Elbow InjuriesNCT02749760
Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers
A study testing Strengthening program and Exercise program in people with Elbow Injuries and Sprain Ulnar Collateral Ligament, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elbow Injuries, Sprain Ulnar Collateral Ligament, Upper Extremity Injuries
- What is being tested?
- Strengthening program and Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2021
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pitchers that are currently on a minor league baseball team.
Who cannot join
- Pitchers that currently have upper extremity injuries or are in active rehab for upper extremity injury.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Effect of Dynamic Stabilizers for Valgus Stability of the Elbow in Professional Baseball Players
This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis (FDS), and wrist flexion strength will be measured and correlated with upper extremity injuries and time missed from pitching. The investigators will also be measuring loss of strength over the season. The goal is to learn whether strength in these muscles prevents UCL injuries and finally whether these muscles can be strengthened to avoid such injuries.
Read the detailed description
The goal of this study is to assess whether the strengths of the secondary muscular stabilizers toward valgus stress at the elbow, the wrist flexors, flexor digitorum superficialis, and pronator teres emanating from the medial epicondyle, affect the incidence of ulnar collateral ligament injuries of the elbows in pitchers. Pitchers in the minor leagues of a single professional baseball club will have the strength of these secondary muscular stabilizers assessed and then correlated to ulnar collateral ligament injuries and time missed from baseball season and subsequent seasons. A secondary goal is to assess whether strengthening exercises targeted toward these muscular stabilizers of the elbow can decrease the incidence of ulnar collateral ligament injuries in young baseball pitchers. This could impact the field by changing the emphasis from reconstruction and rehabilitation of ulnar collateral ligament injuries to prevention.
- Conditions
- Elbow Injuries, Sprain Ulnar Collateral Ligament, Upper Extremity Injuries, Strain of Ulnar Collateral Ligament, Complete Tear Ulnar Collateral Ligament
- Being tested
- Strengthening program, Exercise program
- Keywords
- Ulnar collateral ligament, elbow injuries, dynamic elbow stabilizers, Tommy John's procedure, elbow injuries in pitchers
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening programOther
Strengthening programs may be established to target the stabilizers of the elbows
Exercise programOther
Exercise program may be established to target the stabilizers of the elbows.
| Study group | Role | What they receive |
|---|---|---|
| Minor league pitchers | Other | Minor league pitchers from a single professional baseball organization. Strength tests of the elbows will be administered at spring training and end of season for 5 years. If strength correlates to injury, strengthening and exercise programs may be established to target the stabilizers of the elbows. Receives: Other: Strengthening program; Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Correlation of Strength to UCL Injuries in Minor League Pitchers
After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.
Measured: 5 years
Secondary outcomes (1)
The Diminution of Strength in Minor League Pitchers
We will measure the diminution of strength over the course of a baseball season.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Elbow InjuriesStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Toby, MD, University of Kansas Medical Center
- Investigators
- E B Toby, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749760
- Sponsor's protocol ID
- STUDY00000174
- Status last verified
- Sep 2024
- First submitted
- 11 Apr 2016
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anz AW, Bushnell BD, Griffin LP, Noonan TJ, Torry MR, Hawkins RJ. Correlation of torque and elbow injury in professional baseball pitchers. Am J Sports Med. 2010 Jul;38(7):1368-74. doi: 10.1177/0363546510363402. Epub 2010 Apr 16.
PubMed 20400752Azar FM, Andrews JR, Wilk KE, Groh D. Operative treatment of ulnar collateral ligament injuries of the elbow in athletes. Am J Sports Med. 2000 Jan-Feb;28(1):16-23. doi: 10.1177/03635465000280011401.
PubMed 10653538Bruce JR, Andrews JR. Ulnar collateral ligament injuries in the throwing athlete. J Am Acad Orthop Surg. 2014 May;22(5):315-25. doi: 10.5435/JAAOS-22-05-315.
PubMed 24788447Bruce JR, Hess R, Joyner P, Andrews JR. How much valgus instability can be expected with ulnar collateral ligament (UCL) injuries? A review of 273 baseball players with UCL injuries. J Shoulder Elbow Surg. 2014 Oct;23(10):1521-6. doi: 10.1016/j.jse.2014.05.015.
PubMed 25220199Conte SA, Fleisig GS, Dines JS, Wilk KE, Aune KT, Patterson-Flynn N, ElAttrache N. Prevalence of Ulnar Collateral Ligament Surgery in Professional Baseball Players. Am J Sports Med. 2015 Jul;43(7):1764-9. doi: 10.1177/0363546515580792. Epub 2015 Apr 29.
PubMed 25925603Costantino C, Vaienti E, Pogliacomi F. Evaluation of the peak torque, total work, average power of flexor-estensor and prono-supinator muscles of the elbow in baseball players. Acta Biomed. 2003 Aug;74(2):88-92.
