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Effectiveness of Kinesiotaping in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
kinesiotape
Usual care
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, Kinesio Taping

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Elena Estebanez de Miguel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Kinesiotape

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.'

Secondary Outcome Measures

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.'

Full Information

First Posted
September 12, 2017
Last Updated
July 30, 2019
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT03290066
Brief Title
Effectiveness of Kinesiotaping in Primary Dysmenorrhea
Official Title
Effectiveness of Kinesiotaping in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Primary Dysmenorrhea, Kinesio Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each woman will be assigned to a sequence of treatments, including two treatments (kinesiotape and usual dysmenorrhea treatment). The sample will be randomized in two different sequences of treatments (kinesiotape/usual treatment or usual treatment/kinesiotape)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
kinesiotape
Intervention Description
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
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
self-care
Intervention Description
Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).
Primary Outcome Measure Information:
Title
Change in menstrual pain with Visual Analogic Scale (VAS)
Description
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.'
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
Secondary Outcome Measure Information:
Title
Patient satisfaction with Visual Analogic Scale (VAS)
Description
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.'
Time Frame
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Estebanez de Miguel, PhD
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elena Estebanez de Miguel
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Kinesiotaping in Primary Dysmenorrhea

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