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
About this trial
This is an interventional treatment trial for Vestibulodynia
Eligibility Criteria
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
NCT ID
NCT02362763
First Posted
January 28, 2015
Last Updated
February 9, 2015
Sponsor
Hadassah Medical Organization
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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