Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Not Applicable

Not yet recruiting

• Conditions: Tennis Elbow
• Interventions: Device: Percussive Therapy Device; Behavioral: Physical Therapy

• Registration Number: NCT05723809
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-30
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13
• Study Start: 2023-03-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percussive Therapy Device	Percussive Therapy Device	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
Percussive Therapy Device	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	Physical Therapy	Participants will be going to physical therapy - 1 session per week for 6 weeks

Primary Outcome Measures

Name	Time	Method
Time to Improvement of Symptoms	3 months

Secondary Outcome Measures

Name	Time	Method
PROMIS Upper Extremity	3 months	Patient-Reported Outcomes Measurement Information System; Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality
PROMIS Physical Functioning	3 months	Patient-Reported Outcomes Measurement Information System; Physical function 0-100 indicating overall functionality with higher scores representing more functionality
PROMIS Pain Interference	3 months	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
SANE score	3 months	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
PROMIS Depression	3 months	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
VAS pain score	3 months	Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States