The Clinical, Biomechanical, and Tissue Regenerating Effects of a Single Platelet-rich Plasma Injection for the Treatment of Chronic Patellar Tendinopathy: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Victorian Institute of Sport Assessment-Patellar (VISAP) Score
研究概览
简要总结
The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of PT.
详细描述
This study is a randomized, single-blinded controlled trial. Subjects, aged 18-65 with chronic patellar tendinopathy (PT), will be recruited through the University of Wisconsin (UW) Sports Medicine Clinics and the UW Physical Therapy Clinics. 44 subjects will be randomized to one of two study arms (22 in each group). Subjects and assessors will be blinded to the subject group allocation.
Subjects in Group 1 (PRP) will receive a single US-guided injection of up to 5 mL autologous platelet-rich plasma at week 0 (baseline). Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0. Subjects in both groups will receive just one session of injection.
Subjects invited to participate in the study will be asked to undergo a knee evaluation examination. Tender areas associated with the patellar tendon will be identified. This exam will occur at the US Sports Medicine Clinic at Research Park. If patient is being seen by PI for a routine clinic visit for knee pain, patient may be identified as a potential research participant. During the clinic visit, the patient will undergo a knee evaluation examination. If patient is confirmed to have patellar tendinopathy, the PI will introduce the study. If interested, the PI will conduct a brief in-person interview to determine eligibility via self-reported inclusion and exclusion criteria. Subjects who qualify will have written consent obtained prior to their knee exam.
Subjects will then report to WIMR where the ultrasound-guided procedures and follow-up diagnostic imaging will be conducted. The study coordinator will greet the subjects, remind them of the details of the study procedure, its potential benefits and risks, and answer questions. Dr. Lee will then meet the subject, answer any questions and assess vital signs.
The RN will prepare a 3 mL syringe of 1% lidocaine with a 30G, ½" long needle for pre-injection topical analgesia (skin wheal).
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
- Single (Participant)
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
- 是
入选标准
- •chronic (>3months) patellar tendon pain;
- •clinical exam findings consistent with PT;
- •self-reported failure of supervised physical therapy;
- •self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for patellar tendinopathy.
排除标准
- •inability to comply with follow-up requirements of study,
- •history of bleeding disorders, low-platelet counts, other hematologic conditions;
- •knee pain due to another possible etiology(e.g., degenerative joint disease);
- •current or recent use of anticoagulation or immunosuppressive therapy;
- •known allergy to acetaminophen or Lidocaine;
- •self-reported pregnancy;
- •worker's compensation injury;
- •pending litigation;
- •concurrent opioid use for pain
研究组 & 干预措施
Group 2
Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0.
干预措施: saline (Other)
Platelet Rich Plasma
Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous platelet-rich plasma at week 0 (baseline).
干预措施: platelet rich plasma (Biological)
结局指标
主要结局
Victorian Institute of Sport Assessment-Patellar (VISAP) Score
时间窗: baseline and 32 weeks
Participants will complete outcome questionnaires at baseline and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the validated Victorian Institute of Sport Assessment-Patellar (VISAP). The total possible range of scores is 0-100 with higher scores indicating fewer symptoms and higher function.
International Knee Documentation Committee (IKDC) Score
时间窗: baseline and 32 weeks
Participants will complete outcome questionnaires at baseline and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the International Knee Documentation Committee (IKDC). The total possible range of scores is 0-100 with higher scores indicating higher function and lower symptoms.
Knee Injection Questionnaire Score
时间窗: 0, 4, 8, 12, 16, and 32 weeks
Participants will complete outcome questionnaires at weeks 0, 4, 8, 12, 16, and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the Knee Injection Questionnaire. The total possible range of scores is 0-100 with higher scores indicating improved well being and ability to activities.
次要结局
- Thickness of Patellar Tendon Compared to Contralateral(baseline to 32 weeks)
- Neovascularity of Patellar Tendon(baseline to 32 weeks)
- Hypoechogenicity of Patellar Tendon(baseline to 32 weeks)
- Stiffness of Patellar Tendon(baseline to 32 weeks)