Buckets Vs. Braces Prospective Study

March 24, 2025 updated by: Kiran Athreya, Children's Hospital of Orange County

Buckets Vs Braces: is Throw Count a Preventative Measure for Injury in Youth Throwers?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County

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

  • Child

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bucket Group
Individuals assigned to this group will limit their throw count by periodically placing the ball in a bucket over study duration
Other: Bucket Group
This Bucket Intervention is behavioral and studies the effect of players limiting their throw count during practice to reduce pain occurrence
Active Comparator: Brace Group
The participants in the brace group will be asked to wear an arm brace during baseball practice for the duration of the study
Device: Brace Group
The Brace intervention studies the use of players using an elbow throwing brace during practice to reduce the occurrence of pain
No Intervention: Control
Participants in this group will continue playing baseball with no intervention and serve as a comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

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

Sponsor

Children's Hospital of Orange County

Investigators

  • Principal Investigator: Pediatric Orthopedic Surgeon, Children's Hospital of Orange County

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 (Actual)

March 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BvB2212173

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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