PubMed 14509917Davidson PA, Pink M, Perry J, Jobe FW. Functional anatomy of the flexor pronator muscle group in relation to the medial collateral ligament of the elbow. Am J Sports Med. 1995 Mar-Apr;23(2):245-50. doi: 10.1177/036354659502300220.
PubMed 7778713Dugas JR, Ostrander RV, Cain EL, Kingsley D, Andrews JR. Anatomy of the anterior bundle of the ulnar collateral ligament. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):657-60. doi: 10.1016/j.jse.2006.11.009. Epub 2007 Jun 20.
PubMed 17583541Erickson BJ, Chalmers PN, Bush-Joseph CA, Verma NN, Romeo AA. Ulnar Collateral Ligament Reconstruction of the Elbow: A Systematic Review of the Literature. Orthop J Sports Med. 2015 Dec 9;3(12):2325967115618914. doi: 10.1177/2325967115618914. eCollection 2015 Dec.
PubMed 26740956Erickson BJ, Gupta AK, Harris JD, Bush-Joseph C, Bach BR, Abrams GD, San Juan AM, Cole BJ, Romeo AA. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014 Mar;42(3):536-43. doi: 10.1177/0363546513510890. Epub 2013 Dec 18.
PubMed 24352622Erickson BJ, Nwachukwu BU, Rosas S, Schairer WW, McCormick FM, Bach BR Jr, Bush-Joseph CA, Romeo AA. Trends in Medial Ulnar Collateral Ligament Reconstruction in the United States: A Retrospective Review of a Large Private-Payer Database From 2007 to 2011. Am J Sports Med. 2015 Jul;43(7):1770-4. doi: 10.1177/0363546515580304.
PubMed 26129959Fleisig GS, Andrews JR, Dillman CJ, Escamilla RF. Kinetics of baseball pitching with implications about injury mechanisms. Am J Sports Med. 1995 Mar-Apr;23(2):233-9. doi: 10.1177/036354659502300218.
PubMed 7778711Hamilton CD, Glousman RE, Jobe FW, Brault J, Pink M, Perry J. Dynamic stability of the elbow: electromyographic analysis of the flexor pronator group and the extensor group in pitchers with valgus instability. J Shoulder Elbow Surg. 1996 Sep-Oct;5(5):347-54. doi: 10.1016/s1058-2746(96)80065-6.
PubMed 8933456Haugstvedt JR, Berger RA, Berglund LJ. A mechanical study of the moment-forces of the supinators and pronators of the forearm. Acta Orthop Scand. 2001 Dec;72(6):629-34. doi: 10.1080/000164701317269076.
PubMed 11817880Jones KJ, Dines JS, Rebolledo BJ, Weeks KD, Williams RJ, Dines DM, Altchek DW. Operative management of ulnar collateral ligament insufficiency in adolescent athletes. Am J Sports Med. 2014 Jan;42(1):117-21. doi: 10.1177/0363546513507695. Epub 2013 Oct 21.
PubMed 24145949
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Stabilizers for Valgus Stability of the Elbow in Professional Baseball Players
- ClinicalTrials.gov ID
- NCT02749760
- Acronym / sponsor ID
- STUDY00000174
- Conditions
- Elbow Injuries, Sprain Ulnar Collateral Ligament, Upper Extremity Injuries, Strain of Ulnar Collateral Ligament, Complete Tear Ulnar Collateral Ligament
- Keywords
- Ulnar collateral ligament, elbow injuries, dynamic elbow stabilizers, Tommy John's procedure, elbow injuries in pitchers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis (FDS), and wrist flexion strength will be measured and correlated with upper extremity injuries and time missed from pitching. The investigators will also be measuring loss of strength over the season. The goal is to learn whether strength in these muscles prevents UCL injuries and finally whether these muscles can be strengthened to avoid such injuries.
Detailed description
The goal of this study is to assess whether the strengths of the secondary muscular stabilizers toward valgus stress at the elbow, the wrist flexors, flexor digitorum superficialis, and pronator teres emanating from the medial epicondyle, affect the incidence of ulnar collateral ligament injuries of the elbows in pitchers. Pitchers in the minor leagues of a single professional baseball club will have the strength of these secondary muscular stabilizers assessed and then correlated to ulnar collateral ligament injuries and time missed from baseball season and subsequent seasons. A secondary goal is to assess whether strengthening exercises targeted toward these muscular stabilizers of the elbow can decrease the incidence of ulnar collateral ligament injuries in young baseball pitchers. This could impact the field by changing the emphasis from reconstruction and rehabilitation of ulnar collateral ligament injuries to prevention.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minor league pitchers | Other | Other: Strengthening program, Other: Exercise programMinor league pitchers from a single professional baseball organization. Strength tests of the elbows will be administered at spring training and end of season for 5 years. If strength correlates to injury, strengthening and exercise programs may be established to target the stabilizers of the elbows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pitchers that are currently on a minor league baseball team.
Key exclusion criteria (1 listed)
- Pitchers that currently have upper extremity injuries or are in active rehab for upper extremity injury.
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 |
|---|---|---|
| Strengthening programStrengthening programs may be established to target the stabilizers of the elbows | Other | Minor league pitchers |
| Exercise programExercise program may be established to target the stabilizers of the elbows. | Other | Minor league pitchers |
Primary outcome
The Correlation of Strength to UCL Injuries in Minor League Pitchers
Time frame: 5 years
After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.
1 secondary outcome
The Diminution of Strength in Minor League Pitchers
Time frame: 5 years
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 27 Sep 2024.
- Background: PubMed 20400752Anz AW, Bushnell BD, Griffin LP, Noonan TJ, Torry MR, Hawkins RJ. Correlation of torque and elbow injury in professional baseball pitchers. Am J Sports Med. 2010 Jul;38(7):1368-74. doi: 10.1177/0363546510363402. Epub 2010 Apr 16.
- Background: PubMed 10653538Azar FM, Andrews JR, Wilk KE, Groh D. Operative treatment of ulnar collateral ligament injuries of the elbow in athletes. Am J Sports Med. 2000 Jan-Feb;28(1):16-23. doi: 10.1177/03635465000280011401.
- Background: PubMed 24788447Bruce JR, Andrews JR. Ulnar collateral ligament injuries in the throwing athlete. J Am Acad Orthop Surg. 2014 May;22(5):315-25. doi: 10.5435/JAAOS-22-05-315.
- Background: PubMed 25220199Bruce JR, Hess R, Joyner P, Andrews JR. How much valgus instability can be expected with ulnar collateral ligament (UCL) injuries? A review of 273 baseball players with UCL injuries. J Shoulder Elbow Surg. 2014 Oct;23(10):1521-6. doi: 10.1016/j.jse.2014.05.015.
- Background: PubMed 25925603Conte SA, Fleisig GS, Dines JS, Wilk KE, Aune KT, Patterson-Flynn N, ElAttrache N. Prevalence of Ulnar Collateral Ligament Surgery in Professional Baseball Players. Am J Sports Med. 2015 Jul;43(7):1764-9. doi: 10.1177/0363546515580792. Epub 2015 Apr 29.
- Background: PubMed 14509917Costantino C, Vaienti E, Pogliacomi F. Evaluation of the peak torque, total work, average power of flexor-estensor and prono-supinator muscles of the elbow in baseball players. Acta Biomed. 2003 Aug;74(2):88-92.
- Background: PubMed 7778713Davidson PA, Pink M, Perry J, Jobe FW. Functional anatomy of the flexor pronator muscle group in relation to the medial collateral ligament of the elbow. Am J Sports Med. 1995 Mar-Apr;23(2):245-50. doi: 10.1177/036354659502300220.
- Background: PubMed 17583541Dugas JR, Ostrander RV, Cain EL, Kingsley D, Andrews JR. Anatomy of the anterior bundle of the ulnar collateral ligament. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):657-60. doi: 10.1016/j.jse.2006.11.009. Epub 2007 Jun 20.
- Background: PubMed 26740956Erickson BJ, Chalmers PN, Bush-Joseph CA, Verma NN, Romeo AA. Ulnar Collateral Ligament Reconstruction of the Elbow: A Systematic Review of the Literature. Orthop J Sports Med. 2015 Dec 9;3(12):2325967115618914. doi: 10.1177/2325967115618914. eCollection 2015 Dec.
- Background: PubMed 24352622Erickson BJ, Gupta AK, Harris JD, Bush-Joseph C, Bach BR, Abrams GD, San Juan AM, Cole BJ, Romeo AA. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014 Mar;42(3):536-43. doi: 10.1177/0363546513510890. Epub 2013 Dec 18.
- Background: PubMed 26129959Erickson BJ, Nwachukwu BU, Rosas S, Schairer WW, McCormick FM, Bach BR Jr, Bush-Joseph CA, Romeo AA. Trends in Medial Ulnar Collateral Ligament Reconstruction in the United States: A Retrospective Review of a Large Private-Payer Database From 2007 to 2011. Am J Sports Med. 2015 Jul;43(7):1770-4. doi: 10.1177/0363546515580304.
- Background: PubMed 7778711Fleisig GS, Andrews JR, Dillman CJ, Escamilla RF. Kinetics of baseball pitching with implications about injury mechanisms. Am J Sports Med. 1995 Mar-Apr;23(2):233-9. doi: 10.1177/036354659502300218.
- Individual participant dataSharing planned: No
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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.
E B Toby, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening program and Exercise program in people with Elbow Injuries and Sprain Ulnar Collateral Ligament, run by University of Kansas Medical Center 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 1 inclusion and 1 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 27 Sep 2024. 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?
The Correlation of Strength to UCL Injuries in Minor League Pitchers (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749760, which also lists 23 linked publications.
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 27 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.