PrevalenceEPPPAFNCT05777096
Prevalence of Non-traumatic Musculoskeletal Disorders in the French Paragliding Pilots Population
An observational study of Prevalence and Musculoskeletal Disorders, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to determine the prevalence of non-traumatic pathologies in the paragliding population using the Nordic type questionnaire. The paragliding pilots population frequently evoque pathologies, discomfort, or pain in the course of their practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevalence, Musculoskeletal Disorders
- What is being tested?
- Standardised Nordic questionnaires
- How many people
- 2,475 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2023to 4 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 26000 people will be surveyed via the internet link. In 2021, according to the federal statistics of the FFVL accessible on the intranet of the FFVL, the number of practicing paraglider with a license was about 26000.
Who may be able to join
- over 18 years old
- Registered with the FFVL for the year 2022 and/or 2023
- Paragliding in the year 2022 and/or 2023
Who cannot join
- Adults not able to express their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble Alpes University - Faculty of Medecine - Departement of Physiotherapy
Saint-Martin-d'Hères, 38400
About this study
The main objective is to determine the prevalence of non-traumatic pathologies in the paragliding population using the Nordic type questionnaire.
The paragliding pilots population frequently evoque pathologies, discomfort, or pain in the course of their practice. Said pain and discomfort, though unerelated any form of accident, seem to have an impact on the pilots' flying and their participation in daily life.
However, no epidemiological data are available in the literature. Investigators hypothesize the existence of non-traumatic disorders and it seems interesting to quantify the extent of the phenomenon. The results of this study might encourage the proposition of preventive measures in order to minimize a potential risk factor for paragliding accidents, and participation restrictions.
Read the detailed description
In this cross-sectional descriptive epidemiological survey, investigators wish to quantify epidemiological parameters such as the prevalence of pathologies and their consequences in the activities of daily life.
For this purpose, an email containing the link to answer the online questionnaire will be sent to all the licensees.
The link of the questionnaire will be sent directly to all clubs in each league.
The main objective is to calculate the prevalence with descriptive statistics. The primary outcome is the prevalence of non-traumatic pathology in paragliding pilots that had registered to the French Paragliding federation (FFVL) in 2022.
The prevalence will be infered from the IRSST Standardised Nordic Questionnaire with the following formula : Prevalence = (FS4+FS6=yes and FS2=no ) divided by the total number of respondents.
FS4 item "Yes" = pain in the last 12 months FS6 item "Yes" = activity limitations) FS2 item "No" = Non-traumatic disorders
This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having suffered trauma in the area.
For the secondary outcomes will aim at exploring several hypotheses related to personal and environmental factors that could be correlated to the incidence of the nontraumatic disorders. They will be calculated with bivariate descriptive statistics using the Pvalue.io software.
- Conditions
- Prevalence, Musculoskeletal Disorders
- Being tested
- Standardised Nordic questionnaires
- Keywords
- paragliding, musculoskeletal Diseases, non-traumatic pathology, Standardised Nordic Questionnaire, overuse injury
- Medical subject headings
- Musculoskeletal Diseases, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised Nordic questionnairesDiagnostic test
participants will complete the SNQ online. Estimated time of participation per person: 15 minutes to fill in the questionnaires
| Study group | Role | What they receive |
|---|---|---|
| registered | Paragliding pilots over the age of 18. Registered at the "Fédération Française de Vol Libre" (FFVL) in the year 2022 and/or 2023 Paragliding in the year 2022 and/or 2023 Receives: Diagnostic Test: Standardised Nordic questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of non-traumatic pathologies in the paragliding pilot population
The prevalence will be calculated using the IRSST's Standardised Nordic Questionnaire.
Prevalence = (FS4+FS6=yes and FS2=no ) on total number of respondents. This prevalence will be calculated on the Population Health, with the FS4 and FS6 items. And to be more specific about atraumatic pathologies, it is necessary to have answered "no" to the FS2 item. This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having undergone trauma in the area concerned.
Measured: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Secondary outcomes (3)
Correlations between prevalence, a body area, restriction of participation in paragliding and individual characteristics of participants
Correlation analysis (univariate and bivariate) between responses to different questions to test for a potential association between variables
Measured: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Paragliders' beliefs about the origin of their pain.
Number of respondents with musculoskeletal disorder (FS9=yes)/total number of positive cases ((FS4+FS6=yes and FS2=no)
Measured: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Prevalence of injuries sustained during a paragliding accident
Number of respondents with musculoskeletal disorder due to accident/total number of pain positive cases and participation restriction ((FS4+FS6=yes and FS2.3=yes)
Measured: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start12 Mar 2023
- Primary completion4 Jun 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrevalenceStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 2,475 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas LATHIERE, Principal investigator, Département de kinésithérapie, 175 avenue centrale 38400 Saint Martin d'Hères
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777096
- Sponsor's protocol ID
- 2023-A00131-44
- Acronym
- EPPPAF
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
PubMed 15676628desLibris, L'enquête québécoise sur la santé de la population 2008, Canadian Electronic Library. Canada. Retrieved from https://canadacommons.ca/artifacts/1238967/lenquete-quebecoise-sur-la-sante-de-la-population-2008/1792039/ on 05 Mar 2023. CID: 20.500.12592/rvf74g.
