Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Tennis Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05723809
• Other study ID #: STUDY00002285
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2023
• Source: Cedars-Sinai Medical Center
• Contact: Joshua Langberg, B.A
• Phone: 8184423333
• Email: joshua.langberg[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Device:
• Percussive Therapy Device
Same as group description

Behavioral:
• Physical Therapy
Same as group description

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Therabody

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Improvement of Symptoms		3 months
Secondary	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
Secondary	PROMIS Physical Functioning	Patient-Reported Outcomes Measurement Information System; Physical function 0-100 indicating overall functionality with higher scores representing more functionality	3 months
Secondary	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
Secondary	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
Secondary	VAS pain score	Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10	3 months
Secondary	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