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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704234
Other study ID # 2015-0692
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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