Acupuncture for Vulvodynia: A Pre-pilot Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704234
• Other study ID #: 2015-0692
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: November 7, 2022

Study information

• Verified date: February 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 7, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia
• Pain
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Other:
• Active Acupuncture
Active Acupuncture two times per week for 5 weeks
• Placebo Acupuncture
Placebo Acupuncture two times per week for 5 weeks

Locations

Country	Name	City	State
United States	A Center for Oriental Medicine	Wilmette	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Quality Scale	Pittsburgh Sleep Quality Index	at baseline and 5 weeks
Other	The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture	Acceptability of the acupuncture protocol for the participant	5 weeks
Other	Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant	Assesses the Ability of the Acupuncturist and Subject to Remain Blind	5 weeks
Primary	Change in Vulvar Pain Scale	PainReportIt, the computerized McGill Pain Questionnaire	baseline and twice weekly for 5 weeks
Primary	Change in Dyspareunia Questionnaire	Female Sexual Function Index	baseline and once per week for 5 weeks
Secondary	Vulvar Function Status Questionnaire	Assesses vulvar function	at baseline and 5 weeks