<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/NCT04400968</url>
  </required_header>
  <id_info>
    <org_study_id>58/2017</org_study_id>
    <nct_id>NCT04400968</nct_id>
  </id_info>
  <brief_title>Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.</brief_title>
  <official_title>A Randomised Clinical Trial of the Effects of Kinesiotaping vs.Auricular Therapy in Women With Primary Dysmenorrhoea.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Extremadura</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>
      This study analyse the effectiveness of auricular therapy vs. kinesio tape treatment for pain&#xD;
      management of women with primary dysmenorrhoea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pharmacological treatments are not effective for all women and therefore, the objective of&#xD;
      this study was to assess and compare the effectiveness of kinesio tape and auricular therapy&#xD;
      to decrease pain and drug intake in women with primary dysmenorrhoea.&#xD;
&#xD;
      A randomized controlled trial was conducted. 114 university women from 18 to 30 years old&#xD;
      were randomized to 5 groups: control, kinesio tape, placebo kinesio tape, auricular therapy&#xD;
      and placebo auricular therapy. The study was carried out during 4 menstrual cycles of&#xD;
      pre-treatment phase, 4 menstrual cycles of treatment phase and two follow up phases (first&#xD;
      and third cycle after the treatments were completed). During the treatment phase, the&#xD;
      techniques were applied during 72h in each cycle.&#xD;
&#xD;
      The primary outcome measures were: Mean pain intensity of the 3 first days of bleeding,&#xD;
      maximum pain intensity, number of painful days and dose of drug intake measured with the&#xD;
      Visual Analogue Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blind randomized clinical controlled trial. Participants were randomized to a auricular therapy group, an auricular therapy placebo group, a kinesio tape group, a kinesio tape placebo group and a control group for a 11 month study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The participants in the different intervention groups received real and placebo auricular therapy and kinesio tape treatment.&#xD;
The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area. The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.&#xD;
The outcome assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from the Mean pain intensity</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Mean pain intensity of the 3 first days of menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from the Maximum pain intensity</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Maximum pain intensity during menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from number of painful days</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Count of number of days when the participant experienced pain during the menstruation. A lower number of painful days indicate an improvement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from the dosage of drug intake</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Register of dosage and grug intake of each participant to relief pain during the menstruation. A lower dose of drug intake indicate an improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from the Length of the menstrual cycle</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Count of days that the menstrual cycle lasted for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from the Length of menstruation</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Count of days that menstruation lasted for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from theType of drug</measure>
    <time_frame>Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)</time_frame>
    <description>Record of type of medication used by the participants during the menstruation for pain relief.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Primary Dysmenorrhoea</condition>
  <arm_group>
    <arm_group_label>Auricular therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The auricular therapy group received an intervention based on the bilateral application of 7 adhesive tapes with vaccaria seeds. The points were located with a retractable 250 gr. pressure palpator (Sedatelec®). An experienced health professional trained on acupuncture techniques applied the vaccaria seeds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auricular therapy Placebo group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesio tape group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The kinesio tape group received an intervention that consisted on the standard application of three elastic bandages. An experienced kinesio tape certified physical therapist applied the taping.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kinesio tape Placebo group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group did not receive any treatment. The participants continued with their routine medical treatment. However, the controls completed all the questionnaires to collect the information regarding their symptoms in order to observe their progress with no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Auricular therapy</intervention_name>
    <description>The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen [FT2], uterus [FT5], sympathetic [HI4], kidney [CS6], heart [CI4], endocrine [IT2] and thalamus [PC2].</description>
    <arm_group_label>Auricular therapy group</arm_group_label>
    <other_name>Auricular acupuncture</other_name>
    <other_name>ear therapy</other_name>
    <other_name>auriculotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>kinesio tape</intervention_name>
    <description>Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.</description>
    <arm_group_label>Kinesio tape group</arm_group_label>
    <other_name>medical taping concept</other_name>
    <other_name>neuromuscular taping</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Auricular therapy Placebo group</intervention_name>
    <description>Sham auricular therapy</description>
    <arm_group_label>Auricular therapy Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>kinesio tape Placebo group</intervention_name>
    <description>Sham kinesio tape</description>
    <arm_group_label>kinesio tape Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 18 and 30 years old affected by primary dysmenorrhoea grade 2 and 3 of&#xD;
             Andersch y Milsom classification (Andersch y Milsom, 1982), to have attended&#xD;
             gynaecologist consultation for a general revision in the last 2 years, to have&#xD;
             menstrual pain, to have regular menstrual cycles of 21 to 38 days, to not have an&#xD;
             intrauterine/inter-uterine) device or to be on oral contraceptive treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have been diagnosed with a condition that could influence menstrual pain&#xD;
             perception, to know or have been previously treated with the techniques used in the&#xD;
             interventions and pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with Primary dysmenorrhoea , a pathology that only affects women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Extremadura</name>
      <address>
        <city>Badajoz</city>
        <zip>06011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Extremadura</investigator_affiliation>
    <investigator_full_name>Elisa María Garrido Ardila</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>auricular therapy</keyword>
  <keyword>kinesio tape</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04400968
org study id: 58/2017
nct id: NCT04400968
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study analyse the effectiveness of auricular therapy vs. kinesio tape treatment for pain
      management of women with primary dysmenorrhoea.
Pharmacological treatments are not effective for all women and therefore, the objective of
      this study was to assess and compare the effectiveness of kinesio tape and auricular therapy
      to decrease pain and drug intake in women with primary dysmenorrhoea.

      A randomized controlled trial was conducted. 114 university women from 18 to 30 years old
      were randomized to 5 groups: control, kinesio tape, placebo kinesio tape, auricular therapy
      and placebo auricular therapy. The study was carried out during 4 menstrual cycles of
      pre-treatment phase, 4 menstrual cycles of treatment phase and two follow up phases (first
      and third cycle after the treatments were completed). During the treatment phase, the
      techniques were applied during 72h in each cycle.

      The primary outcome measures were: Mean pain intensity of the 3 first days of bleeding,
      maximum pain intensity, number of painful days and dose of drug intake measured with the
      Visual Analogue Scale.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind randomized clinical controlled trial. Participants were randomized to a auricular therapy group, an auricular therapy placebo group, a kinesio tape group, a kinesio tape placebo group and a control group for a 11 month study.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The participants in the different intervention groups received real and placebo auricular therapy and kinesio tape treatment.
The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area. The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.
The outcome assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.
measure: Changes from the Mean pain intensity
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Mean pain intensity of the 3 first days of menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.
measure: Changes from the Maximum pain intensity
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Maximum pain intensity during menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.
measure: Changes from number of painful days
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Count of number of days when the participant experienced pain during the menstruation. A lower number of painful days indicate an improvement
measure: Changes from the dosage of drug intake
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Register of dosage and grug intake of each participant to relief pain during the menstruation. A lower dose of drug intake indicate an improvement.
measure: Changes from the Length of the menstrual cycle
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Count of days that the menstrual cycle lasted for.
measure: Changes from the Length of menstruation
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Count of days that menstruation lasted for.
measure: Changes from theType of drug
time frame: Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)
description: Record of type of medication used by the participants during the menstruation for pain relief.
arm group label: Auricular therapy group
arm group type: Experimental
description: The auricular therapy group received an intervention based on the bilateral application of 7 adhesive tapes with vaccaria seeds. The points were located with a retractable 250 gr. pressure palpator (Sedatelec®). An experienced health professional trained on acupuncture techniques applied the vaccaria seeds.
arm group label: Auricular therapy Placebo group
arm group type: Sham Comparator
description: The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.
arm group label: Kinesio tape group
arm group type: Experimental
description: The kinesio tape group received an intervention that consisted on the standard application of three elastic bandages. An experienced kinesio tape certified physical therapist applied the taping.
arm group label: kinesio tape Placebo group
arm group type: Sham Comparator
description: The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area.
arm group label: Control group
arm group type: No Intervention
description: The control group did not receive any treatment. The participants continued with their routine medical treatment. However, the controls completed all the questionnaires to collect the information regarding their symptoms in order to observe their progress with no intervention.
intervention type: Procedure
intervention name: Auricular therapy
description: The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen [FT2], uterus [FT5], sympathetic [HI4], kidney [CS6], heart [CI4], endocrine [IT2] and thalamus [PC2].
arm group label: Auricular therapy group
other name: Auricular acupuncture
other name: ear therapy
other name: auriculotherapy
intervention type: Procedure
intervention name: kinesio tape
description: Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.
arm group label: Kinesio tape group
other name: medical taping concept
other name: neuromuscular taping
intervention type: Procedure
intervention name: Auricular therapy Placebo group
description: Sham auricular therapy
arm group label: Auricular therapy Placebo group
intervention type: Procedure
intervention name: kinesio tape Placebo group
description: Sham kinesio tape
arm group label: kinesio tape Placebo group
criteria: 
gender: Female
gender based: Yes
gender description: Women with Primary dysmenorrhoea , a pathology that only affects women
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Extremadura
investigator full name: Elisa María Garrido Ardila
investigator title: PHD
mesh term: Dysmenorrhea
sharing ipd: No