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Sports InjuryNCT05909592

Epidemiological Analysis of Shoulder Injuries Among Greek CrossFit Participants and Predictive Modeling for Shoulder Injury Incidence.

An observational study of Sports Injury and Shoulder Injuries, run by University of Patras at 1 site in Greece.

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

CrossFit is a modern sport, introduced to the public in 2000 and popular quickly with more than 15,000 affiliates worldwide. Due to the highly demanding nature of the workouts, it is claimed to be a sport with a high prevalence of injuries. Read more about this study

Who is it for?
Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for
Sports Injury, Shoulder Injuries, Risk Factors
How many people
111 participants
Where
1 siteGreece
Study dates
24 Sep 2022to 12 Feb 2024
How long will I take part?
1 Year
Phase
Observational
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 18 to 62 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 150 (anticipated) healthy individuals who participate in CrossFit. They are training in Crossfit affiliated boxes located at 4 different towns in Greece.

Who may be able to join

  • Healthy adults CrossFit participants of any level of experience
  • Novices who have already completed the trial workouts

Who cannot join

  • Injured CrossFit participants who have not yet returned to ordinary training

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • University of Patras

    Patras, Peloponnese, 26504

Other trials in Greece

About this study

Official title: Epidemiological Profile and Shoulder Injury Risk Factors Investigation Among CrossFit Participants. Predictive Modeling for Shoulder Injury Incidence in These Populations.

CrossFit is a modern sport, introduced to the public in 2000 and popular quickly with more than 15,000 affiliates worldwide. Due to the highly demanding nature of the workouts, it is claimed to be a sport with a high prevalence of injuries. Most preliminary retrospective studies had shown that shoulder area is injured most frequently, at about a quarter of all injuries. Therefore, the initial goal of this observational (prospective cohort) study is to learn about the incidence rates of shoulder injuries and potential risk factors in a Greek population of CrossFit participants. Based on these results, this study's ultimate purpose is to create a short warm-up program capable of reducing shoulder injuries and evaluate its effectiveness.

The main questions it aims to answer are:

Read more
  • Are shoulder injuries as frequent as previous studies have shown to be?
  • Can we blame for these injuries a previous history of musculoskeletal injury or deficits of range of motion, strength, and muscular endurance?
  • Can a short warm up which targets revealed deficiencies be effective in reducing shoulder injuries incidence rates?

Participants will be asked to:

  • take part in baseline measurements (personal data, previous musculoskeletal history, shoulder and core range of motion, shoulder and hip muscle strength, shoulder stabilizers endurance, functional assessment sport-specific tests)
  • be monitored for new shoulder injuries or aggravation of old shoulder injuries that will occur during 12 months following baseline measurements. In this case, they must refer it to their coaches to be contacted and assessed by the researcher.
  • be in touch with the researcher throughout the observational study and provide any required data regarding their participation
Read the detailed description

CrossFit is prescribed as "a constantly varied, high-intensity, functional movement". It is a highly motivational way of training including a wide variety of different exercises modalities, including calisthenics, gymnastics, metabolic conditioning, and weightlifting, which includes both Olympic and powerlifting movements. This training model has been demonstrated to improve 10 physical skills: cardiovascular and respiratory endurance, stamina, strength, flexibility, power, speed, coordination, agility, balance, and accuracy. Its popularity has increased in recent years with more than 200,000 athletes competing worldwide and many more participants of a lower level. These characteristics led to concerns about CrossFit's safety, accordingly many researchers began to investigate whether the injury incidence rates are higher than other sports with retrospective studies, which were conducted via online questionnaires. The purpose of this prospective cohort study is to investigate shoulder injury rate among CrossFit participants in Greece and to design and examine the efficacy of a sport-specific injury prevention program in these kinds of injuries.

One hundred and eleven CrossFit participants will be surveyed. After reading and signing informed consent form, they will be interviewed for personal data, previous injuries history and general health. Shoulders and core range of motion, shoulders and hips muscle strength, shoulder stabilizers endurance will be measured with valid and reliable instruments. Also, functional assessment will be carry out using a novel instrument which has been developed in previous stage via a pilot study. CrossFit Screening Tool had been designed as a functional assessment instrument and applied as a pilot study to 20 CrossFit athletes. Based on the results, we have selected the functional tasks which will implement the baseline measurements process.

The sample will be monitored for any shoulder injury by the researcher for the following 12 months. In the term of shoulder injury is included any new or aggravated old injury which costs the athlete's absence or urges performance modifications for tissue protection. When an injury occurs, the researcher will contact the athlete, assess him using special questionnaires and clinical examination, including valid and reliable special clinical tests. She will document the kind of injury and give him or her rehabilitation and return-to-sport guidelines.

Baseline data of the participants who experienced injury will be correlated with the corresponding data of those who did not, using specific statistical analysis methods to disclose the aetiologic parameters. According to the results, at the next stage, a predictive model for shoulder injury incidence will be created using machine learning. The researchers of the present study aim to generate a model which be able to prognosticate the athletes who are going to be injured in whichever shoulder presenting high accuracy and low overfitting.

Keywords
Sports Injury, Shoulder Injuries, Risk Factors, Injury Prevention, Injury Prediction, Machine Learning, CrossFit
Medical subject headings
Athletic Injuries, Shoulder Injuries

What participants receive

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

Study groups in NCT05909592
Study groupRoleWhat they receive
Healthy CrossFit participants and athletesNo intervention. The group will be monitored for incidence data of shoulder injuries (new or aggravated pre-existing)

What is being measured

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

  1. BMI

    Weight (kg) and Height (cm) data will be collected to report BMI in kg/m^2

    Measured: Baseline assessment

  2. Demographic, general history and shoulder injuries history, activity and experience level

    Participant profile will be formed using an especially designed questionnaire, data will be collected regarding the age, upper limb dominance, months of experience, training volume in hours per week, level of competition, warm up and recovery routines adequacy, details of previous injuries and current situation of shoulder functionality.

    Measured: Baseline assessment

  3. Core rotation active range of motion

    Right and left core rotation will be measured in degrees utilizing a digital goniometer (HALO digital goniometer, HALO Medical Devices) which has affixed on an aluminum stick. Participant will be holding the stick by hands at the level of scapulas spines and starting rotate his or her core to right and then left direction.

    Measured: Baseline assessment

  4. Shoulder active range of motion symmetries

    Comparative measurements among shoulders. In an upright position, knees forward and flexed as far as it will be needed in order back and lower back to be attached on the wall, participant will move his/her shoulders toward flexion while maintaining the initial position on the wall. When movement will reach the end point of the available range of motion, the researcher will measure the distances between each wrist and the wall using a measuring tape. The distance may be symmetrical otherwise the shoulder of the upper limb with the bigger distance will be documented as deficient.

    Same procedure in the same body position will be followed for external and internal rotation of the shoulders but movements will be performed with 90 degrees of shoulder abduction and 90 degrees of elbow flexion.

    Measured: Baseline assessment

  5. Shoulder stabilizers muscle strength

    Maximal strength of each shoulder external and internal rotators will be measured in kilograms of resistance utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Measured: Baseline assessment

  6. Lateral differences in muscle strength between shoulders

    The percentage of lateral differences in maximal strength of internal and external rotation between shoulders will be measured utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Measured: Baseline assessment

  7. Hip abductors muscle strength

    Maximal strength of each hip abductors muscles will be measured in kilograms of resistance with the use of a handheld digital dynamometer, K-Force Muscle Controller, via K-Force application reporting (Kinvent, Montpellier, France)

    Measured: Baseline assessment

  8. Lateral differences in hip abductors strength

    The percentage of lateral differences in maximal strength of abduction between hips will be measured utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Measured: Baseline assessment

  9. Muscular endurance of shoulder external rotators

    Using the aforementioned dynamometer application, participants will be asked to do 3 sets of 30 seconds isometric hold at the 60% of the maximal previously produced strength by external rotators muscles (outcome 5). 5 seconds rest between sets will be used. The percentage of the time, on which participants can produce the requested amount of power, will be recorded. This measurement will reflect the endurance capability of this muscle group for each shoulder. Measurement data will be collected using a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France).

    Measured: Baseline assessment

  10. Lateral differences in shoulder external rotators endurance

    The percentage of lateral differences in external rotation isometric hold between right and left side will be exported from K-Force Pro application reporting.

    Measured: Baseline assessment

  11. Shoulder stability

    Closed Kinetic Chain Upper Extremity Stability test (CKCUES) will be performed to evaluate shoulder stability.

    Measured: Baseline assessment

  12. CrossFit-specific functional parameters (flexibility, stability, power) using an innovative evaluation tool: CrossFit Functional Assessment Battery for Shoulder (CrossFit FABS)

    Flexibility, stability and power will be evaluated using an innovative assessment tool which was developed especially for the purpose of the present research. CrossFit FABS (Functional Assessment Battery for Shoulder) is a CrossFit-specific, functional evaluation battery in regard to shoulder injury risks. It is composed of 6 tests which resulted from a wider tool through applied pilot research: deep air squat, shoulder mobility, upper frontal kinetic chain flexibility, overhead squat facing wall, windmill with kettlebell and sots press. Each test is scored from 0 to 3, using a 3-point scoring scale with a maximum total score of 18 points.

    Measured: Baseline assessment

  13. Shoulder injury incidents

    Any new or aggravated pre-existing shoulder injury that will be responsible for at least 1-day training or game loss or training modification to avoid specific high-impact exercises will be recorded. Also, the whole progression of the recovery until return-to-sport will be monitored.

