Treatment of Lateral Epicondylitis With a Percussive Therapy Device

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05723809
• Collaborator: Therabody (Other)
• Enrollment: 66
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 10.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tennis Elbow	Device: Percussive Therapy Device; Behavioral: Physical Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to Improvement of Symptoms [3 months]

Secondary Outcome Measures

1. 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

2. PROMIS Physical Functioning [3 months]

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

3. 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

4. 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

5. VAS pain score [3 months]

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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center
• Therabody

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Stone, Principal Investigator, Assistant Professor, Orthopedic Surgeon, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT05723809
• Other Study ID Numbers: STUDY00002285
• First Posted: Feb 13, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Tennis Elbow

Study Results

No Results Posted as of Feb 13, 2023