Elbow PainNCT06904430
Buckets vs. Braces Prospective Study
A study testing Bucket Group and Brace Group in people with Elbow Pain and Shoulder Pain, run by Children's Hospital of Orange County at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Elbow Pain, Shoulder Pain
- What is being tested?
- Bucket Group and Brace Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
Official title: 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.
- Conditions
- Elbow Pain, Shoulder Pain
- Being tested
- Bucket Group, Brace Group
- Keywords
- Buckets vs. Braces
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bucket GroupOther
This Bucket Intervention is behavioral and studies the effect of players limiting their throw count during practice to reduce pain occurrence
Brace GroupDevice
The Brace intervention studies the use of players using an elbow throwing brace during practice to reduce the occurrence of pain
| Study group | Role | What they receive |
|---|---|---|
| Bucket Group | Experimental | Individuals assigned to this group will limit their throw count by periodically placing the ball in a bucket over study duration Receives: 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 Receives: Device: Brace Group |
| Control | No intervention | Participants in this group will continue playing baseball with no intervention and serve as a comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
To identify quality of life/patient and family satisfaction with the use of limiting throw count
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Mar 2023
- Primary completion30 Apr 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Athreya, Children's Hospital of Orange County
- Investigators
- Pediatric Orthopedic Surgeon, Principal investigator, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904430
- Sponsor's protocol ID
- BvB2212173
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buckets vs Braces: Is Throw Count a Preventative Measure for Injury in Youth Throwers?
- ClinicalTrials.gov ID
- NCT06904430
- Acronym / sponsor ID
- BvB2212173
- Conditions
- Elbow Pain, Shoulder Pain
- Keywords
- Buckets vs. Braces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bucket Group | Experimental | Other: Bucket GroupIndividuals assigned to this group will limit their throw count by periodically placing the ball in a bucket over study duration |
| Brace Group | Active comparator | Device: Brace GroupThe participants in the brace group will be asked to wear an arm brace during baseball practice for the duration of the study |
| Control | No intervention | –Participants in this group will continue playing baseball with no intervention and serve as a comparison group. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bucket GroupThis Bucket Intervention is behavioral and studies the effect of players limiting their throw count during practice to reduce pain occurrence | Other | Bucket Group |
| Brace GroupThe Brace intervention studies the use of players using an elbow throwing brace during practice to reduce the occurrence of pain | Device | Brace Group |
Primary outcome
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.
1 secondary outcome
To identify quality of life/patient and family satisfaction with the use of limiting throw count
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pediatric Orthopedic Surgeon principal investigator
Children's Hospital of Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bucket Group and Brace Group in people with Elbow Pain and Shoulder Pain, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.