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OpenTrials
Completed

NCT Number: NCT06904430

Buckets vs. Braces Prospective Study

The purpose of this research study is to determine if there is a difference in shoulder or elbow pain between youth athletes who throw regularly without a brace, those who use a brace, and those who limit their throw count by placing the ball in a bucket during a 12-week study.

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Key information

Conditions

Elbow Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Orange County

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or females aged 8- 12 years old
  • Participation and attendance on at least 80% of practices league team
  • Only participating on one baseball team for the next 12 weeks

Exclusion criteria

  • Patients <8 or >12 years of age
  • Elbow pain at the start of the season
  • History of an elbow or shoulder injury, past surgeries
  • Participants currently under the care of a physician for an elbow or shoulder issue
  • Participants taking outside private coaching

Treatment and study plan

Bucket Group

Other

This Bucket Intervention is behavioral and studies the effect of players limiting their throw count during practice to reduce pain occurrence

Brace Group

Device

The Brace intervention studies the use of players using an elbow throwing brace during practice to reduce the occurrence of pain

Primary outcomes

  1. To determine if there is a difference in shoulder or elbow pain between youth athletes that threw regularly without a brace, those that used a brace and those that limited their throw count by placing the ball in a bucket during a six-week study.

    Time frame: 12 weeks

    Shoulder and Elbow pain were assessed using the Kerlan-Jobe Orthopedic Clinic (KJOC) Shoulder and Elbow Score questionnaire. These questions are scored from 1-10 with 10 being the highest/better outcome.

Secondary outcomes

  1. To identify quality of life/patient and family satisfaction with the use of limiting throw count

    Time frame: 12 weeks

    Participants and Families filled outcome questionnaires at baseline, midpoints, and endpoint of study responding to their satisfaction of the study and group assignments using yes/no questions, with 'yes' being the better outcome.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Orange County

Other

Registry information

Official study title

Buckets vs Braces: Is Throw Count a Preventative Measure for Injury in Youth Throwers?

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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