Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05111457 |
| Other study ID # |
2021-03382 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Linnaeus University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this project is to investigate the injury panorama of acute and overuse
injuries in women and men who regularly participate padel. The intention is to provide
insights on injury prevalence, injury location, injury consequences, gender differences and
risk factors .
This study will be conducted as a retrospective cohort study where the participants consist
of female and male padle players, both at the recreational and competition level, with at
least 6 months' experience in the sport. The information from this project can be valuable in
the work of identifying risk factors for padle injuries and injury prevention strategies.
Description:
Study design and participants This study will be conducted as an observational study using a
retrospective survey. The participants will consist of padle players at both recreational and
competitive level. An estimated 300 players will participate (~ 50% women). Recruitment will
take place through inquiries via padle associations, social media and information flyers
posted on padle courts around the Stockholm and Kalmar region. The survey will be aimed at
all regularly active women and men padle players, aged 18-65, with at least 6 months'
experience in the sport. Players with <1 hour of padle training per week will be excluded.
Procedure During the autumn of 2021, data collection will start for the retrospective part
and then continue for about 3 months. Injury registration will be carried out using a
web-designed registration form (SurveyMonkey®). The survey is designed with a previously
developed form for acute injuries and with the help of the online survey OSTRC Overuse Injury
Questionnaire for injuries of an overuse nature. The participant will register any
musculoskeletal injury and complaints that have occurred during the last 6 months. The
players will also provide information about age, gender, number of training hours per week
and experience of padle and other training routines.
Injury definition The injuries will be classified as either traumatic, i.e., the player could
define a specific sudden onset of pain with a defined trauma included, or as due to overuse.
The severity of the injury will be graded by the time of absence from training and match
participation. The injuries will be divided into three categories. ''Minor'' is defined as an
injury leading to an absence from training/matches of no more than 1 week. Injury leading to
an absence of 2-4 weeks is defined as ''moderate''. ''Major'' is defined as an injury leading
to an absence of more than 4 weeks.
Measurements The OSTRC survey was developed in Norway and has been translated and validated
into Swedish. The sensitivity of this survey is assumed to be much greater than traditional
questionnaires about injuries in sports and enables more overload injuries to be identified.
In addition, the survey registers the extent of injury prevention strategies as well as
training frequency, intensity, amount and type of training. The body regions that will be
registered are neck, shoulder, elbow, hand/wrist, thoracic spine, lumbar spine, hip, thighs,
knees and lower legs and foot/ankle. Participants will also estimate the severity of the
problems on ordinal scale ranging from 0-4, where "0" is referring to no problem, for each
body region. The acute injuries will be registered using previously developed forms for acute
injuries.
Statistics Statistics will be calculated using SPSS®25.0 (IBM SPSS Statistics, New York,
USA). Descriptive statistics (mean ± SD and range) will be calculated for each variable. To
compare means between the groups (women and men, age groups, recreational versus competitive
players), independent student T-tests will be used. Fisher's exact test will be used to
compare different injury location between groups. Pearson's correlation coefficient will be
used to assess associations between variables.To calculate if data is normally distributed,
in the retrospective part, a Shapiro-Wilks test of normality will be performed. The level of
significance will be set at p<0.05.
