Treatment of Lateral Epicondylitis With a Percussive Therapy Device

NCT ID: NCT05723809

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-09-01

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)

Conditions

Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Percussive Therapy Device

Intervention Type: DEVICE

Same as group description

Physical Therapy

Intervention Type: BEHAVIORAL

Same as group description

Control group

Participants will be going to physical therapy - 1 session per week for 6 weeks

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: BEHAVIORAL

Same as group description

Interventions

Percussive Therapy Device

Same as group description

Intervention Type: DEVICE

Physical Therapy

Same as group description

Intervention Type: BEHAVIORAL

Other Intervention Names

Theragun

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therabody, Inc.

INDUSTRY

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Stone

Principal Investigator, Assistant Professor, Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Stone, M.D

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Joshua Langberg, B.A

Role: CONTACT

joshua.langberg@cshs.org

8184423333

Facility Contacts

Michael A Stone, M.D

Role: primary

310-423-4566

Other Identifiers

STUDY00002285

Identifier Type: -

Identifier Source: org_study_id