<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290066</url>
  </required_header>
  <id_info>
    <org_study_id>UZaragoza</org_study_id>
    <nct_id>NCT03290066</nct_id>
  </id_info>
  <brief_title>Effectiveness of Kinesiotaping in Primary Dysmenorrhea</brief_title>
  <official_title>Effectiveness of Kinesiotaping in Primary Dysmenorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before&#xD;
      or during menstruation, in the absence of other diseases.&#xD;
&#xD;
      Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common&#xD;
      cause of absenteeism and reduced quality of life in women.&#xD;
&#xD;
      Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the&#xD;
      physiological mechanisms behind menstrual pain (such as prostaglandin production) or by&#xD;
      relieving symptoms.&#xD;
&#xD;
      First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal&#xD;
      anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some&#xD;
      women have contraindications to these treatments. Consequently, it´s necessary to study&#xD;
      alternative treatments to drug treatments. Alternative treatments like heat, massage therapy,&#xD;
      acupuncture also are used.&#xD;
&#xD;
      The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the&#xD;
      1970s. It is water resistant and retains its properties up to 5 days.&#xD;
&#xD;
      It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure&#xD;
      on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive&#xD;
      stimuli.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_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)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in menstrual pain with Visual Analogic Scale (VAS)</measure>
    <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</time_frame>
    <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.'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with Visual Analogic Scale (VAS)</measure>
    <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).</time_frame>
    <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.'</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Kinesiotape</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).&#xD;
Patients will be taped for four days , ıt will start at the beginning of the menstruation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will use the usual self-care for primary dysmenorrhea. It will start at the beginning of the menstruation.&#xD;
They will note the treatment indicating the dosage in a calendar.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>kinesiotape</intervention_name>
    <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.</description>
    <arm_group_label>Kinesiotape</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).</description>
    <arm_group_label>Usual care</arm_group_label>
    <other_name>self-care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women presenting menstrual pain, 4 or more in VAS.&#xD;
&#xD;
          -  Have attended gynecological examination in the past 18 months and had ever diagnosed&#xD;
             as having a gynecological disorder different from primary dysmenorrhea&#xD;
&#xD;
          -  Not have been diagnosed with secondary dysmenorrhea&#xD;
&#xD;
          -  Regular menstrual cycles (cycle typical range of 21 to 35 days)&#xD;
&#xD;
          -  Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive&#xD;
             pills&#xD;
&#xD;
          -  Nulliparous&#xD;
&#xD;
          -  Ability to complete questionnaires in Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);&#xD;
&#xD;
          -  Women with irregular or infrequent menstrual cycles (outside the typical range of&#xD;
             cycle 21 to 35 days);&#xD;
&#xD;
          -  Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive&#xD;
             pills.&#xD;
&#xD;
          -  Women who suffer from diseases diagnosed added&#xD;
&#xD;
          -  Women to which it has undergone a surgical procedure for the treatment&#xD;
&#xD;
          -  Provide skin lesions in the abdominal wall or in lumbar region&#xD;
&#xD;
          -  Use or abuse of drugs or alcohol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Estebanez de Miguel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Zaragoza</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elena Estebanez de Miguel</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Elena Estebanez de Miguel</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Primary Dysmenorrhea</keyword>
  <keyword>Kinesio Taping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290066
org study id: UZaragoza
nct id: NCT03290066
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention 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)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 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
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.'
measure: Patient satisfaction with Visual Analogic Scale (VAS)
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).
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.'
arm group label: Kinesiotape
arm group type: Active Comparator
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 group label: Usual care
arm group type: Active Comparator
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: kinesiotape
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.
arm group label: Kinesiotape
intervention type: Other
intervention name: Usual care
description: Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).
arm group label: Usual care
other name: self-care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Elena Estebanez de Miguel, PhD
role: Principal Investigator
affiliation: Universidad de Zaragoza
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Elena Estebanez de Miguel
investigator title: PhD
mesh term: Dysmenorrhea