Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Cedars-Sinai Medical Center

Status: Not yet enrolling

Conditions: Tennis Elbow

Treatments: Behavioral: Physical Therapy; Device: Percussive Therapy Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05723809

STUDY00002285

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow

Full description

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)

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Percussive Therapy Device

Experimental group

Description:

Participants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes

Treatment:

Device: Percussive Therapy Device

Behavioral: Physical Therapy

Control group

Active Comparator group

Description:

Participants will be going to physical therapy - 1 session per week for 6 weeks

Treatment:

Behavioral: Physical Therapy