Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/03/2014
Date assigned
11/04/2014
Last edited
20/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Overuse shoulder injuries and shoulder pain in general are common in overhead throwing sports, such as badminton, baseball, volleyball and handball. This study will use handball as a model to test the effects of a structured exercise program on the prevention of overuse shoulder injuries among elite players, building on recent studies about risk factors.

Who can participate?
All 48 male and female handball teams in the top two divisions in Norway will be invited to participate, giving a total number of about 800 players.

What does the study involve?
The teams will be randomly allocated to either the prevention (24 teams, 400 players) or control group (24 teams, 400 players). Players will be tested and asked to complete questionnaires before the 2014-2015 season, which starts in September and ends in April. During the season, teams in the prevention group are asked to complete a prevention program as part of their warm up. The control group is asked to continue normal training activity. During the season all players, in both groups, will be followed to record the prevalence of overuse shoulder injuries.

What are the possible benefits and risks of participating?
The knowledge gained will be of use to researchers, doctors and coaching staff working with overhead throwing athletes. This program have no side effects and there is no potential risk involved in participating in the study.

Where is the study run from?
The study is run from the Oslo Sports Trauma Research Center, Norway

When is the study starting and how long is it expected to run for?
This study starts in August 2014 and runs for 1 year

Who is funding the study?
Oslo Sports Trauma Research Center (Norway)

Who is the main contact?
Stig Haugsbø Andersson
s.h.andersson@nih.no

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stig Haugsboe Andersson

ORCID ID

Contact details

Norwegian School of Sport Sciences
Department of Sports Medicine
Oslo Sports Trauma Research Center
P.O. Box 4014 Ullevåll Stadion
Oslo
0806
Norway
+47 (0)900 675 819
s.h.andersson@nih.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A structured warm-up program to prevent overuse shoulder injuries among elite handball players: a cluster randomized controlled trial

Acronym

Study hypothesis

A structured warm-up program targeting scapular control, glenohumeral external rotation strength, glenohumeral internal rotation motion and core stability reduces the prevalence of overuse shoulder injuries among elite handball players.

Ethics approval

1. Regional Committees for Medical Research Ethics, 23/05/2014, case number: 2014/653/REK sør-øst
2. Norwegian Social Science and Data Service, 24/03/2014, case number: 28187/3/LT

Study design

Multi-team cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overuse shoulder injuries

Intervention

1. The prevention program will be implemented as a standard part of the warm up for handball training sessions in the intervention group throughout the 2014-2015 season. The prevention program will consist of exercises aimed at increasing scapular control, glenohumeral external rotation strength, glenohumeral internal range of motion and core stability.

2. The teams in the control group will continue to warm up and train as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Overuse shoulder injuries will be recorded biweekly in both groups during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire. All players will electronically receive the questionnaire consisting of four questions that record the extent to which each player may have reduced or modified their training, suffered from reduced performance, or experienced pain due to shoulder problems during the last seven days. In addition the questionnaire measures exposure to handball, both training and match, during the last seven days.

Secondary outcome measures

1. Injuries leading to time-loss, both acute and overuse, will be recorded in both groups monthly using an electronic questionnaire, which will be sent to the team physiotherapists.
2. Compliance with the prevention program will be recorded in the prevention group at every training session by the team coaches.
3. Additional strength training including the shoulder girdle will be measured monthly in both groups using an electronic questionnaire answered by the team coaches.

Overall trial start date

01/08/2014

Overall trial end date

15/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male and female handball players with a contract with either a Postenliga team (24 teams) or 1.divison team (24 teams) in the 2014-2015 season.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

There are no exclusion criteria

Recruitment start date

01/08/2014

Recruitment end date

15/08/2015

Locations

Countries of recruitment

Norway

Trial participating centre

Norwegian School of Sport Sciences
Oslo
0806
Norway

Sponsor information

Organisation

Oslo Sports Trauma Research Center (Norway)

Sponsor details

Department of Sports Medicine
Norwegian School of Sport Sciences
P.O. 4014 Ullevåll stadion
Oslo
0806
Norway
-
ostrc@nih.no

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Oslo Sports Trauma Research Center (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27313171

Publication citations

Additional files

Editorial Notes

20/06/2016: Publication reference added.