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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Hyaluronic acid injection
  Assigned to: Arm 1
• Устройство Autologous Platelet-Rich Plasma Injection
  Assigned to: Arm 2

Первичные конечные точки

• Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months [Срок оценки: 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 [Срок оценки: Baseline and 6 months after the second injection]
• Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months [Срок оценки: Baseline and 6 months after the second injection]

Вторичные конечные точки (5)

• Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the second injection through 12 months of follow-up]
• Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects [Срок оценки: From the first injection through 12 months after the second injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Ortonika Orthopedic Medical Clinic in Lublin — Lublin

Идентификаторы

NCT: NCT07714811 · 1.0 13.04.2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