The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea

Study Overview
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Brief Summary
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To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

Detailed Description
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Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases. About 50-90% of the women experience menstrual pain, and approximately 15% of them suffer from a severe level of pain It is a common cause of absenteeism and reduced quality of life in women. From 21% to 96% of women with menstrual pain, reported to practice self-treatment either by pharmacological or nonpharmacological interventions. However, there are adverse events associated with the use of these drugs, including stomach ache, diarrhea, nausea, cutaneous reactions, liver or kidney damage or cardiovascular risk after discontinuing medication . Therefore, many patients with menstrual pain usually seek complementary and alternative techniques. Medical taping concept is an alternative treatment that use elastic adhesive tape, which is applied to the patient's skin under tension. It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.

Official Title
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The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Device: Medical taping
* Drug: Analgesic self-medication (OTC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women presenting menstrual pain, 4 or more in VAS. Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea Not have been diagnosed with secondary dysmenorrhea Regular menstrual cycles (cycle typical range of 21 to 35 days) Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills Nulliparous Ability to complete questionnaires in Spanish. Exclusion Criteria: Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10); Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days); Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills. Women who suffer from diseases diagnosed added Women to which it has undergone a surgical procedure for the treatment Provide skin lesions in the abdominal wall or in lumbar region Use or abuse of drugs or alcohol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Taping<br>Medical taping will be applied as a self-treatment. All participants will be instructed in an indvidual session and will receive a tutorial video to remember the kinesiotaping procedure. 3 band of a special and hypoallergenic tape (Kinematix Tex) will be attached to the abdominal (2 strips) and lower back (1 strip). Patients will be taped for four days. It will start at the beginning of pain associated to the menstruation. | Device: Medical taping<br>* For the medical taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back.<br>|
| Active Comparator: Analgesic self-medication (OTC)<br>Participants will use the usual analgesic self-treatment for primary dysmenorrhea.It will start at the beginning of pain associated to the menstruation. They will note the treatment indicating the analgesic and the dosage in a calendar. | Drug: Analgesic self-medication (OTC)<br>* Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in menstrual pain with Visual Analogic Scale (VAS) | VAS is a method of representing subjects' pain on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of pain' and 10 means 'a very high degree of pain | Participants will be followed for 6 menstrual cycles. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment in each menstrual cycle. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with Visual Analogic Scale (VAS) | Participants will note the self-care applied to relief menstrual pain indicating the VAS is a method of representing subjects' satisfaction with treatment on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of satisfaction with treatment' and 10 means 'a very high degree of satisfaction with treatment | Participants will be followed for 6 menstrual cycles. Evaluations will be performed at the end of each treatment, when menstrual pain disappears (4-5 days after the beginning of the menstrual bleeding). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Dysmenorrhea, Taping, Pain