Condition category
Musculoskeletal Diseases
Date applied
30/05/2018
Date assigned
05/06/2018
Last edited
05/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many handball players have shoulder pain while playing handball. A recent study demonstrated that it is possible to reduce the problem by over a quaarter. Despite this reduction in shoulder problems, only 3 in 10 of the coaches would continue using the whole program the next season, because 'the program was too time-consuming'. To be able to reduce the number of exercises and make the program more efficient, we need to know how the exercises reduce shoulder injuries. Shoulder external rotation weakness and limited internal rotation are considered to be the most important risk factors for shoulder problems in handball. The aim of our study is to test if the prevention program affects these two risk factors.

Who can participate?
Handball players aged 16 to 18 years from clubs located in or close to Oslo will be invited to participate in this study.

What does the study involve?
Half of the participants will do a shoulder prevention program designed for handball over an 18-week period, while the other half will do their regular handball warm-up and training. All the participants will be tested for shoulder strength and range of motion before, during the training period (after 6 and 12 weeks) and after the training period (18 weeks).

What are the possible benefits and risks of participating?
Reduction of shoulder problems is a possible benefit in the intervention group. (All the participants will be offered the training program after the intervention is finished). There are no known risks of participating.

Where is the study run from?
The study is being run by the Oslo Sports Trauma Research Center in Norway.

When is the study starting and how long is it expected to run for?
August/September 2018 to February 2018.

Who is funding the study?
Oslo Sports Trauma Research Center

Who is the main contact?
1. Hilde Fredriksen, hilde.fredriksen@nih.no
2. Grethe Myklebust, grethe.myklebust@nih.no

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Hilde Fredriksen

ORCID ID

Contact details

Norwegian School of Sport Sciences
Department of Sports Medicine
Oslo Sports Trauma Research Center
P.O.Box 4014 Ullevål Stadion
Oslo
0491
Norway
+4799709997
hilde.fredriksen@nih.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Investigating the effect of Oslo Sports Trauma Research Center (OSTRC) shoulder injury prevention program in handball on key risk factors, external rotation strength and internal rotational range of motion

Acronym

Study hypothesis

The OSTRC shoulder injury prevention program in handball affects the risk factorsfor shoulder injury: external rotation (ER) strength and internal rotation (IR) range of motion (ROM).

Ethics approval

Norwegian regional committee for medical and health research ethics, South East region, 14/05/2018, 2018/412/REK sør-øst

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Only available in Norwegian. Please use the contact details below to request a participant information sheet.

Condition

Shoulder injury prevention training in healthy handball players

Intervention

Four handball teams, players aged 16 to 18 years will participate. The teams will be randomized, with stratification for gender, to one exercise group and one control group.
The intervention group will perform the Oslo Sports Trauma Research Center (OSTRC) shoulder prevention program in handball over an 18-week period as described in the original study. The prevention program is a 10-minute warm-up program, carried out three times per week as a part of the regular handball warm-up, and consists of five exercises with different variations and levels. The exercises are intended to increase the muscle strength in shoulder external rotation (ER), to improve neuromuscular control around the scapula and improve shoulder internal rotation (IR) range of movement (ROM). Exercises to improve kinetic chain activation and thoracic mobility were also added.
The control group will continue doing their regular handball warm-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Shoulder isometric external rotation strength (measured with a handheld dynamometer [HHD]) after 18 weeks
2. Internal rotation range of motion after 18 weeks

Secondary outcome measures

1. Isometric ER strength by HHD at weeks 6 and 12
2. IR ROM at weeks 6 and 12
3. Isometric muscular strength by HHD in IR at weeks 6, 12 and 18
4. ER/IR isometric ratio at weeks 6, 12 and 18
5. Isokinetic ER and IR, concentric at 60 and 300°/sec and eccentric at 60°/sec, both absolute values and the functional deceleration ratio (FDR) ERecc/IRcon at 60°/sec at 18 weeks
6. IR at weeks 6, 12 and 18
7. Total rotational ROM at weeks 6, 12 and 18

Overall trial start date

01/01/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Handball players
2. Aged 16 to 18 years
3. Play handball in clubs located in or close to Oslo

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

52

Participant exclusion criteria

1. Player in a club that already implements the shoulder injury prevention program
2. Handball clubs with less than 12 players

Recruitment start date

01/08/2018

Recruitment end date

01/09/2018

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo Sports Trauma Research Center/ Norwegian School of Sport Science
Sognsveien 220
Oslo
0806
Norway

Sponsor information

Organisation

Oslo Sports Trauma Research Center

Sponsor details

P.O.Box 4014 Ullevål Stadion
Oslo
0806
Norway
+47 23262367
ostrc@nih.no

Sponsor type

Research organisation

Website

http://www.klokeavskade.no/en/

Funders

Funder type

Not defined

Funder name

Oslo Sports Trauma Research Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results in 2019-2020

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Hilde Fredriksen, hilde.fredriksen@nih.no. Raw data of strength and range of motion will be shared. The data will become available after publication of the study.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes