Acupuncture for the Treatment of Vulvodynia

July 18, 2014 updated by: Schlaeger, Judith M., CNM, LAc, PhD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60025
        • Glenview Healing Arts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
  • Provoked vulvodynia
  • Unprovoked vulvodynia
  • Women between 18 years of age and menopause

Exclusion Criteria:

  • Pregnancy
  • Menopause
  • Interstitial cystitis
  • Irritable bowel syndrome
  • Untreated vaginitis
  • Cervicitis
  • Pelvic inflammatory disease
  • Diagnosed with other pelvic pathology causing pain
  • Concomitantly receiving physical therapy
  • Concomitantly receiving biofeedback,
  • Concomitantly receiving massage
  • Concomitantly receiving additional acupuncture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Other: Acupuncture
No Intervention: Wait-list Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vulvar pain
Time Frame: Baseline and 5 weeks
Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
Baseline and 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspareunia
Time Frame: Baseline and 5 weeks
Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks
Baseline and 5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female sexual function
Time Frame: Baseline and 5 weeks
Change from baseline in the total score of the Female Sexual Function Index at 5 weeks
Baseline and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schlaeger, Judith M., CNM, LAc, PhD

Investigators

  • Principal Investigator: Judith M. Schlaeger, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-10-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe