Acupuncture for Vulvodynia: A Pre-pilot Study

February 20, 2024 updated by: Judith Schlaeger, University of Illinois at Chicago

Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study

Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their genitals between the vagina and labia (lips of the vagina). They also have pain when they have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain, that they cannot have sex.

This research is being done for two reasons. The first reason is to test a set of special needles called double-blinded acupuncture needles to give acupuncture treatments (one is a real needle and the other is a fake needle). The second reason is to develop a protocol (checklist) that will be used in this and future studies, and to identify and resolve any procedural problems. The protocol will be first tested by the principal investigator who is also an acupuncturist. The investigator will perform acupuncture using the protocol, if necessary change the protocol, and then teach a second acupuncturist using the modified protocol how to use the double-blinded acupuncture needles.

The real needle called the penetrating needle penetrates the skin. The fake needle called the non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so it feels like a needle is being inserted. It has a blunt tip.

Participants can't see which needle they are getting acupuncture with because the needles are housed in a double-blinded needle device which has two tubes (an inner and an outer) that neither the acupuncturists nor the participants can see through.

If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used for drug studies to see how well the real medicine works, the investigators can see how effective acupuncture is. The investigators will be testing these needles to treat participants with vulvodynia.

Study Overview

Study Type

Interventional

Enrollment (Actual)

6

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

    • Illinois
      • Wilmette, Illinois, United States, 60098
        • A Center for Oriental Medicine

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women previously diagnosed with generalized vulvodynia
  • women previously diagnosed with localized vestibulodynia,

Exclusion Criteria:

  • pregnancy
  • menopause
  • interstitial cystitis
  • irritable bowel syndrome
  • untreated vaginitis
  • cervicitis
  • pelvic inflammatory disease
  • any other pelvic pathology causing pain
  • concomitant physical therapy
  • concomitant biofeedback
  • concomitant massage
  • 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Acupuncture
Active Acupuncture 2 times per week for 5 weeks
Active Acupuncture two times per week for 5 weeks
Other Names:
  • Penetrating Acupuncture Needle
Placebo Comparator: Placebo
Placebo Acupuncture 2 times per week for 5 weeks
Placebo Acupuncture two times per week for 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vulvar Pain Scale
Time Frame: baseline and twice weekly for 5 weeks
PainReportIt, the computerized McGill Pain Questionnaire
baseline and twice weekly for 5 weeks
Change in Dyspareunia Questionnaire
Time Frame: baseline and once per week for 5 weeks
Female Sexual Function Index
baseline and once per week for 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvar Function Status Questionnaire
Time Frame: at baseline and 5 weeks
Assesses vulvar function
at baseline and 5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality Scale
Time Frame: at baseline and 5 weeks
Pittsburgh Sleep Quality Index
at baseline and 5 weeks
The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture
Time Frame: 5 weeks
Acceptability of the acupuncture protocol for the participant
5 weeks
Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant
Time Frame: 5 weeks
Assesses the Ability of the Acupuncturist and Subject to Remain Blind
5 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: judith schlaeger, PhD, University of Illinois at Chicago

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.

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 (Actual)

February 23, 2018

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

November 7, 2022

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimated)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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