Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
| Registry | NCT05723809 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 66 (Estimated) |
| Sponsor | Cedars-Sinai Medical Center (Other); collaborators: Therabody, Inc. |
| Conditions | Tennis Elbow |
| Interventions | Percussive Therapy Device, Physical Therapy (Device, behavioral) |
| Dates | start 2023-03-01 (estimated), primary completion 2023-09-01 (estimated), completion 2023-09-01 (estimated), first posted 2023-02-13, last updated 2023-02-13 |
| Locations | 1 site in United States |
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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
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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Percussive Therapy Device | Experimental | Device: Percussive Therapy Device; Behavioral: Physical Therapy | 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 |
| Control group | Active comparator | Behavioral: Physical Therapy | Participants will be going to physical therapy - 1 session per week for 6 weeks |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles, California | United States |