NCT04453878

Brief Summary

Background: Glenohumeral internal rotation deficit (GIRD) is believed to be one of the risk factors contributing to shoulder injuries. In addition, athletes with GIRD of greater than 20° appear to be at a greater risk for the shoulder injuries and surgery. Recently, GIRD can be divided in anatomical GIRD and pathological GIRD (pGIRD). The dominant arm of the athletes with pGIRD have not only humeral retrotorsion (HR) but also stiffer posterior capsule. The soft-tissue effect is believed to be the key point in pathological cascade of throwers. Therefore, the previous studies use gross GIRD as a risk factor may be modified by ultrasound-guide corrected GIRD. Objective: There are 4 objectives for the present study: (1) to investigate the Receiver operating characteristic (ROC) curves of the gross GIRD; (2) to investigate the ROC curves of the ultrasound-guide corrected GIRD; (3) to compare the area under curve (AUC) of the two methods; (4) to compare the gross GIRD and the ultrasound-guide corrected GIRD in baseball players. Design: Baseball players who have played baseball for at least 1 year and still active in training or competition will be recruited in this study. Participant characteristics will be collected by the main assessor, including age, gender, height, weight, dominant arm, practice time, years of playing baseball. Performance/function will be assessed via a Kerlan-Jobe Orthopaedic Clinic shoulder and elbow (KJOC) self-report questionnaire. The shoulder rotation ROM, ultrasound examination including ultrasound-corrected GIRD and posterior capsular thickness and posterior shoulder tightness will also be measured. we will follow subjects for a season. Once the injury occurs, deterioration or at the end of the season, we will collect the data again. Main outcome measures: The shoulder rotation ROM, ultrasound examination and posterior shoulder tightness are main outcomes of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

June 22, 2020

Last Update Submit

October 16, 2023

Conditions

Keywords

shoulder injury,ultrasound

Outcome Measures

Primary Outcomes (2)

  • alteration of ultrasound-guide corrected GIRD

    The participants will be told to supine with 90° of shoulder abduction and elbow flexion. The main assessor places the transducer on the subject's anterior shoulder, perpendicular to the long axis of the humerus in the frontal plane. Then, the humerus will be manually rotated by the assessor for the bicipital groove being centered on the ultrasound image. The ultrasound is then positioned, aided by use of a grid on the ultrasound display. Thus, a line connecting the greater and lesser tubercles can be parallel to the horizontal plane. Last, the second assessor places a digital inclinometer on the ulnar side of the forearm to record the forearm inclination angle, defining the amount of humeral retroversion. This measurement will be repeated 3 times bilaterally and the average will be used for data analysis. The equation of ultrasound-guide corrected GIRD will be gross GIRD minus difference of humeral retroversion between dominant and non-dominant arm.

    through study completion, an average of 1 year

  • alteration of posterior capsular thickness

    The subject will be positioned upright in a chair with the arm at the side and forearm resting on the thigh. The examiner positions a transducer on the posterior shoulder, visualizing the glenoid labrum, humeral head, rotator cuff, and posterior capsule, defined as the tissue immediately lateral to the tip of the labrum between the humeral head and rotator cuff. When the capsule is identified, the image is paused, and the capsule thickness will be measured by built-in caliper. The imaging procedure will be repeated 3 times, and an average thickness will be determined. This measurement will be taken bilaterally for all subjects.

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • change of shoulder rotation ROM

    through study completion, an average of 1 year

  • Injury assessment and classification

    up to 24 weeks

  • change of posterior shoulder tightness

    through study completion, an average of 1 year

  • change of Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow score (KJOC)

    through study completion, an average of 1 year

  • days in the disable list

    through study completion, an average of 1 year

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A baseball team usually consists of 30 to 40 players. Therefore, we will recruit 3 or 4 local baseball teams in Taipei and New Taipei city. Based on the consideration of schedule between baseball teams and our research team, We will collect 7 subjects per day and the recruitment time will last for about a month.

You may qualify if:

  • Age range from 12 to 40 years old.
  • Playing baseball for at least 1 year.
  • Still active in training or competition.
  • The frequency of training or game should be at least 3 times per week, 3 hours per time.

