Acupuncture for Vulvodynia: A Pre-pilot Study

Not Applicable

Completed

• Conditions: Dyspareunia; Pain; Vulvodynia; Vulvar Vestibulitis
• Interventions: Other: Active Acupuncture; Other: Placebo Acupuncture

• Registration Number: NCT02704234
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Study Start: 2018-02-23
• Primary Completion: 2022-10-26
• Study Completion: 2022-11-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Acupuncture	Active Acupuncture	Active Acupuncture 2 times per week for 5 weeks
Placebo	Placebo Acupuncture	Placebo Acupuncture 2 times per week for 5 weeks

Primary Outcome Measures

Name	Time	Method
Change in Dyspareunia Questionnaire	baseline and once per week for 5 weeks	Female Sexual Function Index
Change in Vulvar Pain Scale	baseline and twice weekly for 5 weeks	PainReportIt, the computerized McGill Pain Questionnaire

Secondary Outcome Measures

Name	Time	Method
Vulvar Function Status Questionnaire	at baseline and 5 weeks	Assesses vulvar function

Trial Locations

Locations (1)

A Center for Oriental Medicine; 🇺🇸 Wilmette, Illinois, United States