PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis

• Status: Completed
• Trial end date: 2020-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: DePuy Synthes
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. age 18-65

2. chronic (>3months) unilateral or bilateral common extensor tendon pain

3. clinical exam findings consistent with CLE

4. imaging confirmation of CLE (U/S or MRI)

5. 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.

Exclusion Criteria:

1. inability to comply with follow-up requirements of study

2. history of bleeding disorders, low-platelet counts, other hematologic conditions

3. elbow pain with other possible etiologies (e.g., degenerative joint disease)

4. currently using anticoagulation or immunosuppressive therapy

5. anticoagulant or immunosuppressive therapy within the prior month

6. known allergy to Lidocaine

7. self-reported pregnancy

8. worker's compensation injury

9. pending litigation

10. concurrent opioid use for pain

11. corticosteroid injection within the past 3 months

12. minors