Prevention of overuse shoulder injury in handball
| ISRCTN | ISRCTN99023492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99023492 |
| Secondary identifying numbers | 2019-02 |
- Submission date
- 15/01/2020
- Registration date
- 06/02/2020
- Last edited
- 25/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Josef-Schneider-Straße 2
Wuerzburg
97080
Germany
 ORCID ID |
0000-0002-9053-0624 |
|---|---|
| Phone | +49 941 9446805 |
| leonard@dr-achenbach.eu |
Study information
| Study design | Prospective cluster-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (in German) |
| Scientific title | Prevention of overuse shoulder injury in handball: a cluster-randomised controlled trial |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/07/2019 |
| Overall study end date | 30/04/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 players |
| Total final enrolment | 579 |
| 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 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
Study participating centres
Franz-Josef-Strauss Allee 11
Regensburg
93053
Germany
Josef-Schneider-Straße 2
Wuerzburg
87080
Germany
Sponsor information
Hospital/treatment centre
Federal Institute for Sports Sciences
Franz-Josef-Strauss Allee 11
Regensburg
93053
Germany
| Phone | +49 941 9446805 |
|---|---|
| Peter.Stehle@bisp.de | |
| Website | http://www.uniklinikum-regensburg.de/e/ |
"ROR" |
https://ror.org/01226dv09 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- German Federal Institute of Sport Science, BISp
- Location
- Germany
Results and Publications
| Intention to publish date | 30/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/03/2022 | 25/03/2022 | Yes | No |
Editorial Notes
25/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
05/02/2020: Trial’s existence confirmed by Universität Regensburg.
