Clincosm LogoSign in Get a demo

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

Sponsor
California State University, Northridge (Other)
Overall Status
Completed
CT.gov ID
NCT02343640
Collaborator
(none)
10
Enrollment
3.9
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ultrasound Study of Season-Long Joint Changes to College Baseball Players
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    May 1, 2015
    Actual Study Completion Date :
    May 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Joint distance [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.

    Secondary Outcome Measures

    1. Goniometry [18 weeks]

      Measures the available amount of motion, in degrees, at multiple joints.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 24 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • California State University, Northridge

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johnathan Anthony Erb, Student, California State University, Northridge
    ClinicalTrials.gov Identifier:
    NCT02343640
    Other Study ID Numbers:
    • 1415-093
    First Posted:
    Jan 22, 2015
    Last Update Posted:
    Aug 6, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Johnathan Anthony Erb, Student, California State University, Northridge
    Baseball
    Ulnar collateral ligament

    Study Results

    No Results Posted as of Aug 6, 2015