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Injury PreventionHBSP-HU-25NCT07146243

Shoulder Injury Prevention in Adolescent Handball Players Based on Scandinavian Protocols

A study testing Norwegian OSTRC Shoulder Injury Prevention Programme in people with Injury Prevention and Shoulder Injuries, run by Semmelweis University at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This cluster-randomised controlled trial will evaluate the effects of two internationally recognised shoulder injury prevention programmes - the Swedish Shoulder Control programme and the Norwegian Oslo Sports Trauma Research Center Shoulder Injury Prevention programme - on shoulder function, scapular control, and… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Injury Prevention, Shoulder Injuries
What is being tested?
Norwegian OSTRC Shoulder Injury Prevention Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteHungary
Study dates
1 Aug 2025to 22 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Registered competitive handball players from the participating academy team (U16, U18, U20; male and female).
  • Age between 13 and 19 years at baseline assessment.
  • Currently participating in regular handball training and matches (minimum 3 training sessions per week).
  • Member of a team assigned to the intervention for the full study period.
  • Provided written informed consent (and parental consent for participants under 18 years).

Who cannot join

  • Acute shoulder injury at baseline preventing training
  • Shoulder surgery in last 6 months
  • Contraindication to resistance training
  • Concurrent enrolment in another interventional study targeting the shoulder/upper limb.
  • Refusal of informed consent (and parental consent for participants <18 years).

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Handball Academy

    Budapest

Other trials in Hungary

About this study

Official title: Shoulder Injury Prevention in Adolescent Handball Players Based on Scandinavian Protocols: A Cluster-Randomized Controlled Trial

This cluster-randomised controlled trial will evaluate the effects of two internationally recognised shoulder injury prevention programmes - the Swedish Shoulder Control programme and the Norwegian Oslo Sports Trauma Research Center Shoulder Injury Prevention programme - on shoulder function, scapular control, and injury incidence in Hungarian adolescent handball players (U16-U20). Six elite-level teams (3 male, 3 female) from a single handball academy will be randomised by cluster into two intervention arms for an 18-week intervention period. Primary outcomes are changes in objective shoulder function tests; secondary outcomes include self-reported function and weekly injury monitoring.

Read the detailed description

This study is a two-armed cluster-randomised controlled trial designed to assess the effects of two established, evidence-based shoulder injury prevention programmes in Hungarian adolescent elite handball players. Both programmes have previously demonstrated effectiveness in reducing the incidence of shoulder injuries in overhead athletes; however, it remains unclear how they compare in their ability to improve specific objective outcomes such as shoulder stability, proprioception, strength, and scapular control. The trial will be conducted at a single elite handball academy, including six teams (three male, three female) in the U16-U20 age categories. Teams will be randomised at the cluster level (team) into one of two intervention arms, each performing one of the two prevention programmes for the entire competitive half-season (18 weeks).

Unlike most injury prevention studies in adolescent athletes, this trial combines weekly self-reported monitoring of shoulder health (OSTRC-O Shoulder Module) with a comprehensive battery of objective, instrumented assessments of shoulder function, scapular control, strength, and proprioception. This dual approach allows for a more precise evaluation of programme effectiveness, capturing both perceived and measurable physical changes.

This prevention trial forms part of a larger, ongoing research programme investigating shoulder function and return-to-sport readiness following shoulder injury in overhead athletes. The same battery of objective tests (scapular dyskinesis assessment, LSST, mLSST, CKCUEST, YBT-UQ, proprioception testing, isometric strength testing) used here is also applied in the broader project, allowing the present study to generate insights that directly inform both preventive strategies and post-injury rehabilitation protocols.

The findings from this trial are expected to inform refinements of existing shoulder injury prevention protocols, enhance compliance strategies, and support sport-specific adaptations for adolescent elite handball players and other overhead athletes.

Being tested
Swedish Shoulder Control Programme, Norwegian OSTRC Shoulder Injury Prevention Programme
Keywords
overhead sport, handball, shoulder prevention, injury prevention
Medical subject headings
Shoulder Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swedish Shoulder Control ProgrammeBehavioural

    Also called Swedish Shoulder Control

    An evidence-based warm-up and strengthening routine developed for handball players to reduce the risk of shoulder injuries. The physiotherapy component includes exercises for scapular control, rotator cuff strength, and shoulder mobility. The throwing block is excluded in this trial, as it is designed for the off-season and the programme is implemented during the competitive season. Exercises are performed twice per week before training sessions, last about 15 minutes, and are supervised by two physiotherapists.

  • Norwegian OSTRC Shoulder Injury Prevention ProgrammeBehavioural

    Also called OSTRC Shoulder Injury Prevention Programme, Oslo Sports Trauma Research Centre Shoulder Programme

    An evidence-based warm-up and strengthening routine developed for handball players to reduce the risk of shoulder injuries. The programme focuses on exercises for scapular control, rotator cuff strength, and functional shoulder stability. Exercises are performed twice per week before training sessions, last about 15 minutes, and are supervised by two physiotherapists.

Study groups in NCT07146243
Study groupRoleWhat they receive
Swedish Shoulder Control ProgrammeExperimentalFemale U18, Male U16 and Male U20 perform the physiotherapy component of the Swedish Shoulder Control Programme, excluding the throwing block, as it is designed for the off-season and the programme is implemented during the competitive season. Sessions are supervised by two physiotherapists, performed twice per week for a total of 18 weeks, before training sessions, and last approximately 15 minutes each.
Receives: Behavioral: Swedish Shoulder Control Programme
Norwegian OSTRC Shoulder Injury Prevention ProgrammeExperimentalFemale U16, Female U20 and Male U18 perform the Norwegian Shoulder Injury Prevention Programme (OSTRC). This evidence-based programme includes warm-up and strengthening exercises targeting the shoulder complex, designed to reduce the risk of shoulder injuries. Sessions are supervised by two physiotherapists, performed twice per week for a total of 18 weeks, before training sessions, and last approximately 15 minutes each.
Receives: Behavioral: Norwegian OSTRC Shoulder Injury Prevention Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scapular Dyskinesis Test (SDT) - classification during flexion and abduction

    Description: Standard Kibler/McClure SDT with five consecutive repetitions of active shoulder flexion and abduction at a metronome cadence. Participants hold hand weights scaled to body mass: 1.5 kg if body mass <68.1 kg, and 2.5 kg if ≥68.1 kg. Testing is video-recorded. Two trained assessors, rate each shoulder from the videos as none / subtle / obvious dyskinesis for each plane. Primary outcome: proportion with any dyskinesis (subtle+obvious) by plane; secondary: shift in severity category from baseline. Lower prevalence/severity indicates improvement.

    Rater reliability plan: Inter-rater agreement will be quantified using weighted Cohen's kappa per plane.

    Measured: Baseline and 18 weeks

  2. Change in Y Balance Test - Upper Quarter (composite reach, % limb length)

    Description: YBT-UQ performed for each arm in three directions (medial, inferolateral, superolateral), three valid trials per direction. Composite reach score = (sum of the 3 maximal reaches / limb length) × 100. Limb length = C7 to tip of middle finger. Primary score is the composite % per arm; higher is better.

    Measured: Baseline and 18 weeks

  3. Shoulder proprioception error in external and internal rotation (absolute error, degrees)

    Joint position sense was assessed in supine position using a wrist-mounted digital angle gauge. For external rotation testing, the participant actively moved the arm to their individual full external rotation in 90° abduction. The target angle was then calculated using the formula:

    (Full ER in degrees-90)/2+90 This yields a mid-range position between neutral and the individual's maximal external rotation.

    First, with eyes open, then vision was occluded using a towel, and the procedure was repeated three times per limb: the assessor passively positioned the arm at the target, returned it to vertical, and the participant attempted to reposition it to the same angle without visual feedback.

    The absolute repositioning error (in degrees) between the target and reproduced positions was recorded for each trial, then averaged across the three trials per limb.

    Internal rotation target angle calculated as: 90-(90-Full IR in degrees)/2 Lower error values indicate better proprioceptive acuity

    Measured: Baseline and 18 weeks

  4. OSTRC-O Shoulder Module severity score (0-100)

    Weekly Oslo Sports Trauma Research Center Overuse Injury Questionnaire (4 items). Composite 0-100 severity (higher = worse). Report mean weekly severity, prevalence of any problem (non-minimum response on any item), and prevalence of substantial problem (moderate/severe reduction in training/performance or complete inability to participate), as per standard methodology.

    Measured: Weekly for 18 Weeks

Secondary outcomes (9)

  1. Change in CKCUEST performance (touch count)

    Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). Participants assume a standard push-up position with two parallel tape lines placed at a distance equal to 1.5 × the participant's biacromial breadth (measured between the lateral edges of the acromion processes). They alternately touch the opposite hand with one hand for three trials of 15 seconds each, with 30 seconds rest.

    Two outcomes are recorded:

    1. Touch count - mean number of valid touches across the three trials (per participant). Higher values indicate better upper-extremity closed-chain stability and power.
    2. Error count - number of form faults (e.g., loss of plank, hip rotation >45°, line misses) summed across the three trials. Lower values indicate better movement quality/control.

    A trained assessor records both outcomes according to published protocols, flagging invalid repetitions and documenting errors in real time.

    Measured: Baseline and 18 weeks

  2. Lateral Scapular Slide Test (LSST) total asymmetry score (3 positions)

    LSST performed by measuring the side-to-side difference (mm) in the distance between the inferior angle of the scapula (angulus inferior) and the nearest midline spinous process in three standardized arm positions: (1) arms relaxed at sides; (2) hands on hips with thumbs posterior; (3) 90° humeral abduction with internal rotation. The total LSST score is calculated as the sum of absolute asymmetries across the three positions. Lower scores indicate better scapular symmetry/control. Measurements are taken with a non-elastic, millimeter-scale measuring tape, with the athlete standing in a relaxed posture, feet shoulder-width apart.

    Measured: Baseline and 18 weeks

  3. Modified LSST (mLSST; 2 kg and 4 kg)

    Modified Lateral Scapular Slide Test (mLSST) performed in a static 30° scaption position while holding dumbbells of 2 kg and 4 kg, respectively. For each load, the side-to-side difference (mm) between the inferior angle of the scapula (angulus inferior) and the nearest midline spinous process is measured using a non-elastic, millimeter-scale measuring tape. The outcome for each load is the absolute asymmetry (mm). Lower values indicate better scapular symmetry/control under load.

    Measured: Baseline and 18 weeks

  4. Change in isometric shoulder strength - external and internal rotation

    Maximal isometric shoulder external rotation (ER) and internal rotation (IR) strength measured using a ForceFrame testing system (VALD Performance). Testing was performed in supine position with the shoulder in 90° abduction and neutral rotation. For each rotation direction, participants completed two maximal-effort trials per limb (due to time constraints; standard protocols recommend three), with ~30 seconds rest between trials.

    The highest peak force (N) from the two trials was used for analysis. Participants received standardized verbal encouragement during each trial. The ForceFrame system was calibrated before testing and measurements were recorded according to manufacturer guidelines.

    Measured: Baseline and 18 weeks

  5. Training/match exposure (minutes per week)

    Self-reported weekly minutes of handball training, match play, and strength/conditioning. Used to adjust analyses and to compute injury rates (exploratory).

    Measured: Weekly for 18 Weeks

  6. Programme adherence (sessions/week)

    Number of completed prevention sessions per week (team logs + player self-report). Outcome: mean sessions/week per athlete and per team; proportion achieving ≥2 sessions/week.

    Measured: Weekly for 18 Weeks

  7. Programme compliance (perceived usefulness score)

    Weekly self-reported perception of the programme's usefulness on a 0-10 scale (0 = not useful at all, 10 = extremely useful). Report mean weekly score and trends over time. Used to explore the relationship between perceived usefulness and adherence.

    Measured: Weekly for 18 Weeks

  8. Time-loss shoulder injury incidence (per 1,000 exposure hours) - exploratory

    Any acute or overuse shoulder complaint causing time-loss (missed full training/match), verified with staff logs. Rate = injuries / 1,000 h (training + match).

    Measured: Up to 18 Weeks

  9. Adverse events related to prevention sessions

    Number and nature of adverse events (e.g., exacerbation of pain leading to missed session; other exercise-related events) recorded by staff.

    Measured: Up to 18 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-armed Cluster-Randomised Controlled Trial
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146243
Sponsor's protocol ID
HBSP-HU-CRCT25
Acronym
HBSP-HU-25
Status last verified
Aug 2025
First submitted
13 Aug 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared. Data sharing is not planned in order to comply with data protection regulations and to safeguard participant confidentiality.

Publications

  • Asker M, Hagglund M, Walden M, Kallberg H, Skillgate E. The Effect of Shoulder and Knee Exercise Programmes on the Risk of Shoulder and Knee Injuries in Adolescent Elite Handball Players: A Three-Armed Cluster Randomised Controlled Trial. Sports Med Open. 2022 Jul 14;8(1):91. doi: 10.1186/s40798-022-00478-z.

    PubMed 35834139

  • Tooth C, Gofflot A, Schwartz C, Croisier JL, Beaudart C, Bruyere O, Forthomme B. Risk Factors of Overuse Shoulder Injuries in Overhead Athletes: A Systematic Review. Sports Health. 2020 Sep/Oct;12(5):478-487. doi: 10.1177/1941738120931764. Epub 2020 Aug 6.

    PubMed 32758080

  • Andersson SH, Bahr R, Clarsen B, Myklebust G. Preventing overuse shoulder injuries among throwing athletes: a cluster-randomised controlled trial in 660 elite handball players. Br J Sports Med. 2017 Jul;51(14):1073-1080. doi: 10.1136/bjsports-2016-096226. Epub 2016 Jun 16.

    PubMed 27313171

  • Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.

    PubMed 23038786

Questions about this trial

What is this clinical trial studying?

A study testing Norwegian OSTRC Shoulder Injury Prevention Programme in people with Injury Prevention and Shoulder Injuries, run by Semmelweis University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scapular Dyskinesis Test (SDT) - classification during flexion and abduction (time frame: Baseline and 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146243, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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