NCT01422083

Brief Summary

A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes this population interesting to investigate. This study wants to look at shoulders of overhead athletes with GIRD and measure the size of the subacromial space. After this, the athletes will be instructed to perform a home stretching program and at the end the effect of this on mobility and the size of the subacromial space will be measured.60 athletes will be recruited and randomly allocated to the control group and the stretching group. Before they start stretching, subacromial space size will be measured by use of ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a stretching exercise, which they will be performing at home once a day during 6 weeks. At the end all outcome measures will be reassessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4.6 years

First QC Date

August 22, 2011

Last Update Submit

November 18, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Size of the subacromial space and shoulder mobility.

    Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.

    at 0 weeks

  • Size of the subacromial space and shoulder mobility.

    Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.

    after 6 weeks

Study Arms (2)

Control group

NO INTERVENTION

This group of athletes do not perform a 6-week stretching program.

Home stretching program

EXPERIMENTAL

These athletes take on a home stretching program (sleeper's stretch).

Procedure: home stretching program

Interventions

A home stretching program (sleeper's stretch): 3 x 30 seconds, once a day for 6 weeks.

Home stretching program

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overhead athletes: at least 3 hours/week training
  • male and female
  • years of age
  • No shoulder pain during last 3 months for which a doctor was consulted
  • No shoulder surgery
  • No neck diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

  • Ann Cools, Ph.D.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations