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Completed

NCT Number: NCT02704234

Acupuncture for Vulvodynia: A 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active acupuncture

Other

Active Acupuncture two times per week for 5 weeks

Other names: Penetrating Acupuncture Needle

Placebo Acupuncture

Other

Placebo Acupuncture two times per week for 5 weeks

Primary outcomes

  1. Change in Vulvar Pain Scale

    Time frame: baseline and twice weekly for 5 weeks

    PainReportIt, the computerized McGill Pain Questionnaire

  2. Change in Dyspareunia Questionnaire

    Time frame: baseline and once per week for 5 weeks

    Female Sexual Function Index

Secondary outcomes

  1. Vulvar Function Status Questionnaire

    Time frame: at baseline and 5 weeks

    Assesses vulvar function

Other outcomes

  1. Sleep Quality Scale

    Time frame: at baseline and 5 weeks

    Pittsburgh Sleep Quality Index

  2. The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture

    Time frame: 5 weeks

    Acceptability of the acupuncture protocol for the participant

  3. 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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2016
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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