    Measured: Up to 12 months

  14. Shoulder injury characteristics

    Injury profile will be formed using an especially designed objective and subjective assessment questionnaire, including present injury history, correlation with performed exercise, symptoms, observation abnormalities and special diagnostic tests for shoulder pain (clinical assessment). Exact kind of injury will be determined by the researcher.

    Measured: Up to 12 months

  15. Disability of injured participants

    A self-reported questionnaire for shoulder, the SDQ (Shoulder Disability Questionnaire), will be filled by injured participants via interview method by the researcher.

    Measured: Up to 12 months

  16. Pain intensity of injured participants

    VAS pain scale will be used to determine shoulder pain intensity in injured participants.

    Measured: Up to 12 months

Secondary outcomes (2)
  1. Shoulder injury risk factors

    Analyzing data of the injured and non-injured participants will reveal possible risk factors for shoulder injuries.

    Measured: After study completion, 2nd year

  2. Predictive modeling for shoulder injury incidence in CrossFit

    Using machine learning it is aimed to develop a predictive model able to identify the athletes who are going to be injured in their shoulder, ensuring high accuracy and low overfitting.

    Measured: After study completion, 2nd year

Timeline

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

  1. First posted18 Jun 2023
  2. Study start24 Sep 2022
  3. Primary completion12 Feb 2023
  4. Study completion12 Feb 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
111 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05909592
Sponsor's protocol ID
14279
Status last verified
Jan 2025
First submitted
1 May 2023
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bullock GS, Mylott J, Hughes T, Nicholson KF, Riley RD, Collins GS. Just How Confident Can We Be in Predicting Sports Injuries? A Systematic Review of the Methodological Conduct and Performance of Existing Musculoskeletal Injury Prediction Models in Sport. Sports Med. 2022 Oct;52(10):2469-2482. doi: 10.1007/s40279-022-01698-9. Epub 2022 Jun 11.

    PubMed 35689749
  • Schwank A, Blazey P, Asker M, Moller M, Hagglund M, Gard S, Skazalski C, Haugsbo Andersson S, Horsley I, Whiteley R, Cools AM, Bizzini M, Ardern CL. 2022 Bern Consensus Statement on Shoulder Injury Prevention, Rehabilitation, and Return to Sport for Athletes at All Participation Levels. J Orthop Sports Phys Ther. 2022 Jan;52(1):11-28. doi: 10.2519/jospt.2022.10952.

    PubMed 34972489
  • Asker M, Brooke HL, Walden M, Tranaeus U, Johansson F, Skillgate E, Holm LW. Risk factors for, and prevention of, shoulder injuries in overhead sports: a systematic review with best-evidence synthesis. Br J Sports Med. 2018 Oct;52(20):1312-1319. doi: 10.1136/bjsports-2017-098254. Epub 2018 Mar 26.

    PubMed 29581141
  • Angel Rodriguez M, Garcia-Calleja P, Terrados N, Crespo I, Del Valle M, Olmedillas H. Injury in CrossFit(R): A Systematic Review of Epidemiology and Risk Factors. Phys Sportsmed. 2022 Feb;50(1):3-10. doi: 10.1080/00913847.2020.1864675. Epub 2021 Jan 7.

    PubMed 33322981
  • Silva ER, Maffulli N, Migliorini F, Santos GM, de Menezes FS, Okubo R. Function, strength, and muscle activation of the shoulder complex in Crossfit practitioners with and without pain: a cross-sectional observational study. J Orthop Surg Res. 2022 Jan 15;17(1):24. doi: 10.1186/s13018-022-02915-x.

    PubMed 35033136
  • Torres-Banduc MA, Jerez-Mayorga D, Moran J, Keogh JWL, Ramirez-Campillo R. Isokinetic force-power profile of the shoulder joint in males participating in CrossFit training and competing at different levels. PeerJ. 2021 Sep 17;9:e11643. doi: 10.7717/peerj.11643. eCollection 2021.

    PubMed 34616590
  • Montalvo AM, Shaefer H, Rodriguez B, Li T, Epnere K, Myer GD. Retrospective Injury Epidemiology and Risk Factors for Injury in CrossFit. J Sports Sci Med. 2017 Mar 1;16(1):53-59. eCollection 2017 Mar.

    PubMed 28344451

Questions about this trial

What is this clinical trial studying?

An observational study of Sports Injury and Shoulder Injuries, run by University of Patras at 1 site in Greece.

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 2 inclusion and 1 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 5 Feb 2025. 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 Greece. 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?

BMI (time frame: Baseline assessment). The study lists 16 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 NCT05909592, which also lists 7 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 5 Feb 2025.

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