Musculoskeletal PainNCT04350242
Characteristics of Patients With Musculoskeletal Disorders
An observational study of Musculoskeletal Pain and Knee Injuries, run by Kine Kinesiologia Deportiva y Funcional at 1 site in Argentina.
Trial summary
Epidemiology, a word derived from the Greek epi (on) demos (people), is a scientific discipline in the area of medicine that studies the distribution, frequency and determining factors of chemical diseases in defined human populations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Pain, Knee Injuries
- How many people
- 1,539 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of private physiotherapy clinic
Who may be able to join
- All patients who attended a private physiotherapy center in the Autonomous City of Buenos Aires, between January 2017 and December 2019.
- Criteria Exclusion:
- Cases where the affected body region was not recorded were excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Patients With Musculoskeletal Disorders Who Attend a Private Physiotherapy Clinic in Argentina: a Retrospective Study
Epidemiology, a word derived from the Greek epi (on) demos (people), is a scientific discipline in the area of medicine that studies the distribution, frequency and determining factors of chemical diseases in defined human populations. It is the method of problem solving research used by epidemiologists, scientists, statisticians, doctors, and other health professionals to get to the root of health problems in a community. Beyond the important role of descriptive epidemiology in generating etiological hypotheses, it also provides a description of the frequency and / or patterns of disease occurrence at the individual or social level.
In the field of medicine and physiotherapy, epidemiological studies of musculoskeletal injuries acquire great relevance considering that they are the main cause of disability, increasing their prevalence year after year and carrying high economic and social costs. Worldwide, the Epidemiology of musculoskeletal pathologies has been reported in both the general population and specific populations.
Read more
Despite the fact that kinesiology has been an established profession in Argentina since the 1940s, there is an evident lack of scientific information on this discipline. Currently, epidemiological reports of published musculoskeletal pathologies are scarce in our country. To our knowledge, the characteristics of the population of patients with musculoskeletal injuries who attend a private sports kinesiology office are not known. A study of these characteristics could help to better understand this population, improving routine clinical practice, as well as providing a database for the development of future scientific studies.
For this reason, the main objective of this study is to describe the characteristics of the patients who come to an external kinesiology office at a private institution in Argentina. The secondary objective is to evaluate the relationship between the body mass index (BMI) and the affected body regions.
Read the detailed description
Design Variables related to injury Analytical, cross-sectional and retrospective study will be recorded. Population Those patients who attended a private physiotherapy center in the Autonomous City of Buenos Aires between January 2017 and December 2019 were consecutively included. Those cases in which the affected body region was not recorded were excluded.
Given the characteristics of the study, the signing of the informed consent by the patients was not required.
Process The information used for the analysis was collected during the first session in an evaluation form, prepared by kinesiologists belonging to the institution and used since January 2017. All the professionals who participated in the study had a prior period of theoretical training in the use of the file and the registration of the data. The information of each patient was collected by kinesiologists from this institution and posted on a Microsoft Excel® spreadsheet from which the corresponding analyzes were performed.
Sociodemographic variables The following variables will be recorded: sex, age, weight, height, body mass index (BMI), laterality, main sport, smoking, hours of rest and quality of self-perceived sleep (good, fair or poor).
The following variables: affected body region, type of injury, duration and form of onset of symptoms (acute without apparent reason, acute by specific event, gradual without apparent reason and gradual by specific event).
Statistic analysis Categorical variables are reported as presentation number and percentage. Continuous variables that assume a symmetric distribution are reported as mean ± standard deviation, while those with asymmetric distribution as median and interquartile range (RIC 25-75). A univariate analysis was used to search for the association between BMI and probability of injury. The R Markdown program was used for data analysis.