You may not qualify if:

  • Subjects with shoulder pain onset due to trauma.
  • A history of shoulder fractures or dislocation.
  • Cervical radiculopathy.
  • Degenerative joint disease of the shoulder.
  • Surgical interventions on the shoulder.
  • Inflammatory arthropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 1. Olsen SJ, 2nd, Fleisig GS, Dun S, Loftice J, Andrews JR. Risk factors for shoulder and elbow injuries in adolescent baseball pitchers. The American journal of sports medicine 2006;34:905-12. 2. Makhni EC, Morrow ZS, Luchetti TJ, Mishra-Kalyani PS, Gualtieri AP, Lee RW, et al. Arm pain in youth baseball players: a survey of healthy players. The American journal of sports medicine 2015;43:41-6. 3. Saper MG, Pierpoint LA, Liu W, Comstock RD, Polousky JD, Andrews JR. Epidemiology of Shoulder and Elbow Injuries Among United States High School Baseball Players: School Years 2005-2006 Through 2014-2015. The American journal of sports medicine 2018;46:37-43. 4. Dick R, Sauers EL, Agel J, Keuter G, Marshall SW, McCarty K, et al. Descriptive epidemiology of collegiate men's baseball injuries: National Collegiate Athletic Association Injury Surveillance System, 1988-1989 through 2003-2004. J Athl Train 2007;42:183-93. 5. Conte S, Camp CL, Dines JS. Injury Trends in Major League Baseball Over 18 Seasons: 1998-2015. Am J Orthop (Belle Mead NJ) 2016;45:116-23. 6. Lin DJ, Wong TT, Kazam JK. Shoulder Injuries in the Overhead-Throwing Athlete: Epidemiology, Mechanisms of Injury, and Imaging Findings. Radiology 2018;286:370-87. 7. Tyler TF, Nicholas SJ, Lee SJ, Mullaney M, McHugh MP. Correction of posterior shoulder tightness is associated with symptom resolution in patients with internal impingement. The American journal of sports medicine 2010;38:114-9. 8. Wilk KE, Macrina LC, Fleisig GS, Porterfield R, Simpson CD, 2nd, Harker P, et al. Correlation of glenohumeral internal rotation deficit and total rotational motion to shoulder injuries in professional baseball pitchers. The American journal of sports medicine 2011;39:329-35. 9. Harryman DT, 2nd, Sidles JA, Clark JM, McQuade KJ, Gibb TD, Matsen FA, 3rd. Translation of the humeral head on the glenoid with passive glenohumeral motion. The Journal of bone and joint surgery American volume 1990;72:1334-43. 10. Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Physical therapy 2000;80:276-91. 11. Lin JJ, Hanten WP, Olson SL, Roddey TS, Soto-quijano DA, Lim HK, et al. Functional activity characteristics of individuals with shoulder dysfunctions. Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology 2005;15:576-86. 12. Itoi E, Motzkin NE, Morrey BF, An KN. Scapular inclination and inferior stability of the shoulder. Journal of shoulder and elbow surgery 1992;1:131-9. 13. Paley KJ, Jobe FW, Pink MM, Kvitne RS, ElAttrache NS. Arthroscopic findings in the overhand throwing athlete: evidence for posterior internal impingement of the rotator cuff. Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association 2000;16:35-40. 14. Warner JJ, Micheli LJ, Arslanian LE, Kennedy J, Kennedy R. Scapulothoracic motion in normal shoulders and shoulders with glenohumeral instability and impingement syndrome. A study using Moire topographic analysis. Clinical orthopaedics and related research 1992:191-9. 15. Weiser WM, Lee TQ, McMaster WC, McMahon PJ. Effects of simulated scapular protraction on anterior glenohumeral stability. The American journal of sports medicine 1999;27:801-5. 16. Kolber MJ, Hanney WJ. The reliability and concurrent validity of shoulder mobility measurements using a digital inclinometer and goniometer: a technical report. International journal of sports physical therapy 2012;7:306-13.

    BACKGROUND

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jing-Lan Yang, MAMS

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 1, 2020

Study Start

March 1, 2021

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations