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The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Primary Purpose

Vestibulodynia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulodynia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

  • Pregnancy
  • Patient who received other treatment for vestibulodynia in the month preceding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study group

    Controls

    Arm Description

    Subjects received five acupuncture sessions designed to treat pain in the vulvar area

    Controls received five acupuncture sessions designed for sedation

    Outcomes

    Primary Outcome Measures

    Female Sexual Function Index (FSFI) questionnaire

    Secondary Outcome Measures

    Clinical examination
    Visual presence or absence of vestibular erythema

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    February 9, 2015
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02362763
    Brief Title
    The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
    Official Title
    The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.
    Detailed Description
    Patients were randomized to five acupuncture sessions designed to treat pain in the vulvar area (study group), or five acupuncture sessions designed for tranquility (controls). Participants and evaluating gynecologists were blinded to randomization. Participants were examined clinically before treatment and one month after completion of assigned treatment; at both visits they completed the Female Sexual Function Index (FSFI) questionnaire. FSFI scores for pain during intercourse and total score were used to evaluate change. The examining gynecologist evaluated the degree of sensitivity to touch and the degree of local erythema. Response to treatment was evaluated for each group before and after treatment, and for study group compared to the control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibulodynia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Subjects received five acupuncture sessions designed to treat pain in the vulvar area
    Arm Title
    Controls
    Arm Type
    Active Comparator
    Arm Description
    Controls received five acupuncture sessions designed for sedation
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.
    Primary Outcome Measure Information:
    Title
    Female Sexual Function Index (FSFI) questionnaire
    Time Frame
    1 month after completion of the assigned treatment
    Secondary Outcome Measure Information:
    Title
    Clinical examination
    Description
    Visual presence or absence of vestibular erythema
    Time Frame
    1 month after completion of the assigned treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of vestibulodynia Exclusion Criteria: Pregnancy Patient who received other treatment for vestibulodynia in the month preceding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaron Hamani, MD
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

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