Effectiveness of Kinesiotaping in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effectiveness of Kinesiotaping in Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290066
• Other study ID #: UZaragoza
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2019
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

Description:

Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.

Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common cause of absenteeism and reduced quality of life in women.

Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms.

First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some women have contraindications to these treatments. Consequently, it´s necessary to study alternative treatments to drug treatments. Alternative treatments like heat, massage therapy, acupuncture also are used.

The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s. It is water resistant and retains its properties up to 5 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• kinesiotape
For the Kinesio 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.

Other:
• Usual care
Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).

Locations

Country	Name	City	State
Spain	Elena Estebanez de Miguel	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 2 menstrual cycles, an expected average of 3 months. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment
Secondary	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 2 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).