Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Cedars-Sinai Medical Center66 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tennis Elbow

Interventions

Percussive Therapy DeviceDEVICE

Same as group description

Physical TherapyBEHAVIORAL

Same as group description

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Time to Improvement of Symptoms

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

PROMIS Physical Functioning

Patient-Reported Outcomes Measurement Information System Physical function 0-100 indicating overall functionality with higher scores representing more functionality

Time frame: 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

Time frame: 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

Time frame: 3 months

VAS pain score

Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10

Time frame: 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

Central Contacts

Joshua Langberg, B.A

CONTACT

8184423333 joshua.langberg@cshs.org

Data from ClinicalTrials.gov

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