Acupuncture for Vulvodynia: A Pre-pilot Study

NCT02704234 | Completed DMC

• 1 other identifier: 2015-0692
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia; Vulvar Vestibulitis; Dyspareunia; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Vulvar Function Status Questionnaire

  at baseline and 5 weeks

Other Outcomes (3)

• Sleep Quality Scale

  at baseline and 5 weeks

• The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture

  5 weeks

• Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant

  5 weeks

Study Arms (2)

Active Acupuncture

EXPERIMENTAL

Active Acupuncture 2 times per week for 5 weeks

Other: Active Acupuncture

Placebo

PLACEBO COMPARATOR

Placebo Acupuncture 2 times per week for 5 weeks

Other: Placebo Acupuncture

Interventions

Active Acupuncture OTHER

Active Acupuncture two times per week for 5 weeks

Also known as: Penetrating Acupuncture Needle

Active Acupuncture

Placebo Acupuncture OTHER

Placebo Acupuncture two times per week for 5 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

A Center for Oriental Medicine

Wilmette, Illinois, 60098, United States

Location

Related Publications (1)

• 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.

  PMID: 29686883 DERIVED

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis; Dyspareunia; Pain

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• judith schlaeger, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: March 9, 2016
• Study Start: February 23, 2018
• Primary Completion: October 26, 2022
• Study Completion: November 7, 2022
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)