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Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy

14 juli 2026 bijgewerkt door: Tomasz Wnuk, MD, PhD, Ortonika Orthopedic Medical Clinic in Lublin

Comparative Analysis of the Efficacy of Hyaluronic Acid and Platelet-Rich Plasma Injections in the Treatment of Chronic Tendinopathies and Enthesopathies: A Prospective, Randomized Comparative Study

Chronic tendinopathies and enthesopathies are common musculoskeletal conditions in orthopedics and sports medicine, frequently leading to pain, impaired function, and significantly reduced quality of life. Their pathogenesis involves tissue degeneration and ineffective repair response, often without an active inflammatory process.

Standard conservative management based on physiotherapy and activity modification is often prolonged and not always satisfactory. Minimally invasive injectable interventions supporting tendon and enthesis regeneration represent a promising alternative due to their favorable safety profile and outpatient feasibility.

Hyaluronic acid (HA) is a glycosaminoglycan naturally present in connective tissues. In the context of tendinopathy, it is thought to modulate inflammatory processes, provide mechanical protection by reducing friction and adhesion within the tendon sheath, and support the proper organization of collagen fibers in the tendon matrix.

Platelet-rich plasma (PRP) is an autologous concentrate of platelets providing high local concentrations of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-β), and vascular endothelial growth factor (VEGF), which initiate and support repair processes, cellular proliferation, and angiogenesis.

This prospective, randomized, open-label, two-arm study aims to compare the clinical efficacy of hyaluronic acid (HA) and platelet-rich plasma (PRP) injections in 80 participants with chronic Achilles tendinopathy or medial epicondylopathy of the elbow. Participants will be randomly assigned in a 1:1 ratio to receive either two HA injections or two PRP injections administered two weeks apart under ultrasonographic guidance. Follow-up will continue for 12 months after the second injection. The primary outcomes are the changes from baseline to 6 months in pain intensity measured using a 100-millimeter (mm) Visual Analog Scale (VAS), upper-limb function measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy, and Achilles tendon symptoms and function measured using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The results will provide evidence to support the selection of injectable treatment for chronic tendinopathies and enthesopathies.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Polen
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-841
        • Werving
        • Ortonika Orthopedic Medical Clinic in Lublin
        • Contact:
        • Hoofdonderzoeker:
          • Tomasz Wnuk, MD, PhD
        • Onderonderzoeker:
          • Piotr Przybylski, MD, PhD
        • Onderonderzoeker:
          • Mateusz Matyjaszczyk, MD
        • Onderonderzoeker:
          • Przemysław Golonka, MD
        • Onderonderzoeker:
          • Damian Borys, MD
        • Onderonderzoeker:
          • Beata Krupska, MSc
        • Onderonderzoeker:
          • Emilia Antoniewska, MSc

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Chronic tendinopathy or enthesopathy of the Achilles tendon or tendon insertion in the elbow region (medial epicondylopathy, so-called golfer's elbow)
  • Symptom duration exceeding 3 months
  • Pain intensity of at least 40 millimeters (mm) on a 100-mm Visual Analog Scale (VAS)
  • Age 18-65 years
  • Signed written informed consent

Exclusion Criteria:

  • Previous surgical treatment of the studied tendon or tendon insertion
  • Prior injection of corticosteroids, platelet-rich plasma (PRP), or hyaluronic acid into the area being studied within 3 months before enrollment
  • Active systemic or local infection at the planned injection site
  • Systemic inflammatory or autoimmune disease involving the joints, including rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus
  • Pregnancy or breastfeeding
  • Body mass index (BMI) of 40 kilograms per square meter (kg/m²) or greater

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm 1 - Hyaluronic Acid (HA)
Two peritendinous or intratendinous injections of hyaluronic acid (HA), containing 32 milligrams (mg) of sodium hyaluronate in 2 milliliters (mL) per injection, administered two weeks apart under ultrasonographic guidance.
Apparaat: Hyaluronic acid injection
Assigned to: Arm 1
Experimenteel: Arm 2 - Platelet-Rich Plasma (PRP)
Two peritendinous or intratendinous injections of autologous platelet-rich plasma (PRP), administered two weeks apart under ultrasonographic guidance.
Apparaat: Autologous Platelet-Rich Plasma Injection
Assigned to: Arm 2

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
Tijdsspanne: Baseline and 6 months after the second injection
Pain intensity will be measured using a 100-millimeter (mm) Visual Analog Scale (VAS), ranging from 0 mm, indicating no pain, to 100 mm, indicating the worst imaginable pain. The outcome will be the mean change in VAS score from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Baseline and 6 months after the second injection
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 6 Months
Tijdsspanne: Baseline and 6 months after the second injection
Upper-limb symptoms and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy. The total score ranges from 0 to 100 points, with higher scores indicating greater disability. The outcome will be the mean change from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Baseline and 6 months after the second injection
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months
Tijdsspanne: Baseline and 6 months after the second injection
Symptoms and function associated with Achilles tendinopathy will be assessed using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The total score ranges from 0 to 100 points, with higher scores indicating better function and fewer symptoms. The outcome will be the mean change from baseline to 6 months after the second injection. An increase in score indicates improvement.
Baseline and 6 months after the second injection

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months
Tijdsspanne: Baseline and 1, 3, and 12 months after the second injection
Pain intensity will be measured using a 100-millimeter (mm) Visual Analog Scale (VAS), ranging from 0 mm, indicating no pain, to 100 mm, indicating the worst imaginable pain. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. A decrease in score indicates improvement.
Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 1, 3, and 12 Months
Tijdsspanne: Baseline and 1, 3, and 12 months after the second injection
Upper-limb symptoms and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy. The total score ranges from 0 to 100 points, with higher scores indicating greater disability. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. A decrease in score indicates improvement.
Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 1, 3, and 12 Months
Tijdsspanne: Baseline and 1, 3, and 12 months after the second injection
Symptoms and function associated with Achilles tendinopathy will be assessed using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The total score ranges from 0 to 100 points, with higher scores indicating better function and fewer symptoms. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. An increase in score indicates improvement.
Baseline and 1, 3, and 12 months after the second injection
Time From the Second Injection to Return to the Pre-Injury Level of Physical Activity
Tijdsspanne: From the second injection through 12 months of follow-up
The number of days from the second injection to the first documented return to the participant's pre-injury level of physical activity without activity restrictions will be recorded. Participants who do not return to their pre-injury activity level during follow-up will be considered not to have experienced the event by the end of the 12-month follow-up period.
From the second injection through 12 months of follow-up
Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects
Tijdsspanne: From the first injection through 12 months after the second injection
The number and percentage of participants experiencing one or more adverse events (AEs), serious adverse events (SAEs), or adverse device effects (ADEs) will be reported. Events will be assessed according to their type, severity, seriousness, and relationship to the administered intervention.
From the first injection through 12 months after the second injection

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ortonika Orthopedic Medical Clinic in Lublin

Onderzoekers

  • Hoofdonderzoeker: Tomasz Wnuk, MD, PhD, Ortonika Orthopedic Medical Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juni 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2026

Eerst geplaatst (Werkelijk)

20 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1.0 13.04.2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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