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Treatment of Lateral Epicondylitis With a Percussive Therapy Device

Primary Purpose

Tennis Elbow

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percussive Therapy Device
Physical Therapy
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Percussive Therapy Device

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to Improvement of Symptoms

Secondary Outcome Measures

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
PROMIS Physical Functioning
Patient-Reported Outcomes Measurement Information System Physical function 0-100 indicating overall functionality with higher scores representing more functionality
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
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
VAS pain score
Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10
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

Full Information

First Posted
January 30, 2023
Last Updated
February 9, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
Therabody
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1. Study Identification

Unique Protocol Identification Number
NCT05723809
Brief Title
Treatment of Lateral Epicondylitis With a Percussive Therapy Device
Official Title
Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Therabody

4. Oversight

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

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percussive Therapy Device
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will be going to physical therapy - 1 session per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
Percussive Therapy Device
Other Intervention Name(s)
Theragun
Intervention Description
Same as group description
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy
Intervention Description
Same as group description
Primary Outcome Measure Information:
Title
Time to Improvement of Symptoms
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PROMIS Upper Extremity
Description
Patient-Reported Outcomes Measurement Information System Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality
Time Frame
3 months
Title
PROMIS Physical Functioning
Description
Patient-Reported Outcomes Measurement Information System Physical function 0-100 indicating overall functionality with higher scores representing more functionality
Time Frame
3 months
Title
PROMIS Pain Interference
Description
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
Time Frame
3 months
Title
PROMIS Depression
Description
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
Time Frame
3 months
Title
VAS pain score
Description
Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10
Time Frame
3 months
Title
SANE score
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Langberg, B.A
Phone
8184423333
Email
joshua.langberg@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Stone, M.D
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael A Stone, M.D
Phone
310-423-4566

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Lateral Epicondylitis With a Percussive Therapy Device

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