PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis

Completed · Phase 2

Conditions studied: Chronic Lateral Epicondylosis

In brief

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.

Key facts

Study ID

NCT03072381

Run by

University of Wisconsin, Madison

People needed

50

Starts

2017-01-01

Expected to finish

2020-10-28

Last updated by the study team

2020-12-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18-65
• chronic (>3months) unilateral or bilateral common extensor tendon pain
• clinical exam findings consistent with CLE
• imaging confirmation of CLE (U/S or MRI)
• self-reported failure of supervised physical therapy; 6) self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for CLE.

You may not qualify if…

• inability to comply with follow-up requirements of study
• history of bleeding disorders, low-platelet counts, other hematologic conditions
• elbow pain with other possible etiologies (e.g., degenerative joint disease)
• currently using anticoagulation or immunosuppressive therapy
• anticoagulant or immunosuppressive therapy within the prior month
• known allergy to Lidocaine
• self-reported pregnancy
• worker's compensation injury
• pending litigation
• concurrent opioid use for pain
• corticosteroid injection within the past 3 months
• minors

Where it is running

• Wisconsin Institute of Medical Research (WIMR) — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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