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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tomasz Wnuk, MD, PhD
- 電話番号：+48 538 360 332
- メール：tomashorto@gmail.com
研究場所
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Lublin Voivodeship
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Lublin、Lublin Voivodeship、ポーランド、20-841
- 募集
- Ortonika Orthopedic Medical Clinic in Lublin
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コンタクト：
- Tomasz Wnuk, MD, PhD
- 電話番号：+48 538 360 332
- メール：tomashorto@gmail.com
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主任研究者：
- Tomasz Wnuk, MD, PhD
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副調査官：
- Piotr Przybylski, MD, PhD
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副調査官：
- Mateusz Matyjaszczyk, MD
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副調査官：
- Przemysław Golonka, MD
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副調査官：
- Damian Borys, MD
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副調査官：
- Beata Krupska, MSc
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副調査官：
- Emilia Antoniewska, MSc
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Tomasz Wnuk, MD, PhD、Ortonika Orthopedic Medical Clinic
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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