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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04697615
Other study ID # FIS190098
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2020
Est. completion date March 16, 2020

Study information

Verified date January 2021
Source São Paulo State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 16, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria: - Healthy swimming athletes Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Algometry
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.

Locations

Country Name City State
Brazil University of Sao Paulo State Presidente Prudente São Paulo

Sponsors (1)

Lead Sponsor Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain threshold Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared). two hours
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