AthletesNCT04697615
Reliability of Algometry in Swimming Athletes
An observational study of Athletes, run by São Paulo State University at 1 site in Brazil.
Trial summary
In the competitive swimming scenario, there is a significant incidence of pain, which can be justified by the high levels of training that exposes athletes to constant stress. In this way, the quantification of pain and its monitoring becomes extremely important for clinical practice. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Algometry
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jan 2020to 16 Mar 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.
Who may be able to join
- Healthy swimming athletes
Who cannot join
- Being an alcoholic and/or consuming drugs and/or smoking;
- Anti-inflammatory and / or analgesic drugs less than 24 hours before the test;
- Presenting anemia, inflammatory process, diabetes, cardiovascular disease;
- Episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months;
- In addition to swimming for less than two years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo State
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Reliability of Algometry as a Clinical Value in Swimming Athletes
In the competitive swimming scenario, there is a significant incidence of pain, which can be justified by the high levels of training that exposes athletes to constant stress. In this way, the quantification of pain and its monitoring becomes extremely important for clinical practice. A commonly used tool with easy access and clinical applicability, capable of measuring the pain threshold (PT) in a standardized manner is the pressure algometer. However, there is a shortage in the literature of studies that evaluate the reliability of this instrument in healthy swimming athletes. Objectives: Evaluate the intra and inter-examiner reliability and to describe the profile of the PT measurements measured by the algometer in swimming athletes. Methods: It is a reliability study, and will be composed of fifty young athletes members of swimming teams, of both genders, aged between 12 and 20 years. The evaluation will be carried out on the same day and in 2 steps: (1) Test and (2) Retest. In the first step, through a third examiner, the participants will be subjected to marking of points in pre-determined muscles and in points of referred pain. Next, they will perform the PT assessment through the algometer by two other distinct and trained examiners. The interval between each examiner will be five minutes with the participant at rest. After five minutes the test was performed, the step retest will begin, which will have the same procedures as in the previous step. The statistical package SPSS Statistics 23.0 will be used to conduct the analyzes.
- Conditions
- Athletes
- Being tested
- Algometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometryDevice
The evaluation with the algometer was carried out in the same way by the two examiners, who held the instrument with the dominant hand, in order to adjust and coordinate the movements, while the non-dominant hand was used to stabilize the participant's skin, providing more security, avoiding thus small deviations. The pressure was applied at an angle of 90 ° (between the tool surface and the evaluated point), the rate of pressure increase was approximately 2 kg / cm² / s (kilogram per centimeter squared per second), up to the level that the participant reported a change in the sensation of pressure to a sensation of discomfort and immediately the examiner removed the device from the positioned location.
| Study group | Role | What they receive |
|---|---|---|
| Algometry | In the test stage, pain threshold evaluations were started through the algometer in a randomized manner by two different examiners trained and experienced in the application of the test, following the same order of evaluation of the muscles (middle deltoid, upper trapezius, pectoralis major, biceps brachii , triceps, lumbar multifidus, rectus femoris, biceps femoris, tibialis anterior and soleus, bilaterally), with an interval between each assessment of five minutes in which the participants remained at rest. After the interval described, the retest stage was initiated, which had the same procedures as the test stage. Receives: Device: Algometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold
Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Jan 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697615
- Sponsor's protocol ID
- FIS190098
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be released, because participants are under eighteen.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Algometry as a Clinical Value in Swimming Athletes
- ClinicalTrials.gov ID
- NCT04697615
- Acronym / sponsor ID
- FIS190098
- Conditions
- Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 6 Jan 2021 (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.
In the competitive swimming scenario, there is a significant incidence of pain, which can be justified by the high levels of training that exposes athletes to constant stress. In this way, the quantification of pain and its monitoring becomes extremely important for clinical practice. A commonly used tool with easy access and clinical applicability, capable of measuring the pain threshold (PT) in a standardized manner is the pressure algometer. However, there is a shortage in the literature of studies that evaluate the reliability of this instrument in healthy swimming athletes. Objectives: Evaluate the intra and inter-examiner reliability and to describe the profile of the PT measurements measured by the algometer in swimming athletes. Methods: It is a reliability study, and will be composed of fifty young athletes members of swimming teams, of both genders, aged between 12 and 20 years. The evaluation will be carried out on the same day and in 2 steps: (1) Test and (2) Retest. In the first step, through a third examiner, the participants will be subjected to marking of points in pre-determined muscles and in points of referred pain. Next, they will perform the PT assessment through the algometer by two other distinct and trained examiners. The interval between each examiner will be five minutes with the participant at rest. After five minutes the test was performed, the step retest will begin, which will have the same procedures as in the previous step. The statistical package SPSS Statistics 23.0 will be used to conduct the analyzes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algometry | – | Device: AlgometryIn the test stage, pain threshold evaluations were started through the algometer in a randomized manner by two different examiners trained and experienced in the application of the test, following the same order of evaluation of the muscles (middle deltoid, upper trapezius, pectoralis major, biceps brachii , triceps, lumbar multifidus, rectus femoris, biceps femoris, tibialis anterior and soleus, bilaterally), with an interval between each assessment of five minutes in which the participants remained at rest. After the interval described, the retest stage was initiated, which had the same procedures as the test stage. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.
Key inclusion criteria (1 listed)
- Healthy swimming athletes
Key exclusion criteria (5 listed)
- Being an alcoholic and/or consuming drugs and/or smoking;
- Anti-inflammatory and / or analgesic drugs less than 24 hours before the test;
- Presenting anemia, inflammatory process, diabetes, cardiovascular disease;
- Episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months;
- In addition to swimming for less than two years.
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 |
|---|---|---|
| AlgometryThe evaluation with the algometer was carried out in the same way by the two examiners, who held the instrument with the dominant hand, in order to adjust and coordinate the movements, while the non-dominant hand was used to stabilize the participant's skin, providing more security, avoiding thus small deviations. The pressure was applied at an angle of 90 ° (between the tool surface and the evaluated point), the rate of pressure increase was approximately 2 kg / cm² / s (kilogram per centimeter squared per second), up to the level that the participant reported a change in the sensation of pressure to a sensation of discomfort and immediately the examiner removed the device from the positioned location. | Device | Algometry |
Primary outcome
Pain threshold
Time frame: two hours
Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).
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 12 Jan 2021.
- Individual participant dataSharing planned: No. Individual data will not be released, because participants are under eighteen.
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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 Athletes, run by São Paulo State University at 1 site in Brazil.
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 1 inclusion and 5 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 12 Jan 2021. 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 Brazil. 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?
Pain threshold (time frame: two hours). 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 12 Jan 2021.