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The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

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ClinicalTrials.gov Identifier: NCT02362763
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
hamaniHMO, Hadassah Medical Organization

Brief Summary:
Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

Condition or disease Intervention/treatment Phase
Vestibulodynia Procedure: Acupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Study group
Subjects received five acupuncture sessions designed to treat pain in the vulvar area
Procedure: Acupuncture
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.

Active Comparator: Controls
Controls received five acupuncture sessions designed for sedation
Procedure: Acupuncture
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 Measures :
  1. Female Sexual Function Index (FSFI) questionnaire [ Time Frame: 1 month after completion of the assigned treatment ]

Secondary Outcome Measures :
  1. Clinical examination [ Time Frame: 1 month after completion of the assigned treatment ]
    Visual presence or absence of vestibular erythema



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362763


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Yaron Hamani, MD Hadassah Medical Organization

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Responsible Party: hamaniHMO, Dr. Yaron Hamani, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02362763     History of Changes
Other Study ID Numbers: VESTIB-HMO-CTIL
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis