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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02024893
Other study ID # WingateShoulder1
Secondary ID
Status Completed
Phase N/A
First received December 21, 2013
Last updated November 9, 2017
Start date January 2014
Est. completion date August 2016

Study information

Verified date November 2017
Source Wingate Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- Shoulder pain and dysfunction are common problems in overhead sports, due to extreme ranges of motion and repetitive loading. Predisposing factors include inadequate range of motion (ROM), such as a reduction in total ROM or a shift of balance between internal and external rotation. Such a shift may be the result of soft tissue adaptations to the activity demands, or reflect a structural outcome of Humeral retroversion. A shift in the range of motion may be detrimental to the rotator muscle function, which may create another risk factor for shoulder injury.

- The purpose of this study is to document shoulder range of motion, humeral retroversion, rotator muscle strength and fatigue in several groups of overhead athletes undergoing a routine pre season screening once a year, and investigate the interaction between those factors in the different groups.


Description:

At the commencement of training season athletes will receive a detailed explanation and sign an informed concent form.

- Upon enrollment each athlete will fill a personal questionnaire, including injury history. This is done in accordance with a regular screening performed on those teams.

- ROM will be measured in the supine position, as described in detail in the work of Almeida et al, J shoulder Elbow Surg 2013, 22 , 602-607.

- Following the ROM measurement, assessment of Humeral retroversion via Ultrasound will be carried out, as described and validated by Myers J et al, Am J Sports Med, 2012, 40: 1155-1160.

- Strength testing will be then commenced. A structured warm up procedure consisting of 2 sets of rotation exercises using Theraband will be carried out. Following this a pre - set order of testing consisting of isometric- isokinetic concentric, isokinetic eccentric testing will be performed. This order was chosen in order to allow maximal physiologic preparation and safety during testing. The first side to be tested will be determined randomly.

- Isometric testing will be carried out in the seated, 90/90 position with respect to shoulder and elbow. This position was chosen to reflect as closely as possible the functional range of the dominant shoulder during athletic activity. 3 Contractions of 3 second each, external rotation will be performed, followed by 3 contractions of 3 seconds each into internal rotation. Both will be held against a stationary pad.

- Isokinetic testing will commence following a familiarization procedure, with subject positioned according to manufacture's manual and the protocol described by Zanca et al, J Sports Sciences 2011,29 (15):1603-1611.

- Two sets will be performed concentrically, at 60 degrees/second and at 180 deg/second. Eccentric testing will consist of one set utilizing the slow velocity of 60 degrees/sec.

- Outcome measures will consist of total range of motion (TROM), difference in internal rotation (GIRD), external rotation gain (ERG), Humeral retroversion (HRT)- all measured in degrees. Strength measurement will consisit of maximal isometric strength (Newton), isokinetic peak torque for each direction (Newton/Meter) and agonist:antagonist muscle ratios- concentric, eccentric and dynamic control ratio ( Eccentric external rotation/concentric internal rotation).


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 2016
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: Active members of the national team during previous and current season

Exclusion Criteria:

- Shoulder surgeries

- cervical pain or radiating pain into upper extremity limiting athletic participation

- cervical or radiating pain cocurrent with neurological signs, such as diminished reflexes, sensory disturbances or weakness

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study
Observation and type of data collected are listged in detail under 'description"

Locations

Country Name City State
Israel Ribstein center for sports medicine and research at the Wingate Institute Institue Netanya

Sponsors (1)

Lead Sponsor Collaborator
Wingate Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary shoulder internal and external range of motion and resulting total range of motion shoulder rotation range of motion will be measured with subject in supine, shoulder and elbow flexed to 90 degrees, forearm in neutral. One assessor will control humeral head motion and slowly rotate forearm into internal rotation, while other investigator will position a bubble inclinometer in line with ulnar shaft and get the reading. Then procedure repeated into external rotation. single measurement at season commencmen taken as part of pre- season screening battery. This procedures are routinly administered at the begining of training season of each sport , typically during the first week end training camp.
Secondary Humeral retroversion Humeral Retroversion will be measured indirectly, via Diagnostic Ultrasound- this method has been validated and found reliable. Retroversion is calculated by obtaining an angle formed between the line of Ulna-in the position where the proximal Humeral Tubercles are leveled on a horizontal line, and a vertical line parallel to the tubercle plane. Thus the angle received reflects the amount of posterior(retroversion) of the Humeral head. single measurement, taken as part of pre- season screening battery. This procedures are routinly administered at the begining of training season of each sport , typically during the first week end training camp.
Secondary isometric external and internal rotator strength isometric external and isometric internal rotation strength will be evaluated in the seated position, utilizing the Biodex 4pro system seat. Measurement will be performed at shoulder abduction of 85 degrees,and elbow flexed and palm facing forward. The athlete will perform a maximal contraction against the stationary pad and hold it for 3 seconds. Single measurement, taken as part of pre- season screening battery. This procedures are routinly administered at the begining of training season of each sport , typically during the first week end training camp.
Secondary isokinetic, concentric internal and external rotation, Eccentric internal and external rotation With athlete in the same position described for the isometric testing, following a structured warm up and familiarization, the athlete will perform three sets of maximal contractions , in the following sequence:1. Concentric-5 repetitions at a velocity of 60 degrees per second followed by 1 minute rest 2. Concentric-15 repetitions at a velocity of 180 degrees per second followed by 3 minutes of rest 3. Eccentric 5 repetitions at a velocity of 60 degrees per second . The same procedure will be repeated for the other shoulder. order of testing will be randomized. single measurement, taken as part of pre- season screening battery. This procedures are routinly administered at the begining of training season of each sport , typically during the first week end training camp.
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