Condition category
Musculoskeletal Diseases
Date applied
15/01/2020
Date assigned
06/02/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Handball is associated with a high risk of overuse shoulder injury in the throwing shoulder that needs to be reduced. The purpose of this study is to show how an injury-prevention programme effectively reduces overuse shoulder injury in adult handball players.

Who can participate?
Any active handball player aged 18 years or older in any of the German-speaking handball leagues with at least one competitive match during the interventional season 2019-20

What does the study involve?
Teams register for the study and are allocated randomly in either the intervention arm or control arm. Players of the intervention group regularly participate in an injury-prevention programme for one season. Handball exposure and sustained injuries are documented for both groups on a biweekly basis.

What are the possible benefits and risks of participating?
Possible benefits of the intervention arm are the complete reduction or reduction in intensity of overuse shoulder injury symptoms in the throwing arm. No risk are reported to date for neuromuscular injury prevention programmes.

Where is the study run from?
1. Department of Trauma Surgery, University Medical Center Regensburg, Germany
2. Dpt. of Trauma, Hand, Plastic and Reconstructive Surgery, University Medical Center Wuerzburg, Germany

When is the study starting and how long is it expected to run for?
May 2019 to April 2020

Who is funding the study?
Bundesinstitut für Sportwissenschaft / German Federal Institute for Sports Sciences

Who is the main contact?
Dr Leonard Achenbach
leonard@dr-achenbach.eu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leonard Achenbach

ORCID ID

http://orcid.org/0000-0002-9053-0624

Contact details

Josef-Schneider-Straße 2
Wuerzburg
97080
Germany
+49 941 9446805
leonard@dr-achenbach.eu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-02

Study information

Scientific title

Prevention of overuse shoulder injury in handball: a cluster-randomised controlled trial

Acronym

Study hypothesis

The purpose of this study is to show how an injury prevention programme specific for shoulder effectively reduces overuse throwing shoulder injury in handball players.

Ethics approval

Approved 16.05.2019, Ethics Committee of the University of Regensburg (Universität Regensburg, ETHIKKOMMISSION, 93049 Regensburg, Germany; +49 941 943 5370; ethikkommission@klinik.uni-regensburg.de), ref: ID 17-894_1-101

Study design

Prospective cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Overuse throwing shoulder injury

Intervention

Intervention arm: teams are given a neuromuscular training programme. this should be implemented at least twice per week during the whole course of the season

Control arm: teams proceed with their normal training without any instructions

Total duration: season 2019/20 (July 2019 - April 2020)

Both arms have a follow-up during the season every two weeks by means of a standardised injury questionnaire, until the end of the study (April 2020)

Due to the low number of expected teams, stratified cluster randomisation is carried out and a 1:1 randomisation in both arms is scheduled. Stratification is based on sex (male/female), age (under-19/senior) and level of professionalism (league 1-3 / 4-6 / 7 or lower).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Prevalence and intensity of overuse throwing shoulder injury measured using the OSTRC (Oslo Trauma Research Center) Overuse questionnaire as well as short handball-specific WOSI (Western Ontario Shoulder Index) every two weeks throughout the study.

Secondary outcome measures

Measured using the OSTRC (Oslo Trauma Research Center) Overuse questionnaire as well as short handball-specific WOSI (Western Ontario Shoulder Index) every two weeks throughout the study:
1. Prevalence and intensity of severe overuse throwing shoulder injury
2. Prevalence and intensity of overuse elbow injury

Overall trial start date

01/07/2019

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Active handball player in any of the German-speaking handball leagues with at least one competitive match during the interventional season 2019-20
2. Male or female
3. Willingness to implement biweekly prevention exercises into training and match warm-up

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

600 players

Participant exclusion criteria

1. Inability to understand written German
2. No signed consent

Recruitment start date

01/05/2019

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Center Regensburg
Department of Trauma Surgery Franz-Josef-Strauss Allee 11
Regensburg
93053
Germany

Trial participating centre

University Medical Center Wuerzburg
Dpt. of Trauma, Hand, Plastic and Reconstructive Surgery Josef-Schneider-Straße 2
Wuerzburg
87080
Germany

Sponsor information

Organisation

University Hospital Regensburg

Sponsor details

Federal Institute for Sports Sciences
Franz-Josef-Strauss Allee 11
Regensburg
93053
Germany
+49 941 9446805
Peter.Stehle@bisp.de

Sponsor type

Hospital/treatment centre

Website

http://www.uniklinikum-regensburg.de/e/

Funders

Funder type

Government

Funder name

Bundesinstitut für Sportwissenschaft

Alternative name(s)

German Federal Institute of Sport Science, BISp

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Germany

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

30/04/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: Trial’s existence confirmed by Universität Regensburg.