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

14 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Tomasz Wnuk, MD, PhD
  • Número de teléfono: +48 538 360 332
  • Correo electrónico: tomashorto@gmail.com

Ubicaciones de estudio

  • Polonia
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polonia, 20-841
        • Reclutamiento
        • Ortonika Orthopedic Medical Clinic in Lublin
        • Contacto:
          • Tomasz Wnuk, MD, PhD
          • Número de teléfono: +48 538 360 332
          • Correo electrónico: tomashorto@gmail.com
        • Investigador principal:
          • Tomasz Wnuk, MD, PhD
        • Sub-Investigador:
          • Piotr Przybylski, MD, PhD
        • Sub-Investigador:
          • Mateusz Matyjaszczyk, MD
        • Sub-Investigador:
          • Przemysław Golonka, MD
        • Sub-Investigador:
          • Damian Borys, MD
        • Sub-Investigador:
          • Beata Krupska, MSc
        • Sub-Investigador:
          • Emilia Antoniewska, MSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Dispositivo: Hyaluronic acid injection
Assigned to: Arm 1
Experimental: Arm 2 - Platelet-Rich Plasma (PRP)
Two peritendinous or intratendinous injections of autologous platelet-rich plasma (PRP), administered two weeks apart under ultrasonographic guidance.
Dispositivo: Autologous Platelet-Rich Plasma Injection
Assigned to: Arm 2

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ortonika Orthopedic Medical Clinic in Lublin

Investigadores

  • Investigador principal: Tomasz Wnuk, MD, PhD, Ortonika Orthopedic Medical Clinic

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

3 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de julio de 2026

Publicado por primera vez (Actual)

20 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1.0 13.04.2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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