Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Measure of Pain Level: VISA-P Score
研究概览
简要总结
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
详细描述
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 39 years
- •Chronic (>3 months) PT
- •Clinical examination consistent with PT
- •MRI or US confirmation of PT
- •Pain score of 3 or greater on a 10-point visual analogue scale
- •Self-report failure of supervised physical therapy
- •Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).
排除标准
- •Inability to comply with study follow-up requirements
- •History of bleeding disorders or other hematologic conditions
- •Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
- •Full or partial patellar tendon tear
- •Current use of anticoagulation or immunosuppressive therapy
- •Prior knee trauma requiring medical attention or surgery
- •Worker's compensation injury
- •Daily opioid use for pain
- •Contraindication to MRI.
- •Systemic diseases such as Diabetes and connective tissue diseases.
- •Prior PRP or DN procedure.
- •Women that are pregnant
结局指标
主要结局
Change in Measure of Pain Level: VISA-P Score
时间窗: baseline, 16 weeks, 32 weeks, 52 weeks
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Change in Measure of Activity Level: Tegner Activity Level Score
时间窗: baseline, 16 weeks, 32 weeks, 52 weeks
The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
Change in Visual Analogue Scale (VAS) Pain Score
时间窗: baseline, 16 weeks, 32 weeks, 52 weeks
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
次要结局
- MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)(baseline, 16 weeks, 52 weeks)
- MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)(baseline, 16 weeks, 52 weeks)
- Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)(baseline, 16 weeks, 52 weeks)
- Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline(baseline, 16 weeks, 52 weeks)
- Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline(baseline, 16 weeks, 52 weeks)