Internal Rotation Contracture-shoulderGIRDHNCT02011243
Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players
An observational study of Internal Rotation Contracture-shoulder and Articulation Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Internal Rotation Contracture-shoulder, Articulation Disorders, Athletic Injuries
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is composed of all members of the professional and pre-professional handball clubs in the city of Nîmes, France (the USAM and HBCN clubs). Younger players who are members of the training centers associated with these same clubs will also be included.
Who may be able to join
- The subject or his/her legal guardian must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- The subject is a member of the professional and pre-professional handball clubs in Nîmes, France (the USAM or HBCN clubs) -- OR-- a member of the training centers associated with the same clubs whose parents or legal representatives have given informed consent
Who cannot join
- The subject is under judicial protection, under tutorship or curatorship
- The subject or his/her legal respresentative refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject is pregnant, parturient, or breastfeeding
- The subject has been operated for shoulder instability, regardless of the surgical technique used
- The subject has a history of fracture of the proximal end of the humerus and / or elbow
- The subject has a history of rotator cuff surgery
- The subject has neurological or spinal problems, or has received physiotherapy on the shoulder complex within 30 days prior to the study assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season
The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.
Read the detailed description
The secondary objectives of this study are :
A- To estimate and compare the prevalence of Internal Rotation Deficit within groups
B- To assess the association between the Internal Rotation Deficit and the appearance of a shoulder pain and/or discomfort when throwing
C- To assess the association between Internal Rotation Deficit and the appearance of a shoulder pathology demonstrated by clinical examination by at least one abnormality in one of the following three tests: the arming apprehension test, the relocation test or the O'Brien test
D- Assess changes in values of IRD 2, the ratio IRD 2/GRE 2, and the Total Range of Motion over the training season
E- Evaluate the association between the values of IRD 2 and the appearance of shoulder pain or discomfort when throwing
F- To evaluate the association between IRD 2 values and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
G- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of shoulder pain or discomfort when throwing
H- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
I- To estimate the optimal threshold value of the IRD 2/GRE 2 ratio that would define an Internal Rotation Deficit in a more relevant fashion as compred to the IRD 2 alone
- Keywords
- deficit, internal rotation, gleno humeral articulation, hand ball
- Medical subject headings
- Articulation Disorders, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Professional players, men | This group includes professional, male, handball players meeting study inclusion criteria. | |
| Professional players, women | This group includes professional, female, handball players meeting study inclusion criteria. | |
| Junior players, men | This group includes junior, male, handball players meeting study inclusion criteria. | |
| Junior players, women | This group includes junior, female, handball players meeting study inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°
Measured: 6 months
Secondary outcomes (29)
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Measured: baseline (Day 0)
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Measured: 3 months
Measure of the internal rotation deficit
Measured: baseline (day 0)
Measure of the internal rotation deficit
Measured: 3 months
Measure of the internal rotation deficit
Measured: 6 months
The ratio of DRI 2 / GRE 2
GRE 2 = measure of the external gain in rotation in position 2 Position 2 = dominant arm in abduction at 90°
Measured: baseline (day 0)
The ratio of DRI 2 / GRE 2
Measured: 3 months
The ratio of DRI 2 / GRE 2
Measured: 6 months
Measure of the total range of motion
Measured: baseline (day 0)
Measure of the total range of motion
Measured: 3 months
Measure of the total range of motion
Measured: 6 months
Presence/absence of pain when throwing (yes/no)
Measured: baseline (day 0)
Presence/absence of pain when throwing (yes/no)
Measured: 3 months
Presence/absence of pain when throwing (yes/no)
Measured: 6 months
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Measured: baseline (day 0)
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Measured: 3 months
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Measured: 6 months
Presence/absence of shoulder pathology
Measured: baseline (day 0)
Presence/absence of shoulder pathology
Measured: 3 months
Presence/absence of shoulder pathology
Measured: 6 months
Shoulder clinical exam: the arming apprehension test
Measured: baseline (day 0)
Shoulder clinical exam: the arming apprehension test
Measured: 3 months
Shoulder clinical exam: the arming apprehension test
Measured: 6 months
Shoulder clinical exam: relocation test
Measured: baseline (day 0)
Shoulder clinical exam: relocation test
Measured: 3 months
Shoulder clinical exam: relocation test
Measured: 6 months
Shoulder clinical exam: the O'Brien test
Measured: baseline (day 0)
Shoulder clinical exam: the O'Brien test
Measured: 3 months
Shoulder clinical exam: the O'Brien test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Rotation Contracture-shoulderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Marès, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011243
- Sponsor's protocol ID
- LOCAL/2013/OM-01
- Other IDs
- 2013-A01183-42
- Acronym
- GIRDH
- Status last verified
- Mar 2015
- First submitted
- 9 Dec 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season
- ClinicalTrials.gov ID
- NCT02011243
- Acronym / sponsor ID
- GIRDH / LOCAL/2013/OM-01
- Keywords
- deficit, internal rotation, gleno humeral articulation, hand ball
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 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.
