and meta-analysis. Rev Esp Cir Ortop Traumatol. 2024 May-Jun;68(3):296-305. doi: 10.1016/j.recot.2023.05.014. Epub 2023 Jun 1. English, Spanish.

  PMID: 37270058 BACKGROUND

• Woo SL, Gelberman RH, Cobb NG, Amiel D, Lothringer K, Akeson WH. The importance of controlled passive mobilization on flexor tendon healing. A biomechanical study. Acta Orthop Scand. 1981 Dec;52(6):615-22. doi: 10.3109/17453678108992156.

  PMID: 7331798 BACKGROUND

• Trantos IA, Vasiliadis ES, Giannoulis FS, Pappa E, Kakridonis F, Pneumaticos SG. The Effect of PRP Augmentation of Arthroscopic Repairs of Shoulder Rotator Cuff Tears on Postoperative Clinical Scores and Retear Rates: A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 11;12(2):581. doi: 10.3390/jcm12020581.

  PMID: 36675510 BACKGROUND

• Velasquez Garcia A, Ingala Martini L, Franco Abache A, Abdo G. Role of platelet-rich plasma in the treatment of rotator cuff tendinopathy. World J Orthop. 2023 Jul 18;14(7):505-515. doi: 10.5312/wjo.v14.i7.505. eCollection 2023 Jul 18.

  PMID: 37485430 BACKGROUND

• Adra M, El Ghazal N, Nakanishi H, Smayra K, Hong SS, Miangul S, Matar RH, Than CA, Tennent D. Platelet-rich plasma versus corticosteroid injections in the management of patients with rotator cuff disease: A systematic review and meta-analysis. J Orthop Res. 2023 Jan;41(1):7-20. doi: 10.1002/jor.25463. Epub 2022 Oct 31.

  PMID: 36250611 BACKGROUND

• Jiang X, Zhang H, Wu Q, Chen Y, Jiang T. Comparison of three common shoulder injections for rotator cuff tears: a systematic review and network meta-analysis. J Orthop Surg Res. 2023 Apr 3;18(1):272. doi: 10.1186/s13018-023-03747-z.

  PMID: 37013620 BACKGROUND

• Filardo G, Di Matteo B, Kon E, Merli G, Marcacci M. Platelet-rich plasma in tendon-related disorders: results and indications. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):1984-1999. doi: 10.1007/s00167-016-4261-4. Epub 2016 Sep 24.

  PMID: 27665095 BACKGROUND

• Thomopoulos S, Kim HM, Das R, Silva MJ, Sakiyama-Elbert S, Amiel D, Gelberman RH. The effects of exogenous basic fibroblast growth factor on intrasynovial flexor tendon healing in a canine model. J Bone Joint Surg Am. 2010 Oct 6;92(13):2285-93. doi: 10.2106/JBJS.I.01601.

  PMID: 20926722 BACKGROUND

• Thomopoulos S, Das R, Silva MJ, Sakiyama-Elbert S, Harwood FL, Zampiakis E, Kim HM, Amiel D, Gelberman RH. Enhanced flexor tendon healing through controlled delivery of PDGF-BB. J Orthop Res. 2009 Sep;27(9):1209-15. doi: 10.1002/jor.20875.

  PMID: 19322789 BACKGROUND

• Giusti I, Rughetti A, D'Ascenzo S, Millimaggi D, Pavan A, Dell'Orso L, Dolo V. Identification of an optimal concentration of platelet gel for promoting angiogenesis in human endothelial cells. Transfusion. 2009 Apr;49(4):771-8. doi: 10.1111/j.1537-2995.2008.02033.x. Epub 2008 Dec 23.

  PMID: 19170984 BACKGROUND

• Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.

  PMID: 24932440 BACKGROUND

• Deng D, Wang W, Wang B, Zhang P, Zhou G, Zhang WJ, Cao Y, Liu W. Repair of Achilles tendon defect with autologous ASCs engineered tendon in a rabbit model. Biomaterials. 2014 Oct;35(31):8801-8809. doi: 10.1016/j.biomaterials.2014.06.058. Epub 2014 Jul 25.

  PMID: 25069604 BACKGROUND

• Lu J, Jiang L, Chen Y, Lyu K, Zhu B, Li Y, Liu X, Liu X, Long L, Wang X, Xu H, Wang D, Li S. The Functions and Mechanisms of Basic Fibroblast Growth Factor in Tendon Repair. Front Physiol. 2022 Jun 13;13:852795. doi: 10.3389/fphys.2022.852795. eCollection 2022.

  PMID: 35770188 BACKGROUND

• Subramanian A, Kanzaki LF, Galloway JL, Schilling TF. Mechanical force regulates tendon extracellular matrix organization and tenocyte morphogenesis through TGFbeta signaling. Elife. 2018 Nov 26;7:e38069. doi: 10.7554/eLife.38069.

  PMID: 30475205 BACKGROUND

• Lichtnekert J, Kawakami T, Parks WC, Duffield JS. Changes in macrophage phenotype as the immune response evolves. Curr Opin Pharmacol. 2013 Aug;13(4):555-64. doi: 10.1016/j.coph.2013.05.013. Epub 2013 Jun 7.

  PMID: 23747023 BACKGROUND

• Thomopoulos S, Parks WC, Rifkin DB, Derwin KA. Mechanisms of tendon injury and repair. J Orthop Res. 2015 Jun;33(6):832-9. doi: 10.1002/jor.22806. Epub 2015 Mar 2.

  PMID: 25641114 BACKGROUND

• Zhou T, Han C, Weng X. Present situation and development prospects of the diagnosis and treatment of rotator cuff tears. Front Surg. 2023 Jun 27;10:857821. doi: 10.3389/fsurg.2023.857821. eCollection 2023.

  PMID: 37440927 BACKGROUND

• Lukasiewicz P, McFarland EG, Weber SC. Partial rotator cuff tears: algorithmic approach to treatment. Ann Jt. 2023 Jun 12;8:21. doi: 10.21037/aoj-22-38. eCollection 2023. No abstract available.

  PMID: 38529236 BACKGROUND

• Teunis T, Lubberts B, Reilly BT, Ring D. A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age. J Shoulder Elbow Surg. 2014 Dec;23(12):1913-1921. doi: 10.1016/j.jse.2014.08.001.

  PMID: 25441568 BACKGROUND

• Snedeker JG, Foolen J. Tendon injury and repair - A perspective on the basic mechanisms of tendon disease and future clinical therapy. Acta Biomater. 2017 Nov;63:18-36. doi: 10.1016/j.actbio.2017.08.032. Epub 2017 Sep 1.

  PMID: 28867648 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

António Proença Caetano, Medical Doctor

CONTACT

00351913746170; aprocaetano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Physical therapists, radiologists and data collecting personnel will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, randomized, parallel-group study with 1:1 allocation comparing standard rehabilitation care alone versus autologous platelet-rich plasma (PRP) injection plus standard rehabilitation care in participants with partial supraspinatus tears. Participants remain in their assigned group throughout follow-up.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share