Acupuncture for Vulvodynia: A Pre-pilot Study

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

• Status: Completed
• Conditions: Pain; Vulvodynia; Vulvar Vestibulitis; Dyspareunia
• Intervention / Treatment: Other: Active Acupuncture; Other: Placebo Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Acupuncture; Active Acupuncture 2 times per week for 5 weeks	Other: Active Acupuncture; 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	Other: Placebo Acupuncture; 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	PainReportIt, the computerized McGill Pain Questionnaire	baseline and twice weekly for 5 weeks
Change in Dyspareunia Questionnaire	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	Assesses vulvar function	at baseline and 5 weeks

Other Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Schlaeger JM, Takakura N, Yajima H, Takayama M, Steffen AD, Gabzdyl EM, Nisi RA, McGowan Gruber K, Bussell JM, Wilkie DJ. Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study. Pilot Feasibility Stud. 2018 Apr 13;4:72. doi: 10.1186/s40814-018-0265-9. eCollection 2018.

Study record dates

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

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vulvar Diseases; Vulvitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Vulvodynia; Vulvar Vestibulitis; Dyspareunia
• Other Study ID Numbers: 2015-0692

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