Buckets vs. Braces Prospective Study

NCT ID: NCT06904430

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Elbow Pain Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bucket Group

Individuals assigned to this group will limit their throw count by periodically placing the ball in a bucket over study duration

Group Type EXPERIMENTAL

Bucket Group

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Brace Group

Intervention Type DEVICE

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

Control

Participants in this group will continue playing baseball with no intervention and serve as a comparison group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bucket Group

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

Intervention Type OTHER

Brace Group

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Orange County

OTHER

Sponsor Role lead

Responsible Party

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Kiran Athreya

Clinical Research Coordinator II

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pediatric Orthopedic Surgeon

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Orange County

Locations

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Children's Hospital of Orange County

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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BvB2212173

Identifier Type: -

Identifier Source: org_study_id

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