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Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers

Primary Purpose

Elbow Injuries, Sprain Ulnar Collateral Ligament, Upper Extremity Injuries

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strengthening program
Exercise program
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Elbow Injuries focused on measuring Ulnar collateral ligament, elbow injuries, dynamic elbow stabilizers, Tommy John's procedure, elbow injuries in pitchers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pitchers that are currently on a minor league baseball team.

Exclusion Criteria:

  • Pitchers that currently have upper extremity injuries or are in active rehab for upper extremity injury.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minor league pitchers

Arm Description

Minor league pitchers from a single professional baseball organization. Strength tests of the elbows will be administered at spring training and end of season for 5 years. If strength correlates to injury, strengthening and exercise programs may be established to target the stabilizers of the elbows.

Outcomes

Primary Outcome Measures

The Correlation of Strength to UCL Injuries in Minor League Pitchers
After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.

Secondary Outcome Measures

The Diminution of Strength in Minor League Pitchers
We will measure the diminution of strength over the course of a baseball season.

Full Information

First Posted
April 11, 2016
Last Updated
October 31, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02749760
Brief Title
Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers
Official Title
The Effect of Dynamic Stabilizers for Valgus Stability of the Elbow in Professional Baseball Players
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis (FDS), and wrist flexion strength will be measured and correlated with upper extremity injuries and time missed from pitching. The investigators will also be measuring loss of strength over the season. The goal is to learn whether strength in these muscles prevents UCL injuries and finally whether these muscles can be strengthened to avoid such injuries.
Detailed Description
The goal of this study is to assess whether the strengths of the secondary muscular stabilizers toward valgus stress at the elbow, the wrist flexors, flexor digitorum superficialis, and pronator teres emanating from the medial epicondyle, affect the incidence of ulnar collateral ligament injuries of the elbows in pitchers. Pitchers in the minor leagues of a single professional baseball club will have the strength of these secondary muscular stabilizers assessed and then correlated to ulnar collateral ligament injuries and time missed from baseball season and subsequent seasons. A secondary goal is to assess whether strengthening exercises targeted toward these muscular stabilizers of the elbow can decrease the incidence of ulnar collateral ligament injuries in young baseball pitchers. This could impact the field by changing the emphasis from reconstruction and rehabilitation of ulnar collateral ligament injuries to prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Injuries, Sprain Ulnar Collateral Ligament, Upper Extremity Injuries, Strain of Ulnar Collateral Ligament, Complete Tear Ulnar Collateral Ligament
Keywords
Ulnar collateral ligament, elbow injuries, dynamic elbow stabilizers, Tommy John's procedure, elbow injuries in pitchers

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minor league pitchers
Arm Type
Other
Arm Description
Minor league pitchers from a single professional baseball organization. Strength tests of the elbows will be administered at spring training and end of season for 5 years. If strength correlates to injury, strengthening and exercise programs may be established to target the stabilizers of the elbows.
Intervention Type
Other
Intervention Name(s)
Strengthening program
Intervention Description
Strengthening programs may be established to target the stabilizers of the elbows
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Exercise program may be established to target the stabilizers of the elbows.
Primary Outcome Measure Information:
Title
The Correlation of Strength to UCL Injuries in Minor League Pitchers
Description
After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The Diminution of Strength in Minor League Pitchers
Description
We will measure the diminution of strength over the course of a baseball season.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pitchers that are currently on a minor league baseball team. Exclusion Criteria: Pitchers that currently have upper extremity injuries or are in active rehab for upper extremity injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E B Toby, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers

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