Shoulder PainNCT02024893
Range of Motion, Humeral Retroversion and Rotator Cuff (RC) Muscle Strength of the Shoulder in Overhead Athletes
An observational study of Shoulder Pain, run by Wingate Institute at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Observational study
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Aug 2016
- How long will I take part?
- 12 Months
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Elite athletes consisiting of the national tean roster in several overhead sports; Women's volleyball Men's handball Women's water- polo
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ribstein center for sports medicine and research at the Wingate Institute Institue
Netanya, 42902
About this study
Official title: Range of Motion, Humeral Retroversion and RC Muscle Strength in the Shoulder of Overhead Athletes
- 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.
Read the detailed 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).
- Conditions
- Shoulder Pain
- Being tested
- Observational study
- Keywords
- Humeral retroversion, dynamic control ratio, GIRD
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observation and type of data collected are listged in detail under 'description"
| Study group | Role | What they receive |
|---|---|---|
| National womens water- polo team | Observational study-members of the national womens waterpolo team participating in formal team training and tournaments for the 2014-2015 season. Receives: Other: Observational study | |
| National mens handball team | Observational study-Twenty men , members of the national , over 18 years old handball team preparing for the european championships for summer 2014 Receives: Other: Observational study | |
| National womens volleyball team | 20 players who are part of the women's national olympic volleyball team Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Wingate Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eyal Shargal, Wingate Institute
- Investigators
- Eyal Shargal, PhD, Study director, Wingate Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024893
- Sponsor's protocol ID
- WingateShoulder1
- Status last verified
- Nov 2017
- First submitted
- 21 Dec 2013
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Range of Motion, Humeral Retroversion and RC Muscle Strength in the Shoulder of Overhead Athletes
- ClinicalTrials.gov ID
- NCT02024893
- Acronym / sponsor ID
- WingateShoulder1
- Conditions
- Shoulder Pain
- Keywords
- Humeral retroversion, dynamic control ratio, GIRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wingate InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Dec 2013 (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.
- 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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| National womens water- polo team | – | Other: Observational studyObservational study-members of the national womens waterpolo team participating in formal team training and tournaments for the 2014-2015 season. |
| National mens handball team | – | Other: Observational studyObservational study-Twenty men , members of the national , over 18 years old handball team preparing for the european championships for summer 2014 |
| National womens volleyball team | – | Other: Observational study20 players who are part of the women's national olympic volleyball team |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Elite athletes consisiting of the national tean roster in several overhead sports; Women's volleyball Men's handball Women's water- polo
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Observational studyObservation and type of data collected are listged in detail under 'description" | Other | National mens handball team, National womens volleyball team, National womens water- polo team |
Primary outcome
shoulder internal and external range of motion and resulting total range of motion
Time frame: 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.
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.
3 secondary outcomes
Humeral retroversion
Time frame: 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.
isometric external and internal rotator strength
Time frame: 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.
isokinetic, concentric internal and external rotation, Eccentric internal and external rotation
Time frame: 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.
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 13 Nov 2017.
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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.
Eyal Shargal, PhD study director
Wingate Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Wingate Institute at 1 site in Israel.
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 0 inclusion and 3 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 13 Nov 2017. 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 Israel. 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?
shoulder internal and external range of motion and resulting total range of motion (time frame: 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.). 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 13 Nov 2017.