Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial

Conditions
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Tennis Elbow

Intervention / Treatment
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* Device: Percussive Therapy Device
* Behavioral: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percussive Therapy Device<br>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 | Device: Percussive Therapy Device<br>* Same as group description<br>* Other names: Theragun;Behavioral: Physical Therapy<br>* Same as group description<br>|
| Active Comparator: Control group<br>Participants will be going to physical therapy - 1 session per week for 6 weeks | Behavioral: Physical Therapy<br>* Same as group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Improvement of Symptoms |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Upper Extremity | Patient-Reported Outcomes Measurement Information System Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality | 3 months | 
| PROMIS Physical Functioning | Patient-Reported Outcomes Measurement Information System Physical function 0-100 indicating overall functionality with higher scores representing more functionality | 3 months | 
| PROMIS Pain Interference | Patient-Reported Outcomes Measurement Information System Pain interference 0-100 measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities with higher scores representing more interference | 3 months | 
| PROMIS Depression | Patient-Reported Outcomes Measurement Information System Depression - 0-100 assess self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose) with higher scores indicating more depression | 3 months | 
| VAS pain score | Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10 | 3 months | 
| SANE score | Single Assessment Numeric Evaluation - This is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100 | 3 months |