NCT04697615

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 4, 2021

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain threshold

    Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).

    two hours

Study Arms (1)

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.

Device: Algometry

Interventions

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.

Algometry

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Healthy swimming athletes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo State

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

January 3, 2020

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Individual data will not be released, because participants are under eighteen.

Locations