Buckets vs. Braces Prospective Study

NCT06904430 | Completed DMC

• 1 other identifier: BvB2212173
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elbow Pain; Shoulder Pain

Keywords

Buckets vs. Braces

Outcome Measures

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.

  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 Outcomes (1)

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

  12 weeks

Study Arms (3)

Bucket Group

EXPERIMENTAL

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

Other: Bucket Group

Brace Group

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Bucket Group OTHER

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

Bucket Group

Brace Group DEVICE

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

Brace Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Orange County: lead

Study Sites (1)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Pediatric Orthopedic Surgeon

  Children's Hospital of Orange County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator II

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 1, 2025
• Study Start: March 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 1, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)