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Completed

NCT Number: NCT06637241

Risk Stratification Care for Injury Prevention in Taiwan Adolescent Baseball Players

Due to frequent practices and competitions, Taiwanese adolescent baseball players gradually accumulate fatigue, leading to injuries in their throwing arms. Previous research on baseball has primarily focused on the epidemiology of sports injuries, biomechanical analysis of throwing motions, and the effectiveness of injury prevention interventions. Based on our previous research on the quality of life of Taiwanese adolescent baseball players, we have gained a general understanding of the impact of throwing arm injuries on these athletes. This study aims to stratify the injury risks of these baseball players based on past research and provide corresponding care guidelines according to different risk levels. We will compare this care model with standard care through a cluster randomized controlled trial, aiming to verify that this model is effective, efficient, and more clinically applicable than previous injury prevention interventions. Ultimately, we hope to promote this care model across all youth baseball teams in Taiwan.

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Key information

Age range

12 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

Baseball involves repetitive throwing motions that place considerable stress on the shoulder and elbow, leading to throwing arm injuries. Previous studies have shown that baseball players are at a higher risk of upper limb injuries compared to the general population, particularly pitchers. In Major League Baseball (MLB) in the United States, more than half of the injuries are to the upper limbs, and 48.4% of these are caused by throwing motions. Since throwing is a crucial part of baseball, injuries to the throwing arm can result in significant disability, both in sports and non-sports contexts. These disabilities not only affect the performance of baseball players but also have broader implications, including psychological and social impacts.

Recently, the importance of patient-reported outcomes (PRO) in clinical research has been increasingly recognized. In the past, clinical assessments focused primarily on physician evaluations of physical examinations and diagnostic test results. However, these measures may not accurately reflect patients' actual experiences. PROs can help physicians assess patients' health-related quality of life (HRQOL). This concept has also started to gain traction in the field of sports medicine.

Taiwanese adolescent baseball players face varying degrees of injury risk based on their defensive positions. In addition, measuring HRQOL may help identify injury risks that cannot be determined solely by their defensive positions. For high-risk baseball players, early referral to a physician for further examination and treatment can greatly aid in preventing injuries or facilitating recovery and return to the field after an injury. To identify high-risk individuals among a group of baseball players, our research team has collaborated with several junior high and high school baseball teams in Kaohsiung (including seven junior high schools and one high school).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All youths who are members of their school's baseball team and are willing to participate in the study with parental consent.
  • Agree to participate in the trial and complete the participant consent form.

Exclusion criteria

(1) A history of significant musculoskeletal or neurological injuries (or functional abnormalities).

Treatment and study plan

Risk stratification care

Behavioral

In this group, Taiwanese adolescent baseball players are categorized into high-risk, medium-risk, and low-risk groups based on injury risk from a previous study. High-risk players receive sports protection education and physician referrals for shoulder and elbow assessments, with further imaging if necessary. Common issues like Little League shoulder and elbow are managed with conservative treatments. The sports protection education includes the Modified Yokohama Baseball-9 (mYKB-9), a program that significantly reduces injuries with exercises targeting shoulder and elbow health. Medium-risk players receive mYKB-9 education only, while low-risk players are observed without changes to their training methods.

Primary outcomes

  1. Functional Arm Scale for Throwers (FAST)

    Time frame: From enrollment to the end of study at 12 months.

    This study strives to observe changes in the quality of life among Taiwanese adolescent baseball players over the course of a year. To achieve this, the questionnaire will be administered multiple times, with visits to the schools for measurements once per season (every 3 months). The primary measurement tool will be the Chinese version of the FAST scale, which has been validated in preliminary research.

Secondary outcomes

  1. Injury

    Time frame: From enrollment to the end of the study at 12 months

    Each season, during school visits, the study will examine baseball players in the team who have experienced throwing arm injuries. Coaches will be asked to identify players who have had injuries in the past three months and refer them to the visiting physician for assessment. If physical examination and ultrasound screening confirm abnormalities in the shoulder (such as rotator cuff tendinitis or tears, shoulder labral injuries, etc.) or elbow (such as medial epicondylitis, ulnar collateral ligament injuries, osteochondritis dissecans, etc.), the player will be classified as injured. Injury data will be categorized as follows: injury occurrence (dichotomous data), number of injuries (count data), and severity (ordinal data). The number of injuries will be determined by asking players how many times they have experienced throwing arm injuries in the past three months.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Compare the Effectiveness of Injury Prevention Between Risk Stratification Care and Usual Care in Taiwan Adolescent Baseball Players: a Cluster Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.