The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.
Detailed description
The secondary objectives of this study are :
A- To estimate and compare the prevalence of Internal Rotation Deficit within groups
B- To assess the association between the Internal Rotation Deficit and the appearance of a shoulder pain and/or discomfort when throwing
C- To assess the association between Internal Rotation Deficit and the appearance of a shoulder pathology demonstrated by clinical examination by at least one abnormality in one of the following three tests: the arming apprehension test, the relocation test or the O'Brien test
D- Assess changes in values of IRD 2, the ratio IRD 2/GRE 2, and the Total Range of Motion over the training season
E- Evaluate the association between the values of IRD 2 and the appearance of shoulder pain or discomfort when throwing
F- To evaluate the association between IRD 2 values and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
G- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of shoulder pain or discomfort when throwing
H- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
I- To estimate the optimal threshold value of the IRD 2/GRE 2 ratio that would define an Internal Rotation Deficit in a more relevant fashion as compred to the IRD 2 alone
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Professional players, men | – | –This group includes professional, male, handball players meeting study inclusion criteria. |
| Professional players, women | – | –This group includes professional, female, handball players meeting study inclusion criteria. |
| Junior players, men | – | –This group includes junior, male, handball players meeting study inclusion criteria. |
| Junior players, women | – | –This group includes junior, female, handball players meeting study inclusion criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is composed of all members of the professional and pre-professional handball clubs in the city of Nîmes, France (the USAM and HBCN clubs). Younger players who are members of the training centers associated with these same clubs will also be included.
Key inclusion criteria (3 listed)
- The subject or his/her legal guardian must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- The subject is a member of the professional and pre-professional handball clubs in Nîmes, France (the USAM or HBCN clubs) -- OR-- a member of the training centers associated with the same clubs whose parents or legal representatives have given informed consent
Key exclusion criteria (8 listed)
- The subject is under judicial protection, under tutorship or curatorship
- The subject or his/her legal respresentative refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject is pregnant, parturient, or breastfeeding
- The subject has been operated for shoulder instability, regardless of the surgical technique used
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
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time frame: 6 months
IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°
29 secondary outcomes
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time frame: baseline (Day 0)
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time frame: 3 months
Measure of the internal rotation deficit
Time frame: baseline (day 0)
Measure of the internal rotation deficit
Time frame: 3 months
Measure of the internal rotation deficit
Time frame: 6 months
The ratio of DRI 2 / GRE 2
Time frame: baseline (day 0)
The ratio of DRI 2 / GRE 2
Time frame: 3 months
The ratio of DRI 2 / GRE 2
Time frame: 6 months
Measure of the total range of motion
Time frame: baseline (day 0)
Measure of the total range of motion
Time frame: 3 months
Measure of the total range of motion
Time frame: 6 months
Presence/absence of pain when throwing (yes/no)
Time frame: baseline (day 0)
Presence/absence of pain when throwing (yes/no)
Time frame: 3 months
Presence/absence of pain when throwing (yes/no)
Time frame: 6 months
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time frame: baseline (day 0)
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time frame: 3 months
Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time frame: 6 months
Presence/absence of shoulder pathology
Time frame: baseline (day 0)
Presence/absence of shoulder pathology
Time frame: 3 months
Presence/absence of shoulder pathology
Time frame: 6 months
Shoulder clinical exam: the arming apprehension test
Time frame: baseline (day 0)
Shoulder clinical exam: the arming apprehension test
Time frame: 3 months
Shoulder clinical exam: the arming apprehension test
Time frame: 6 months
Shoulder clinical exam: relocation test
Time frame: baseline (day 0)
Shoulder clinical exam: relocation test
Time frame: 3 months
Shoulder clinical exam: relocation test
Time frame: 6 months
Shoulder clinical exam: the O'Brien test
Time frame: baseline (day 0)
Shoulder clinical exam: the O'Brien test
Time frame: 3 months
Shoulder clinical exam: the O'Brien test
Time frame: 6 months
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 26 Mar 2015.
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.
Olivier Marès, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Internal Rotation Contracture-shoulder and Articulation Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 8 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 26 Mar 2015. 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 France. 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?
Presence/absence of an internal rotation deficit (IRD 2 > 20°) (time frame: 6 months). 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 26 Mar 2015.