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Completed

NCT Number: NCT04164823

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

To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

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Key information

Conditions

Primary Dysmenorrhea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elena Estébanez de Miguel

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical taping

Device

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.

Analgesic self-medication (OTC)

Drug

Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).

Primary outcomes

  1. Change in menstrual pain with Visual Analogic Scale (VAS)

    Time frame: 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.

    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

Secondary outcomes

  1. Patient satisfaction with Visual Analogic Scale (VAS)

    Time frame: 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).

    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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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