A Center for Oriental Medicine
Wilmette, Illinois, 60098, United States
NCT Number: NCT02704234
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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Notify Me18 year–45 year
Female
Interventional
Not applicable
Wilmette, Illinois, 60098, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active Acupuncture two times per week for 5 weeks
Other names: Penetrating Acupuncture Needle
Placebo Acupuncture two times per week for 5 weeks
Time frame: baseline and twice weekly for 5 weeks
PainReportIt, the computerized McGill Pain Questionnaire
Time frame: baseline and once per week for 5 weeks
Female Sexual Function Index
Time frame: at baseline and 5 weeks
Assesses vulvar function
Time frame: at baseline and 5 weeks
Pittsburgh Sleep Quality Index
Time frame: 5 weeks
Acceptability of the acupuncture protocol for the participant
Time frame: 5 weeks
Assesses the Ability of the Acupuncturist and Subject to Remain Blind
University of Illinois at Chicago
Other
Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
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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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