Chronic Patellar Tendinopathy Clinical Trial
— PRPOfficial title:
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
Verified date | April 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | February 29, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. age18-65 2. chronic (>3months) patellar tendon pain; 3. clinical exam findings consistent with PT; 4. self-reported failure of supervised physical therapy; 5. self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for patellar tendinopathy. Exclusion Criteria: 1. inability to comply with follow-up requirements of study, 2. history of bleeding disorders, low-platelet counts, other hematologic conditions; 3. knee pain due to another possible etiology(e.g., degenerative joint disease); 4. current or recent use of anticoagulation or immunosuppressive therapy; 5. known allergy to acetaminophen or Lidocaine; 6. self-reported pregnancy; 7. worker's compensation injury; 8. pending litigation; 9. concurrent opioid use for pain |
Country | Name | City | State |
---|---|---|---|
United States | UW Sports Medicine Clinic at Research Park | Madison | Wisconsin |
United States | Wisconsin Institute of Medical Research | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Knee Injection Survey: PRP Satisfaction Questionnaire | Outcome measures will be compared for satisfaction with PRP therapy as assessed by the treatment satisfaction survey score at 32 weeks post-treatment. This survey is a 5-item survey that assesses severity of symptoms (0 no symptoms to 6 worst symptoms) level of difficulty in using the knee, if any, (1 mild to 4 unable to use knee) change in knee symptoms since treatment (-3 very much worse to 0 no change to 3 very much improved) physical ease, comfort, convenience, and effectiveness satisfaction with PRP therapy (each from -3 extremely dissatisfied to 0 neutral to 3 extremely satisfied), and temporary pain, bruising, swelling, bleeding, or other side effects (from 5 all of the time to 0 none of the time) |
up to 32 weeks | |
Primary | Change in Victorian Institute of Sport Assessment-Patellar (VISAP) Score | 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 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. | 0, 4, 8, 12, 16, and 32 weeks | |
Primary | Change in International Knee Documentation Committee (IKDC) Score | 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 International Knee Documentation Committee (IKDC). The total possible range of scores is 0-100 with higher scores indicating increased discomfort and interference with daily activities. | 0, 4, 8, 12, 16, and 32 weeks | |
Primary | Change in Knee Injection Questionnaire Score | 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. | 0, 4, 8, 12, 16, and 32 weeks | |
Secondary | Change in Thickness of Patellar Tendon Compared to Contralateral | Ultrasound (US) changes of several pathologic features of PT will be evaluated using US imaging of the patellar tendon at 32 weeks compared to baseline imaging. Conventional ultrasound will be done to assess patellar tendon thickness (contralateral comparison). | baseline to 32 weeks | |
Secondary | Change in Neovascularity of Patellar Tendon | Ultrasound (US) changes of several pathologic features of PT will be evaluated using US imaging of the patellar tendon at 32 weeks compared to baseline imaging. Conventional ultrasound will be done to assess patellar tendon neovascularity. | baseline to 32 weeks | |
Secondary | Change in Hypoechogenicity of Patellar Tendon | Ultrasound (US) changes of several pathologic features of PT will be evaluated using US imaging of the patellar tendon at 32 weeks compared to baseline imaging. Conventional ultrasound will be done to assess patellar hypoechogenicity. | baseline to 32 weeks | |
Secondary | Change in Stiffness of Patellar Tendon | Acoustoelastography (AE) will be done to measure stiffness changes of the patellar tendon using standardized 0-3 severity scales compared to control subjects. | baseline to 32 weeks |