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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02011243
First received: December 9, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition
Internal Rotation Contracture-shoulder
Articulation Disorders
Athletic Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°


Secondary Outcome Measures:
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: baseline (Day 0) ] [ Designated as safety issue: No ]
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Measure of the internal rotation deficit [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Measure of the internal rotation deficit [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Measure of the internal rotation deficit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    GRE 2 = measure of the external gain in rotation in position 2 Position 2 = dominant arm in abduction at 90°

  • The ratio of DRI 2 / GRE 2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure of the total range of motion [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Measure of the total range of motion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Measure of the total range of motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Presence/absence of shoulder pathology [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Presence/absence of shoulder pathology [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Presence/absence of shoulder pathology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: relocation test [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: relocation test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: relocation test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: January 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011243

Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Olivier Marès, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02011243     History of Changes
Other Study ID Numbers: LOCAL/2013/OM-01, 2013-A01183-42
Study First Received: December 9, 2013
Last Updated: November 13, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
deficit
internal rotation
gleno humeral articulation
hand ball

Additional relevant MeSH terms:
Articulation Disorders
Athletic Injuries
Contracture
Communication Disorders
Joint Diseases
Language Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014