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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
时间窗: 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.
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 6 Months
时间窗: 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.
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months
时间窗: 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.
次要结局
- Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months(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(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(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(From the second injection through 12 months of follow-up)
- Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects(From the first injection through 12 months after the second injection)
研究者
Tomasz Wnuk, MD, PhD
Principal Investigator
Ortonika Orthopedic Medical Clinic in Lublin