Treatment of Lateral Epicondylitis With a Percussive Therapy Device

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tennis Elbow
• Intervention / Treatment: Device: Percussive Therapy Device; Behavioral: Physical Therapy

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Langberg, B.A; Phone Number: 8184423333; Email: joshua.langberg@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
      • Contact: Michael A Stone, M.D; Phone Number: 310-423-4566

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: Percussive Therapy Device; Same as group description; Other Names: Theragun; Behavioral: Physical Therapy; Same as group description
ACTIVE_COMPARATOR: Control group; Participants will be going to physical therapy - 1 session per week for 6 weeks	Behavioral: Physical Therapy; Same as group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Therabody
• Investigators: Principal Investigator: Michael A Stone, M.D, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: STUDY00002285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes