NCT07146243

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

January 6, 2026

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 13, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

overhead sporthandballshoulder preventioninjury prevention

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline and 18 weeks

  • 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.

    Baseline and 18 weeks

  • 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

    Baseline and 18 weeks

  • 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.

    Weekly for 18 Weeks

Secondary Outcomes (9)

  • Change in CKCUEST performance (touch count)

    Baseline and 18 weeks

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

    Baseline and 18 weeks

  • Modified LSST (mLSST; 2 kg and 4 kg)

    Baseline and 18 weeks

  • Change in isometric shoulder strength - external and internal rotation

    Baseline and 18 weeks

  • Training/match exposure (minutes per week)

    Weekly for 18 Weeks

  • +4 more secondary outcomes

Study Arms (2)

Swedish Shoulder Control Programme

EXPERIMENTAL

Female 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.

Behavioral: Swedish Shoulder Control Programme

Norwegian OSTRC Shoulder Injury Prevention Programme

EXPERIMENTAL

Female 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.

Behavioral: Norwegian OSTRC Shoulder Injury Prevention Programme

Interventions

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.

Also known as: Swedish Shoulder Control
Swedish Shoulder Control 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.

Also known as: OSTRC Shoulder Injury Prevention Programme, Oslo Sports Trauma Research Centre Shoulder Programme
Norwegian OSTRC Shoulder Injury Prevention Programme

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Handball Academy

Budapest, Hungary

Location

Related Publications (4)

  • 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.

    PMID: 35834139BACKGROUND
  • 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.

    PMID: 32758080BACKGROUND
  • 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.

    PMID: 27313171BACKGROUND
  • 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.

    PMID: 23038786BACKGROUND

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Attila Pavlik, MD, PhD

    Department of Sports Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the team-based cluster randomization and the nature of the intervention, masking of participants, coaches, and outcome assessors is not feasible. Entire teams are assigned to either the Swedish or the Norwegian shoulder injury prevention programme, making the intervention easily identifiable. The physiotherapists conducting the physical performance tests are aware of team allocation because they are also involved in the organization and supervision of the intervention sessions. However, the primary outcomes are objective, performance-based measures (e.g., CKCUEST, Y Balance Test-Upper Quarter, LSST, SDT, shoulder proprioception testing), which substantially reduces the potential risk of measurement bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-armed Cluster-Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 28, 2025

Study Start

August 1, 2025

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

January 6, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations