NCT02362763

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

January 28, 2015

Last Update Submit

February 9, 2015

Conditions

Vestibulodynia

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index (FSFI) questionnaire

    1 month after completion of the assigned treatment

Secondary Outcomes (1)

  • Clinical examination

    1 month after completion of the assigned treatment

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Acupuncture

Controls

ACTIVE COMPARATOR

Controls received five acupuncture sessions designed for sedation

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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.

ControlsStudy group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed diagnosis of vestibulodynia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vulvodynia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yaron Hamani, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yaron Hamani

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 13, 2015

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 13, 2015

Record last verified: 2015-02