- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829992
Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players
Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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São Paulo, São Paulo, Brazil, 04021-001
- Department of Gynecology of Federal University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Kinesio Taping group
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. |
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.
Other Names:
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Placebo Comparator: placebo 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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.
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At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)
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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)
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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
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At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)
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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)
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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".
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At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)
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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)
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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.
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At recruitment and at the end of the menstrual cycle of each of the four months of the study (each cycle is 28 days)
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Diary menstrual
Time Frame: Every day of the menstrual cycle throughout the four months of the study (each cycle is 28 days)
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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).
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Every day of the menstrual cycle throughout the four months of the study (each cycle is 28 days)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6665758
- 76907423.1.0000.5505 (Registry Identifier: 76907423.1.0000.5505)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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