Effectiveness of Kinesiotaping in Primary Dysmenorrhea

NCT ID: NCT03290066

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-04-30

Brief Summary

Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

Detailed 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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kinesiotape

Kinesiotape 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 , ıt will start at the beginning of the menstruation.

Group Type: ACTIVE_COMPARATOR

kinesiotape

Intervention Type: DEVICE

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.

Usual care

Participants will use the usual self-care for primary dysmenorrhea. It will start at the beginning of the menstruation.

They will note the treatment indicating the dosage in a calendar.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Usual care

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

Intervention Type: OTHER

Other Intervention Names

self-care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Elena Estebanez de Miguel

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Estebanez de Miguel, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

Elena Estebanez de Miguel

Zaragoza, , Spain

Countries

Spain

Other Identifiers

UZaragoza

Identifier Type: -

Identifier Source: org_study_id