Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies (RWE-TDP-PRP)
Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Resport Clinic, MD PhD
- 電話番号：+34 93 2778709
- メール：abat@resportclinic.com
研究場所
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A Coruña、スペイン、15009
- 募集
- Instituto Médico Arriaza
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コンタクト：
- Dr Rafael Arriaza, MD
- 電話番号：+34 981 113 030
- メール：info@arriaza.es
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Barcelona、スペイン、08023
- 募集
- Instituto Cugat
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コンタクト：
- Dr Ramón Cugat, MD PhD
- 電話番号：+34 938 34 64 50
- メール：info@institutocugat.com
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Barcelona、スペイン、08029
- 募集
- ReSport Clinic
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コンタクト：
- Dr Ferran Abat, MD PhD
- 電話番号：+34 932 77 87 09
- メール：abat@resportclinic.com
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Madrid、スペイン、28010
- 募集
- Ripoll y dePrado Medical Group
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コンタクト：
- Dra Patricia Núñez, MD
- 電話番号：+34 91 457 78 02
- メール：madrid@ripollydeprado.com
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Vitoria-Gasteiz、スペイン、01010
- 募集
- Hospital MIKS
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コンタクト：
- Dr Mikel Sanchez, MD PhD
- メール：pacientes@hospitalmiks.com
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Clinical and/or ultrasound diagnosis of chronic tendinopathy (duration >6 weeks)
- Age >18 years
- Provision of written informed consent
- Willingness and ability to complete follow-up assessments for 12 months
Exclusion Criteria:
- Surgical treatment of the affected tendon within the previous 6 months
- Corticosteroid injection within the last month
- Systemic inflammatory disease (e.g., rheumatoid arthritis)
- Coagulopathies or ongoing anticoagulant therapy
- Complete blood count showing a platelet concentration <100 × 10⁹/L (to exclude patients with potential thrombocytopenia)
- Pregnancy or breastfeeding
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Patellar tendinopathy
Patellar tendinopathy treated with PRP
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A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions |
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Achilles tendinopathy
Achilles tendinopathy treated with PRP
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A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions |
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Plantar fasciosis
Plantar fasciosis treated with PRP
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A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions |
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Chronic epycondylitis
Chronic epycondylitis treated with PRP
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A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions |
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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Visual Analog Scale
時間枠：From baseline up to 12 months post-treatment
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From baseline up to 12 months post-treatment
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VISA-P
時間枠：baseline, 1 month, 3 months, 6 months and 12 months
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Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire.
Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.
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baseline, 1 month, 3 months, 6 months and 12 months
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VISA-A
時間枠：baseline, 1 month, 3 months, 6 months and 12 months
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The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
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baseline, 1 month, 3 months, 6 months and 12 months
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Patient Rated Tennis Elbow Evaluation Scale
時間枠：baseline, 1 month, 3 months, 6 months and 12 months
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The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item self-report questionnaire designed to measure pain and functional disability in patients with lateral epicondylitis (tennis elbow).
It includes a 5-item pain subscale and a 10-item function subscale, providing a total score out of 100 to assess, evaluate, and monitor recovery.
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baseline, 1 month, 3 months, 6 months and 12 months
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Foot Function Index
時間枠：baseline, 1 month, 3 months, 6 months and 12 months
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The Foot Function Index (FFI) is a 23-item, self-administered questionnaire designed to measure the impact of foot pathology on function, assessing pain, disability, and activity limitation.
It uses a 0-10 Likert scale for items within three subscales, with higher total percentages (0-100%) indicating greater, more severe pain and dysfunction.
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baseline, 1 month, 3 months, 6 months and 12 months
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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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Predictive factors of response to PRP treatment
時間枠：baseline
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Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
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baseline
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Adverse events
時間枠：1 month, 3 months, 6 months, 12 months
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Assess the incidence of local or systemic adverse events following PRP administration
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1 month, 3 months, 6 months, 12 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
その他の研究ID番号
- RWE-TDP-20251206
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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