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Clinical Trials/NCT03290066
NCT03290066
Completed
Not Applicable

Effectiveness of Kinesiotaping in Primary Dysmenorrhea

Universidad de Zaragoza1 site in 1 country24 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Dysmenorrhea
Sponsor
Universidad de Zaragoza
Enrollment
24
Locations
1
Primary Endpoint
Change in menstrual pain with Visual Analogic Scale (VAS)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
April 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Estebanez de Miguel

PhD

Universidad de Zaragoza

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

Outcomes

Primary Outcomes

Change in menstrual pain with Visual Analogic Scale (VAS)

Time Frame: 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

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

  • Patient satisfaction with Visual Analogic Scale (VAS)(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).)

Study Sites (1)

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