NCT06829992

Brief Summary

The objective of this clinical study is to investigate the effects of applying Kinesio Taping to female soccer players with PD and comparing this application with a placebo group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

February 11, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

primary dysmenorrheakinesio tapingfemale football

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Visual Analogue Scale (VAS): to assess the intensity of menstrual pain. 10 cm VAS, which proved to be a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 points (0 = no pain and 10 = maximum pain). Participants must mark the intensity of menstrual pain on the horizontal line, considering the most painful days of the menstrual cycle.

    At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days).

Secondary Outcomes (5)

  • Short McGill

    At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)

  • Menstrual complaints questionnaire

    At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)

  • Questionnaire on interference of Primary Dysmenorrhea in sports practice

    At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)

  • Short form health survey 36 (sf-36)

    At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)

  • Diary menstrual

    Every day of the menstrual cycle throughout the four months of the study (each cycle is 28 days)

Study Arms (2)

Kinesio Taping group

EXPERIMENTAL

KT will be applied by a physiotherapist with experience in the Kinesio Taping method by Kenzo Kase. Three I-shaped Kinesio tapes will be used, 5 cm wide, covering the T-11 and T-12 dermatomes. The first tape will be applied vertically between the navel and pubis, with the participant in an orthostatic position with slight trunk extension. The second tape, with the same length as the first, will be applied with its central region over the middle zone of the first, perpendicularly. The third tape will be applied horizontally to the lower back, covering the spines posterosuperior iliac muscles, with the participant in an orthostatic position, performing light trunk flexion.

Device: Kinesio Taping

placebo group

PLACEBO COMPARATOR

The quantity of tapes, type, size and region of application will be the same as the group KT, however, in this group the tapes will be applied without tension and with procedure different from that recommended, first starting to adhere a side anchor into the skin, followed by the center and then the other side anchor.

Device: Placebo Group

Interventions

KT will be applied by a physiotherapist with experience in the Kinesio Taping method by Kenzo Kase. Three I-shaped Kinesio tapes will be used, 5 cm wide, covering the T-11 and T-12 dermatomes. The first tape will be applied vertically between the navel and pubis, with the participant in an orthostatic position with slight trunk extension. The second tape, with the same length as the first, will be applied with its central region over the middle zone of the first, perpendicularly. The third tape will be applied horizontally to the lower back, covering the spines posterosuperior iliac muscles, with the participant in an orthostatic position, performing light trunk flexion.

Also known as: Taping, Tape
Kinesio Taping group

The quantity of tapes, type, size and region of application will be the same as the group KT, however, in this group the tapes will be applied without tension and with procedure different from that recommended, first starting to adhere a side anchor into the skin, followed by the center and then the other side anchor.

Also known as: placebo
placebo group

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Women practicing football from the Mulheres em Campo project
  • Primary dysmenorrhea
  • Aged between 15 and 17 years
  • Regular menstrual cycle (28 ± 7 days)
  • Nulliparous
  • Not having an intrauterine contraceptive device or using oral contraceptives
  • DP will be defined according to the Visual Analogue Scale from 5 points.

You may not qualify if:

  • Women who do not play football in the Mulheres em Campo project
  • Secondary dysmenorrhea
  • Diagnosed with serious comorbidity
  • Skin lesions in the abdominal region
  • Allergy to adhesive tapes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology of Federal University of São Paulo

São Paulo, São Paulo, 04021-001, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Kinesio Taping group and placebo group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

May 26, 2025

Primary Completion

September 27, 2025

Study Completion

November 18, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be authorized because the sample is made up of minors and the information collected is confidential. After the study is completed, the results will be duly published in accordance with ethical standards.

Locations