<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/NCT02197429</url>
  </required_header>
  <id_info>
    <org_study_id>11-10-01</org_study_id>
    <nct_id>NCT02197429</nct_id>
  </id_info>
  <brief_title>Acupuncture for the Treatment of Vulvodynia</brief_title>
  <official_title>Acupuncture for the Treatment of Vulvodynia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schlaeger, Judith M., CNM, LAc, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schlaeger, Judith M., CNM, LAc, PhD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture&#xD;
      protocol for the treatment of vulvodynia.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.&#xD;
&#xD;
        2. Acupuncture increases sexual function in women with vulvodynia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>vulvar pain</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspareunia</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Female sexual function</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Change from baseline in the total score of the Female Sexual Function Index at 5 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Vulvodynia</condition>
  <condition>Vulvar Vestibulitis</condition>
  <condition>Pain</condition>
  <condition>Dyspareunia</condition>
  <condition>Female Sexual Dysfunction Due to Physical Condition</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or&#xD;
             both&#xD;
&#xD;
          -  Provoked vulvodynia&#xD;
&#xD;
          -  Unprovoked vulvodynia&#xD;
&#xD;
          -  Women between 18 years of age and menopause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Menopause&#xD;
&#xD;
          -  Interstitial cystitis&#xD;
&#xD;
          -  Irritable bowel syndrome&#xD;
&#xD;
          -  Untreated vaginitis&#xD;
&#xD;
          -  Cervicitis&#xD;
&#xD;
          -  Pelvic inflammatory disease&#xD;
&#xD;
          -  Diagnosed with other pelvic pathology causing pain&#xD;
&#xD;
          -  Concomitantly receiving physical therapy&#xD;
&#xD;
          -  Concomitantly receiving biofeedback,&#xD;
&#xD;
          -  Concomitantly receiving massage&#xD;
&#xD;
          -  Concomitantly receiving additional acupuncture.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judith M. Schlaeger, PhD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Glenview Healing Arts</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.</citation>
    <PMID>24633161</PMID>
  </reference>
  <reference>
    <citation>Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.</citation>
    <PMID>19912491</PMID>
  </reference>
  <reference>
    <citation>Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.</citation>
    <PMID>11328221</PMID>
  </reference>
  <reference>
    <citation>Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.</citation>
    <PMID>22965186</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vulvodynia</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Provoked Vestibulodynia</keyword>
  <keyword>Vulvar Vestibulitis</keyword>
  <keyword>Vulvar Pain</keyword>
  <keyword>Dyspareunia</keyword>
  <keyword>Female Sexual Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspareunia</mesh_term>
    <mesh_term>Vulvodynia</mesh_term>
    <mesh_term>Vulvar Vestibulitis</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/NCT02197429
org study id: 11-10-01
nct id: NCT02197429
lead sponsor: 
has dmc: No
A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture
      protocol for the treatment of vulvodynia.

      Hypotheses:

        1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.

        2. Acupuncture increases sexual function in women with vulvodynia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: vulvar pain
time frame: Baseline and 5 weeks
description: Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
measure: Dyspareunia
time frame: Baseline and 5 weeks
description: Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks
measure: Female sexual function
time frame: Baseline and 5 weeks
description: Change from baseline in the total score of the Female Sexual Function Index at 5 weeks
arm group label: Acupuncture
arm group type: Experimental
description: Acupuncture
arm group label: Wait-list Control
arm group type: No Intervention
description: Wait-list Control
intervention type: Other
intervention name: Acupuncture
arm group label: Acupuncture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith M. Schlaeger, PhD
role: Principal Investigator
facility: 
country: United States
citation: Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
PMID: 24633161
citation: Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.
PMID: 19912491
citation: Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.
PMID: 11328221
citation: Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PMID: 22965186
responsible party type: Sponsor
mesh term: Dyspareunia
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis