An interventional study of Active Acupuncture and Placebo Acupuncture in Vulvodynia, Vulvar Vestibulitis and Dyspareunia, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Basic science
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.
111 studies on the registry are indexed under Dyspareunia; 33 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 89 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active Acupuncture 2 times per week for 5 weeks
Other: Active Acupuncture
Placebo Acupuncture 2 times per week for 5 weeks
Other: Placebo Acupuncture
Active Acupuncture two times per week for 5 weeks
Also known as: Penetrating Acupuncture Needle
Placebo Acupuncture two times per week for 5 weeks
Change in Vulvar Pain Scale
PainReportIt, the computerized McGill Pain Questionnaire
Time frame: baseline and twice weekly for 5 weeks
Change in Dyspareunia Questionnaire
Female Sexual Function Index
Time frame: baseline and once per week for 5 weeks
Vulvar Function Status Questionnaire
Assesses vulvar function
Time frame: at baseline and 5 weeks
Sleep Quality Scale
Pittsburgh Sleep Quality Index
Time frame: at baseline and 5 weeks
The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture
Acceptability of the acupuncture protocol for the participant
Time frame: 5 weeks
Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant
Assesses the Ability of the Acupuncturist and Subject to Remain Blind
Time frame: 5 weeks
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago