Shoulder Posterior Capsular ContractureSafethrowNCT01065181
Youth Throwers Respond to Stretching
An observational study of Shoulder Posterior Capsular Contracture, run by Metzger, Charles, M.D..
Trial summary
The purpose of this study is to document the rates of youth baseball player demographics, incidence of arm pain, usage of different pitch types, and degree of internal rotation contracture in the throwing versus the non-throwing shoulder. Read more about this study
- Who is it for?
- Ages 8 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Posterior Capsular Contracture
- How many people
- 1,261 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Sep 2019
- Phase
- Observational
- 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 15 years
- Men only
- Healthy volunteers accepted
- Child
Study population: 1261 male baseball players ages 8 to 15
Who may be able to join
- male
- baseball player
- ages 8 to 15
Who cannot join
- female (suspected hormonal/gender influences on capsular elasticity)
- prior throwing arm surgery
About this study
Official title: Shoulder Posterior Capsular Contracture in Youth Baseball Players: It Can be Improved by Stretching
The purpose of this study is to document the rates of youth baseball player demographics, incidence of arm pain, usage of different pitch types, and degree of internal rotation contracture in the throwing versus the non-throwing shoulder. We followed a subgroup of players for a year to see if a particular stretch would help reduce the internal rotation contracture.
Read the detailed description
Introduction: Overhead throwing can cause contracture of the shoulder posterior-inferior glenohumeral ligament which can lead to injuries such as superior labral tears. We show that instruction on stretching can favorably alter progression of posterior contractures.
Methods: 1261 male baseball players ages 7-15 completed a questionnaire and shoulder examinations. Measurements of rotation of both shoulders were made with the subjects in the supine position with the scapula stabilized. Glenohumeral internal rotation deficit (GIRD) was calculated. Pitch type and player position, among other variables, were recorded. The prospective cohort was 175 players who were examined twice a year apart. Players with excessive GIRD (exGIRD) were given stretching instruction, and the control group was those without exGIRD who were not given instruction. Change in GIRD as a result of this intervention was documented.
- Conditions
- Shoulder Posterior Capsular Contracture
- Keywords
- shoulder, posterior inferior glenohumeral ligament, posterior capsule, capsular contracture, baseball, throwing injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of decrease in internal rotation contracture of the shoulder
GIRD is the Glenohumeral Internal Rotation Deficit. It is the difference in the internal rotation of the throwing shoulder compared to the non-throwing shoulder
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Shoulder Posterior Capsular ContractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metzger, Charles, M.D.
- Responsible party
- Principal investigator, Charles Metzger, M.D., Metzger, Charles, M.D.
- Investigators
- Charles L Metzger, MD, Principal investigator, Memorial Hermann Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065181
- Sponsor's protocol ID
- Safethrow01
- Acronym
- Safethrow
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2010
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lyman S, Fleisig GS. Baseball injuries. Med Sport Sci. 2005;49:9-30. doi: 10.1159/000085340.
PubMed 16247260Kerut EK, Kerut DG, Fleisig GS, Andrews JR. Prevention of arm injury in youth baseball pitchers. J La State Med Soc. 2008 Mar-Apr;160(2):95-8.
PubMed 18681352Awan R, Smith J, Boon AJ. Measuring shoulder internal rotation range of motion: a comparison of 3 techniques. Arch Phys Med Rehabil. 2002 Sep;83(9):1229-34. doi: 10.1053/apmr.2002.34815.
PubMed 12235602Lyman S, Fleisig GS, Waterbor JW, Funkhouser EM, Pulley L, Andrews JR, Osinski ED, Roseman JM. Longitudinal study of elbow and shoulder pain in youth baseball pitchers. Med Sci Sports Exerc. 2001 Nov;33(11):1803-10. doi: 10.1097/00005768-200111000-00002.
PubMed 11689728Lyman S, Fleisig GS, Andrews JR, Osinski ED. Effect of pitch type, pitch count, and pitching mechanics on risk of elbow and shoulder pain in youth baseball pitchers. Am J Sports Med. 2002 Jul-Aug;30(4):463-8. doi: 10.1177/03635465020300040201.
PubMed 12130397Dun S, Loftice J, Fleisig GS, Kingsley D, Andrews JR. A biomechanical comparison of youth baseball pitches: is the curveball potentially harmful? Am J Sports Med. 2008 Apr;36(4):686-92. doi: 10.1177/0363546507310074. Epub 2007 Nov 30.
PubMed 18055920Fleisig GS, Weber A, Hassell N, Andrews JR. Prevention of elbow injuries in youth baseball pitchers. Curr Sports Med Rep. 2009 Sep-Oct;8(5):250-4. doi: 10.1249/JSR.0b013e3181b7ee5f.
PubMed 19741352Nissen CW, Westwell M, Ounpuu S, Patel M, Solomito M, Tate J. A biomechanical comparison of the fastball and curveball in adolescent baseball pitchers. Am J Sports Med. 2009 Aug;37(8):1492-8. doi: 10.1177/0363546509333264. Epub 2009 May 15.
PubMed 19448049Dwelly PM, Tripp BL, Tripp PA, Eberman LE, Gorin S. Glenohumeral rotational range of motion in collegiate overhead-throwing athletes during an athletic season. J Athl Train. 2009 Nov-Dec;44(6):611-6. doi: 10.4085/1062-6050-44.6.611.
PubMed 19911087Bach HG, Goldberg BA. Posterior capsular contracture of the shoulder. J Am Acad Orthop Surg. 2006 May;14(5):265-77. doi: 10.5435/00124635-200605000-00002.
PubMed 16675620Grossman MG, Tibone JE, McGarry MH, Schneider DJ, Veneziani S, Lee TQ. A cadaveric model of the throwing shoulder: a possible etiology of superior labrum anterior-to-posterior lesions. J Bone Joint Surg Am. 2005 Apr;87(4):824-31. doi: 10.2106/JBJS.D.01972.
PubMed 15805213Trakis JE, McHugh MP, Caracciolo PA, Busciacco L, Mullaney M, Nicholas SJ. Muscle strength and range of motion in adolescent pitchers with throwing-related pain: implications for injury prevention. Am J Sports Med. 2008 Nov;36(11):2173-8. doi: 10.1177/0363546508319049. Epub 2008 Jul 2.
PubMed 18596197Nakamizo H, Nakamura Y, Nobuhara K, Yamamoto T. Loss of glenohumeral internal rotation in little league pitchers: a biomechanical study. J Shoulder Elbow Surg. 2008 Sep-Oct;17(5):795-801. doi: 10.1016/j.jse.2008.02.013. Epub 2008 Jun 20.
PubMed 18571440Olsen SJ 2nd, Fleisig GS, Dun S, Loftice J, Andrews JR. Risk factors for shoulder and elbow injuries in adolescent baseball pitchers. Am J Sports Med. 2006 Jun;34(6):905-12. doi: 10.1177/0363546505284188. Epub 2006 Feb 1.
PubMed 16452269Klingele KE, Kocher MS. Little league elbow: valgus overload injury in the paediatric athlete. Sports Med. 2002;32(15):1005-15. doi: 10.2165/00007256-200232150-00004.
PubMed 12457420
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Posterior Capsular Contracture in Youth Baseball Players: It Can be Improved by Stretching
- ClinicalTrials.gov ID
- NCT01065181
- Acronym / sponsor ID
- Safethrow / Safethrow01
- Conditions
- Shoulder Posterior Capsular Contracture
- Keywords
- shoulder, posterior inferior glenohumeral ligament, posterior capsule, capsular contracture, baseball, throwing injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,261 participants (actual)
- Lead sponsor
- Metzger, Charles, M.D.
- Study start
- Jan 2008 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 9 Feb 2010 (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.
The purpose of this study is to document the rates of youth baseball player demographics, incidence of arm pain, usage of different pitch types, and degree of internal rotation contracture in the throwing versus the non-throwing shoulder. We followed a subgroup of players for a year to see if a particular stretch would help reduce the internal rotation contracture.
Detailed description
Introduction: Overhead throwing can cause contracture of the shoulder posterior-inferior glenohumeral ligament which can lead to injuries such as superior labral tears. We show that instruction on stretching can favorably alter progression of posterior contractures.
Methods: 1261 male baseball players ages 7-15 completed a questionnaire and shoulder examinations. Measurements of rotation of both shoulders were made with the subjects in the supine position with the scapula stabilized. Glenohumeral internal rotation deficit (GIRD) was calculated. Pitch type and player position, among other variables, were recorded. The prospective cohort was 175 players who were examined twice a year apart. Players with excessive GIRD (exGIRD) were given stretching instruction, and the control group was those without exGIRD who were not given instruction. Change in GIRD as a result of this intervention was documented.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1261 male baseball players ages 8 to 15
Key inclusion criteria (3 listed)
- male
- baseball player
- ages 8 to 15
Key exclusion criteria (2 listed)
- female (suspected hormonal/gender influences on capsular elasticity)
- prior throwing arm surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of decrease in internal rotation contracture of the shoulder
Time frame: One year
GIRD is the Glenohumeral Internal Rotation Deficit. It is the difference in the internal rotation of the throwing shoulder compared to the non-throwing shoulder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Background: PubMed 16247260Lyman S, Fleisig GS. Baseball injuries. Med Sport Sci. 2005;49:9-30. doi: 10.1159/000085340.
- Background: PubMed 18681352Kerut EK, Kerut DG, Fleisig GS, Andrews JR. Prevention of arm injury in youth baseball pitchers. J La State Med Soc. 2008 Mar-Apr;160(2):95-8.
- Results publication: PubMed 12235602Awan R, Smith J, Boon AJ. Measuring shoulder internal rotation range of motion: a comparison of 3 techniques. Arch Phys Med Rehabil. 2002 Sep;83(9):1229-34. doi: 10.1053/apmr.2002.34815.
- Results publication: PubMed 11689728Lyman S, Fleisig GS, Waterbor JW, Funkhouser EM, Pulley L, Andrews JR, Osinski ED, Roseman JM. Longitudinal study of elbow and shoulder pain in youth baseball pitchers. Med Sci Sports Exerc. 2001 Nov;33(11):1803-10. doi: 10.1097/00005768-200111000-00002.
- Results publication: PubMed 12130397Lyman S, Fleisig GS, Andrews JR, Osinski ED. Effect of pitch type, pitch count, and pitching mechanics on risk of elbow and shoulder pain in youth baseball pitchers. Am J Sports Med. 2002 Jul-Aug;30(4):463-8. doi: 10.1177/03635465020300040201.
- Results publication: PubMed 18055920Dun S, Loftice J, Fleisig GS, Kingsley D, Andrews JR. A biomechanical comparison of youth baseball pitches: is the curveball potentially harmful? Am J Sports Med. 2008 Apr;36(4):686-92. doi: 10.1177/0363546507310074. Epub 2007 Nov 30.
- Results publication: PubMed 19741352Fleisig GS, Weber A, Hassell N, Andrews JR. Prevention of elbow injuries in youth baseball pitchers. Curr Sports Med Rep. 2009 Sep-Oct;8(5):250-4. doi: 10.1249/JSR.0b013e3181b7ee5f.
- Results publication: PubMed 19448049Nissen CW, Westwell M, Ounpuu S, Patel M, Solomito M, Tate J. A biomechanical comparison of the fastball and curveball in adolescent baseball pitchers. Am J Sports Med. 2009 Aug;37(8):1492-8. doi: 10.1177/0363546509333264. Epub 2009 May 15.
- Results publication: PubMed 19911087Dwelly PM, Tripp BL, Tripp PA, Eberman LE, Gorin S. Glenohumeral rotational range of motion in collegiate overhead-throwing athletes during an athletic season. J Athl Train. 2009 Nov-Dec;44(6):611-6. doi: 10.4085/1062-6050-44.6.611.
- Results publication: PubMed 16675620Bach HG, Goldberg BA. Posterior capsular contracture of the shoulder. J Am Acad Orthop Surg. 2006 May;14(5):265-77. doi: 10.5435/00124635-200605000-00002.
- Results publication: PubMed 15805213Grossman MG, Tibone JE, McGarry MH, Schneider DJ, Veneziani S, Lee TQ. A cadaveric model of the throwing shoulder: a possible etiology of superior labrum anterior-to-posterior lesions. J Bone Joint Surg Am. 2005 Apr;87(4):824-31. doi: 10.2106/JBJS.D.01972.
- Results publication: PubMed 18596197Trakis JE, McHugh MP, Caracciolo PA, Busciacco L, Mullaney M, Nicholas SJ. Muscle strength and range of motion in adolescent pitchers with throwing-related pain: implications for injury prevention. Am J Sports Med. 2008 Nov;36(11):2173-8. doi: 10.1177/0363546508319049. Epub 2008 Jul 2.
- Youth baseball player reference site for help in reducing pain and injury from throwingLink provided by the sponsor.
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.
Charles L Metzger, MD principal investigator
Memorial Hermann Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Posterior Capsular Contracture, run by Metzger, Charles, M.D..
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 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Degree of decrease in internal rotation contracture of the shoulder (time frame: One year). 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 NCT01065181, which also lists 17 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 Mar 2018.