Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players

Athletic Injuries Clinical Trial

— GIRDH  

Official title:

Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011243
• Other study ID #: LOCAL/2013/OM-01
• Secondary ID: 2013-A01183-42
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: March 25, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Articulation Disorders
• Athletic Injuries
• Contracture
• Internal Rotation Contracture-shoulder

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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°	6 months	No
Secondary	Presence/absence of an internal rotation deficit (IRD 2 > 20°)		baseline (Day 0)	No
Secondary	Presence/absence of an internal rotation deficit (IRD 2 > 20°)		3 months	No
Secondary	Measure of the internal rotation deficit		baseline (day 0)	No
Secondary	Measure of the internal rotation deficit		3 months	No
Secondary	Measure of the internal rotation deficit		6 months	No
Secondary	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°	baseline (day 0)	No
Secondary	The ratio of DRI 2 / GRE 2		3 months	No
Secondary	The ratio of DRI 2 / GRE 2		6 months	No
Secondary	Measure of the total range of motion		baseline (day 0)	No
Secondary	Measure of the total range of motion		3 months	No
Secondary	Measure of the total range of motion		6 months	No
Secondary	Presence/absence of pain when throwing (yes/no)		baseline (day 0)	No
Secondary	Presence/absence of pain when throwing (yes/no)		3 months	No
Secondary	Presence/absence of pain when throwing (yes/no)		6 months	No
Secondary	Presence of discomfort when throwing (visual analog scale from 0 to 100)		baseline (day 0)	No
Secondary	Presence of discomfort when throwing (visual analog scale from 0 to 100)		3 months	No
Secondary	Presence of discomfort when throwing (visual analog scale from 0 to 100)		6 months	No
Secondary	Presence/absence of shoulder pathology		baseline (day 0)	No
Secondary	Presence/absence of shoulder pathology		3 months	No
Secondary	Presence/absence of shoulder pathology		6 months	No
Secondary	Shoulder clinical exam: the arming apprehension test		baseline (day 0)	No
Secondary	Shoulder clinical exam: the arming apprehension test		3 months	No
Secondary	Shoulder clinical exam: the arming apprehension test		6 months	No
Secondary	Shoulder clinical exam: relocation test		baseline (day 0)	No
Secondary	Shoulder clinical exam: relocation test		3 months	No
Secondary	Shoulder clinical exam: relocation test		6 months	No
Secondary	Shoulder clinical exam: the O'Brien test		baseline (day 0)	No
Secondary	Shoulder clinical exam: the O'Brien test		3 months	No
Secondary	Shoulder clinical exam: the O'Brien test		6 months	No