Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Launched by CEDARS-SINAI MEDICAL CENTER · Feb 9, 2023

Keywords

ClinConnect Summary

The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals 18 years old or older are included
• • Patients with atraumatic lateral epicondylitis symptoms
• • Symptoms persistent and present for at least 2 weeks
• • Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.
• Exclusion Criteria:
• • Any records flagged "break the glass" or "research opt out."
• • Patients with elbow osteoarthritis,
• • Patients with a history of traumatic injury to the elbow
• • Patients with workers compensation
• • Patients who received cortisol injection in the elbow
• • MRI evidence of common extensor tear
• • A history of surgery on the affected elbow,
• • Cognitive or behavioral problems which would preclude informed consent.
• • Patients with coagulopathies
• • Patients who are pregnant
• • Patients who had a cortisone injection within 3 months