- Conditions
- Musculoskeletal Pain, Knee Injuries
- Medical subject headings
- Musculoskeletal Pain, Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of body region injured
Distribution of affected body region of the population
Measured: January 2018 - January 2020
Secondary outcomes (3)
Age
Mean age of population
Measured: January 2018 - January 2020
Sex
Female or male
Measured: January 2018 - January 2020
Body mass index
Calculation using a person's height and weight
Measured: January 2018 - January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kine Kinesiologia Deportiva y Funcional
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Diego Mendez, Kine Kinesiologia Deportiva y Funcional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350242
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Musculoskeletal Disorders Who Attend a Private Physiotherapy Clinic in Argentina: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04350242
- Acronym / sponsor ID
- 1
- Conditions
- Musculoskeletal Pain, Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- Kine Kinesiologia Deportiva y FuncionalResearch network
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 16 Apr 2020 (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.
Epidemiology, a word derived from the Greek epi (on) demos (people), is a scientific discipline in the area of medicine that studies the distribution, frequency and determining factors of chemical diseases in defined human populations. It is the method of problem solving research used by epidemiologists, scientists, statisticians, doctors, and other health professionals to get to the root of health problems in a community. Beyond the important role of descriptive epidemiology in generating etiological hypotheses, it also provides a description of the frequency and / or patterns of disease occurrence at the individual or social level.
In the field of medicine and physiotherapy, epidemiological studies of musculoskeletal injuries acquire great relevance considering that they are the main cause of disability, increasing their prevalence year after year and carrying high economic and social costs. Worldwide, the Epidemiology of musculoskeletal pathologies has been reported in both the general population and specific populations.
Despite the fact that kinesiology has been an established profession in Argentina since the 1940s, there is an evident lack of scientific information on this discipline. Currently, epidemiological reports of published musculoskeletal pathologies are scarce in our country. To our knowledge, the characteristics of the population of patients with musculoskeletal injuries who attend a private sports kinesiology office are not known. A study of these characteristics could help to better understand this population, improving routine clinical practice, as well as providing a database for the development of future scientific studies.
For this reason, the main objective of this study is to describe the characteristics of the patients who come to an external kinesiology office at a private institution in Argentina. The secondary objective is to evaluate the relationship between the body mass index (BMI) and the affected body regions.
Detailed description
Design Variables related to injury Analytical, cross-sectional and retrospective study will be recorded. Population Those patients who attended a private physiotherapy center in the Autonomous City of Buenos Aires between January 2017 and December 2019 were consecutively included. Those cases in which the affected body region was not recorded were excluded.
Given the characteristics of the study, the signing of the informed consent by the patients was not required.
Process The information used for the analysis was collected during the first session in an evaluation form, prepared by kinesiologists belonging to the institution and used since January 2017. All the professionals who participated in the study had a prior period of theoretical training in the use of the file and the registration of the data. The information of each patient was collected by kinesiologists from this institution and posted on a Microsoft Excel® spreadsheet from which the corresponding analyzes were performed.
Sociodemographic variables The following variables will be recorded: sex, age, weight, height, body mass index (BMI), laterality, main sport, smoking, hours of rest and quality of self-perceived sleep (good, fair or poor).
The following variables: affected body region, type of injury, duration and form of onset of symptoms (acute without apparent reason, acute by specific event, gradual without apparent reason and gradual by specific event).
Statistic analysis Categorical variables are reported as presentation number and percentage. Continuous variables that assume a symmetric distribution are reported as mean ± standard deviation, while those with asymmetric distribution as median and interquartile range (RIC 25-75). A univariate analysis was used to search for the association between BMI and probability of injury. The R Markdown program was used for data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of private physiotherapy clinic
Key inclusion criteria (3 listed)
- All patients who attended a private physiotherapy center in the Autonomous City of Buenos Aires, between January 2017 and December 2019.
- Cases where the affected body region was not recorded were excluded.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of body region injured
Time frame: January 2018 - January 2020
Distribution of affected body region of the population
3 secondary outcomes
Age
Time frame: January 2018 - January 2020
Sex
Time frame: January 2018 - January 2020
Body mass index
Time frame: January 2018 - January 2020
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 16 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Musculoskeletal Pain and Knee Injuries, run by Kine Kinesiologia Deportiva y Funcional at 1 site in Argentina.
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 0 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 16 Apr 2020. 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 Argentina. 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?
Rate of body region injured (time frame: January 2018 - January 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.