Primary Dysmenorrhea (PD)NCT06829992
Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players
A study testing Kinesio Taping in people with Primary Dysmenorrhea (PD), run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Kinesio Taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 26 May 2025to 18 Nov 2025
- Phase
- Interventional
- 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 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Gynecology of Federal University of São Paulo
São Paulo, São Paulo, 04021-001
About this study
Official title: Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players: Randomized Clinical Trial
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.
Read the detailed description
Women's football has grown in the last decade, but there is still a need to study how the menstrual cycle affects players' performance. Primary Dysmenorrhea (PD), a common menstrual pain, impacts between 50% and 90% of women, reducing their participation in sporting activities. Many players notice that their performance is affected during the cycle, and the use of anti-inflammatories is not always effective. Therefore, it is important to implement simple measures that improve the quality of life and performance of players. Alternatives such as physical therapy and Kinesio Taping (KT) can help alleviate symptoms. The literature shows that KT is a technique with the potential to produce tactile sensory impulses on the skin, which can block or reduce the arrival of painful sensations to the brain, and could therefore be interesting in the treatment of PD. Therefore, the present study aims to investigate the effects of applying Kinesio Taping to female soccer players with PD and comparing this application with a placebo group.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Kinesio Taping, Placebo Group
- Keywords
- primary dysmenorrhea, kinesio taping, female football
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingDevice
Also called Taping, Tape
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.
Placebo GroupDevice
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessment of subjective pain in relation to PD. Shortened version of the original McGill questionnaire, translated and validated into Portuguese. The person assessed must choose one of 15 words and the pain is classified according to its sensory and affective dimensions, along with an analogue scale that assesses the general intensity of the pain in the last few days and a 6-item scale with a global description of the intensity. The questionnaire score is calculated based on the intensity of the pain descriptors chosen by the patient. Being the intensity scale 0 = none, 1 = mild, 2 = uncomfortable, 3 = distressing, 4 = horrible, 5 = excruciating. The pain index is obtained by adding the intensity values of the chosen descriptors. The highest possible value is 20, as the patient can only choose one word per subgroup. The higher the total score, the greater the patient's pain experience.
Measured: 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
Assessment of the presence of low back pain, headache, abdominal swelling, breast tenderness, fatigue, nausea, vomiting, diarrhea, constipation, insomnia, nervousness and depression. Responses will be recorded as "present" or "absent" on a questionnaire
Measured: 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
Assessment of how much the symptoms of primary dysmenorrhea interfered with their sports practice. The responses will be recorded as "almost no interference", "little interference", "medium interference", "a lot of interference", "intense interference".
Measured: 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)
Assessment of quality of life. Translated and validated version into Portuguese of the Short Form Health Survey 36. The SF-36 assesses eight aspects of quality of life: Functional capacity, Physical aspects, Emotional aspects, Pain, General health status, Vitality, Social aspects, Mental health. Your score ranges from 0 to 100, with 0 being the worst health status and 100 being the best.
Measured: 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
Paper diary where they must record with a pen every time they take medication due to discomfort related to dysmenorrhea in each menstrual cycle, as well as the intensity of the discomfort (mild, moderate, intense).
Measured: Every day of the menstrual cycle throughout the four months of the study (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start26 May 2025
- Primary completion27 Sep 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Kinesio Taping group and placebo group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maíta Poli de Araújo, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829992
- Sponsor's protocol ID
- 6665758
- Other IDs
- 76907423.1.0000.5505
- Status last verified
- Nov 2025
- First submitted
- 11 Feb 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06829992
- Acronym / sponsor ID
- 6665758
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- primary dysmenorrhea, kinesio taping, female football
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 17 Feb 2025 (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.
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.
Detailed description
Women's football has grown in the last decade, but there is still a need to study how the menstrual cycle affects players' performance. Primary Dysmenorrhea (PD), a common menstrual pain, impacts between 50% and 90% of women, reducing their participation in sporting activities. Many players notice that their performance is affected during the cycle, and the use of anti-inflammatories is not always effective. Therefore, it is important to implement simple measures that improve the quality of life and performance of players. Alternatives such as physical therapy and Kinesio Taping (KT) can help alleviate symptoms. The literature shows that KT is a technique with the potential to produce tactile sensory impulses on the skin, which can block or reduce the arrival of painful sensations to the brain, and could therefore be interesting in the treatment of PD. Therefore, the present study aims to investigate the effects of applying Kinesio Taping to female soccer players with PD and comparing this application with a placebo group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Kinesio Taping group and placebo group.
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping group | Experimental | Device: Kinesio TapingKT 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. |
| placebo group | Placebo comparator | Device: Placebo GroupThe 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. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Women practicing football from the Mulheres em Campo project
- Primary dysmenorrhea
- Aged between 15 and 17 years
- Regular menstrual cycle (28 ± 7 days)
- Nulliparous
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Kinesio TapingAlso: Taping, TapeKT 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 group |
| Placebo GroupAlso: placeboThe 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 |
Primary outcome
Visual Analogue Scale
Time frame: At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days).
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.
5 secondary outcomes
Short McGill
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Every day of the menstrual cycle throughout the four months of the study (each cycle is 28 days)
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 24 Nov 2025.
- Individual participant dataSharing planned: No. 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.
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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?
A study testing Kinesio Taping in people with Primary Dysmenorrhea (PD), run by Federal University of São Paulo 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 7 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 24 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days).). 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 24 Nov 2025.