drugset / Trial / NCT03072381

PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis

NCT03072381

RandomizedParallel-groupDouble-blindTreatment

Summary

The proposed project will be the first to assess pain- and function-dependent, elbow-specific quality of life and in-vivo mechanical properties of common extensor tendons post-treatment with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will significantly add to the knowledge base of treatment effects of PRP for a chronic tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with validated clinical outcomes will provide a powerful tool for future outcomes analyses using a non-invasive imaging modality to monitor tissue healing both morphologically as well as biomechanically, and may even be used to evaluate injury risk.

Timeline

Start
2017-01
Primary completion
2020-10-28
Completion
2020-10-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Platelet Rich Plasma Other / unclassified 3 ml Other
Comparator Triamcinolone Hexacetonide Other / unclassified 40 mg Other
Comparator Lidocaine Other / unclassified 2 ml Other

Indications