Clinical trial NCT02011243: Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players
Official title: Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internal Rotation Contracture-shoulder
Articulation Disorders
Athletic Injuries
Keywords: deficit
internal rotation
gleno humeral articulation
hand ball
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence/absence of an internal rotation deficit (IRD 2 > 20°)
timeFrame: 6 months
Secondary outcomes:
measure: Presence/absence of an internal rotation deficit (IRD 2 > 20°)
timeFrame: baseline (Day 0)
measure: Presence/absence of an internal rotation deficit (IRD 2 > 20°)
timeFrame: 3 months
measure: Measure of the internal rotation deficit
timeFrame: baseline (day 0)
measure: Measure of the internal rotation deficit
timeFrame: 3 months
measure: Measure of the internal rotation deficit
timeFrame: 6 months
measure: The ratio of DRI 2 / GRE 2
timeFrame: baseline (day 0)
measure: The ratio of DRI 2 / GRE 2
timeFrame: 3 months
measure: The ratio of DRI 2 / GRE 2
timeFrame: 6 months
measure: Measure of the total range of motion
timeFrame: baseline (day 0)
measure: Measure of the total range of motion
timeFrame: 3 months
measure: Measure of the total range of motion
timeFrame: 6 months
measure: Presence/absence of pain when throwing (yes/no)
timeFrame: baseline (day 0)
measure: Presence/absence of pain when throwing (yes/no)
timeFrame: 3 months
measure: Presence/absence of pain when throwing (yes/no)
timeFrame: 6 months
measure: Presence of discomfort when throwing (visual analog scale from 0 to 100)
timeFrame: baseline (day 0)
measure: Presence of discomfort when throwing (visual analog scale from 0 to 100)
timeFrame: 3 months
measure: Presence of discomfort when throwing (visual analog scale from 0 to 100)
timeFrame: 6 months
measure: Presence/absence of shoulder pathology
timeFrame: baseline (day 0)
measure: Presence/absence of shoulder pathology
timeFrame: 3 months
measure: Presence/absence of shoulder pathology
timeFrame: 6 months
measure: Shoulder clinical exam: the arming apprehension test
timeFrame: baseline (day 0)
measure: Shoulder clinical exam: the arming apprehension test
timeFrame: 3 months
measure: Shoulder clinical exam: the arming apprehension test
timeFrame: 6 months
measure: Shoulder clinical exam: relocation test
timeFrame: baseline (day 0)
measure: Shoulder clinical exam: relocation test
timeFrame: 3 months
measure: Shoulder clinical exam: relocation test
timeFrame: 6 months
measure: Shoulder clinical exam: the O'Brien test
timeFrame: baseline (day 0)
measure: Shoulder clinical exam: the O'Brien test
timeFrame: 3 months
measure: Shoulder clinical exam: the O'Brien test
timeFrame: 6 months
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Olivier Marès, MD
role: PRINCIPAL_INVESTIGATOR
References: