Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tomasz Wnuk, MD, PhD
- 电话号码：+48 538 360 332
- 邮箱：tomashorto@gmail.com
学习地点
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Lublin Voivodeship
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Lublin、Lublin Voivodeship、波兰、20-841
- 招聘中
- Ortonika Orthopedic Medical Clinic in Lublin
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接触：
- Tomasz Wnuk, MD, PhD
- 电话号码：+48 538 360 332
- 邮箱：tomashorto@gmail.com
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首席研究员：
- Tomasz Wnuk, MD, PhD
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副研究员：
- Piotr Przybylski, MD, PhD
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副研究员：
- Mateusz Matyjaszczyk, MD
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副研究员：
- Przemysław Golonka, MD
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副研究员：
- Damian Borys, MD
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副研究员：
- Beata Krupska, MSc
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副研究员：
- Emilia Antoniewska, MSc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
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Assigned to: Arm 1
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实验性的：Arm 2 - Platelet-Rich Plasma (PRP)
Two peritendinous or intratendinous injections of autologous platelet-rich plasma (PRP), administered two weeks apart under ultrasonographic guidance.
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Assigned to: Arm 2
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
大体时间：Baseline and 6 months after the second injection
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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.
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Baseline and 6 months after the second injection
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Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 6 Months
大体时间：Baseline and 6 months after the second injection
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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.
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Baseline and 6 months after the second injection
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Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months
大体时间：Baseline and 6 months after the second injection
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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.
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Baseline and 6 months after the second injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months
大体时间：Baseline and 1, 3, and 12 months after the second injection
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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.
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Baseline and 1, 3, and 12 months after the second injection
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Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 1, 3, and 12 Months
大体时间：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.
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Baseline and 1, 3, and 12 months after the second injection
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Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 1, 3, and 12 Months
大体时间：Baseline and 1, 3, and 12 months after the second injection
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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.
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Baseline and 1, 3, and 12 months after the second injection
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Time From the Second Injection to Return to the Pre-Injury Level of Physical Activity
大体时间：From the second injection through 12 months of follow-up
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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.
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From the second injection through 12 months of follow-up
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Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects
大体时间：From the first injection through 12 months after the second injection
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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.
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From the first injection through 12 months after the second injection
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合作者和调查者
调查人员
- 首席研究员：Tomasz Wnuk, MD, PhD、Ortonika Orthopedic Medical Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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