Alexis Descatha, Yves Roquelaure, Agnès Aublet-Cuvelier, Catherine Ha, Annie Touranchet, et al.. Validité du questionnaire de type "Nordique" dans la surveillance des pathologies d'hypersollicitation du membre supérieur. Documents pour le Médecin du Travail, 2007, pp.509-517. ffinserm-00232629
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-traumatic Musculoskeletal Disorders in the French Paragliding Pilots Population
- ClinicalTrials.gov ID
- NCT05777096
- Acronym / sponsor ID
- EPPPAF / 2023-A00131-44
- Conditions
- Prevalence, Musculoskeletal Disorders
- Keywords
- paragliding, musculoskeletal Diseases, non-traumatic pathology, Standardised Nordic Questionnaire, overuse injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,475 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to determine the prevalence of non-traumatic pathologies in the paragliding population using the Nordic type questionnaire.
The paragliding pilots population frequently evoque pathologies, discomfort, or pain in the course of their practice. Said pain and discomfort, though unerelated any form of accident, seem to have an impact on the pilots' flying and their participation in daily life.
However, no epidemiological data are available in the literature. Investigators hypothesize the existence of non-traumatic disorders and it seems interesting to quantify the extent of the phenomenon. The results of this study might encourage the proposition of preventive measures in order to minimize a potential risk factor for paragliding accidents, and participation restrictions.
Detailed description
In this cross-sectional descriptive epidemiological survey, investigators wish to quantify epidemiological parameters such as the prevalence of pathologies and their consequences in the activities of daily life.
For this purpose, an email containing the link to answer the online questionnaire will be sent to all the licensees.
The link of the questionnaire will be sent directly to all clubs in each league.
The main objective is to calculate the prevalence with descriptive statistics. The primary outcome is the prevalence of non-traumatic pathology in paragliding pilots that had registered to the French Paragliding federation (FFVL) in 2022.
The prevalence will be infered from the IRSST Standardised Nordic Questionnaire with the following formula : Prevalence = (FS4+FS6=yes and FS2=no ) divided by the total number of respondents.
FS4 item "Yes" = pain in the last 12 months FS6 item "Yes" = activity limitations) FS2 item "No" = Non-traumatic disorders
This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having suffered trauma in the area.
For the secondary outcomes will aim at exploring several hypotheses related to personal and environmental factors that could be correlated to the incidence of the nontraumatic disorders. They will be calculated with bivariate descriptive statistics using the Pvalue.io software.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| registered | – | Diagnostic Test: Standardised Nordic questionnairesParagliding pilots over the age of 18. Registered at the "Fédération Française de Vol Libre" (FFVL) in the year 2022 and/or 2023 Paragliding in the year 2022 and/or 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 26000 people will be surveyed via the internet link. In 2021, according to the federal statistics of the FFVL accessible on the intranet of the FFVL, the number of practicing paraglider with a license was about 26000.
Key inclusion criteria (3 listed)
- over 18 years old
- Registered with the FFVL for the year 2022 and/or 2023
- Paragliding in the year 2022 and/or 2023
Key exclusion criteria (1 listed)
- Adults not able to express their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised Nordic questionnairesparticipants will complete the SNQ online. Estimated time of participation per person: 15 minutes to fill in the questionnaires | Diagnostic test | registered |
Primary outcome
Prevalence of non-traumatic pathologies in the paragliding pilot population
Time frame: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
The prevalence will be calculated using the IRSST's Standardised Nordic Questionnaire. Prevalence = (FS4+FS6=yes and FS2=no ) on total number of respondents. This prevalence will be calculated on the Population Health, with the FS4 and FS6 items. And to be more specific about atraumatic pathologies, it is necessary to have answered "no" to the FS2 item. This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having undergone trauma in the area concerned.
3 secondary outcomes
Correlations between prevalence, a body area, restriction of participation in paragliding and individual characteristics of participants
Time frame: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Paragliders' beliefs about the origin of their pain.
Time frame: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Prevalence of injuries sustained during a paragliding accident
Time frame: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 15676628Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
- BackgrounddesLibris, L'enquête québécoise sur la santé de la population 2008, Canadian Electronic Library. Canada. Retrieved from https://canadacommons.ca/artifacts/1238967/lenquete-quebecoise-sur-la-sante-de-la-population-2008/1792039/ on 05 Mar 2023. CID: 20.500.12592/rvf74g.
- BackgroundAlexis Descatha, Yves Roquelaure, Agnès Aublet-Cuvelier, Catherine Ha, Annie Touranchet, et al.. Validité du questionnaire de type "Nordique" dans la surveillance des pathologies d'hypersollicitation du membre supérieur. Documents pour le Médecin du Travail, 2007, pp.509-517. ffinserm-00232629
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas LATHIERE principal investigator
Département de kinésithérapie, 175 avenue centrale 38400 Saint Martin d'Hères
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence and Musculoskeletal Disorders, run by University Hospital, Grenoble at 1 site in France.
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 3 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 7 Mar 2024. 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 France. 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?
Prevalence of non-traumatic pathologies in the paragliding pilot population (time frame: Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)). 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 NCT05777096, which also lists 3 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 7 Mar 2024.