Ultrasound Study of Season-Long Joint Changes to College Baseball Players

August 4, 2015 updated by: Johnathan Anthony Erb, California State University, Northridge
The purpose of this study is to use ultrasound imaging to determine if there are certain frequencies, durations, and intensities of baseball pitching that expose a college baseball player to increased risk of injury to their ulnar collateral ligament of their elbow throughout one baseball season.

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to use ultrasound imaging to assess the health of the ulnar collateral ligament (UCL) of the elbow, which acts as a major stabilizer in overhead throwing athletes and is often injured in baseball pitchers. The health of the UCL will be assessed by measured the amount of laxity in the UCL, identified as the distance between the end of the humerus (arm bone) where the UCL originates and the beginning of the ulna (forearm bone) where the UCL ends. An increase in this distance indicates an increase in laxity of the ligament, which is a risk factor for injury/tearing of the ligament with repetitive throwing seen in baseball pitchers. Measurements will be made at rest and under 3 pounds of valgus stress at 30 degrees of elbow flexion where the UCL acts as the main stabilizer of the elbow. Valgus stress is necessary for this procedure because damage to the ligament will be most clearly seen in this position when compared to the measurement at rest.

Measurements will be made to both the right and left elbows, as well as both the right and left knees. The purpose of including the knees in this protocol is so that the subjects are blinded to the true intention of the study. Due to the psychological harm that could occur if the subjects know the focus of the study is their UCL, the study will be presented to the subjects such that the research team is viewing all structures within the elbow and knee, and their overall flexibility, strength, and bony changes will be monitored throughout the season using ultrasound. Therefore, the ultrasound measurements of the knee will be sham measurements, and only measurements made at the elbow will be recorded.

In addition to ultrasound, measurements of range of motion will be performed at each testing session. Motions to be tested will be: shoulder flexion, extension, abduction, internal rotation, and external rotation; elbow flexion and extension; wrist flexion and extension; hip flexion, extension, abduction, internal rotation, and external rotation; knee flexion and extension. Recent studies have found significant results for deficits in range of motion correlating to UCL tears, so this data will be used in conjunction with measurements of laxity of the UCL as seen with ultrasound.

Ultrasound imaging and range of motion testing will be performed on the same 10 subjects four times throughout one baseball season: before the first game of the season, after 20 games have been played, after 40 games have been played, and after the last game of the season has been played. During this period, pitching data will be collected and recorded for each pitcher. Data to be collected includes number of pitches thrown, number of each type of pitch thrown, number of innings pitched, velocity of all pitches, time in days between pitching appearances.

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Members of the CSU Northridge baseball team

Description

Inclusion Criteria:

  • Must be a member of the CSU Northridge baseball team
  • Able to provide written, informed consent
  • Understand instruction in English
  • Be between the age of 18 and 24 years

Exclusion Criteria:

  • Is not a member of the CSU Northridge baseball team
  • Experience pain or injury during testing procedures of the research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Baseball players
Members of the baseball team, both pitchers and fielders, who participate in repetitive baseball throwing and are exposed to damage of the ulnar collateral ligament in the arm that is used for throwing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint distance
Time Frame: 18 weeks
Allows for a measurement of distance, in millimeters, of the UCL from the humerus to the ulna to be made using ultrasound imaging.
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goniometry
Time Frame: 18 weeks
Measures the available amount of motion, in degrees, at multiple joints.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State University, Northridge

Investigators

  • Principal Investigator: Johnathan A Erb, CSU Northridge
  • Study Director: Aimie Kachingwe, CSU Northridge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1415-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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