Acupuncture for Vulvodynia: A Pre-pilot Study
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|ClinicalTrials.gov Identifier: NCT02704234|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : June 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Vulvodynia Vulvar Vestibulitis Dyspareunia Pain||Other: Active Acupuncture Other: Placebo Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Active Acupuncture
Active Acupuncture 2 times per week for 5 weeks
Other: Active Acupuncture
Active Acupuncture two times per week for 5 weeks
Other Name: Penetrating Acupuncture Needle
Placebo Comparator: Placebo
Placebo Acupuncture 2 times per week for 5 weeks
Other: Placebo Acupuncture
Placebo Acupuncture two times per week for 5 weeks
- Change in Vulvar Pain Scale [ Time Frame: baseline and twice weekly for 5 weeks ]PainReportIt, the computerized McGill Pain Questionnaire
- Change in Dyspareunia Questionnaire [ Time Frame: baseline and once per week for 5 weeks ]Female Sexual Function Index
- Vulvar Function Status Questionnaire [ Time Frame: at baseline and 5 weeks ]Assesses vulvar function
- Sleep Quality Scale [ Time Frame: at baseline and 5 weeks ]Pittsburgh Sleep Quality Index
- The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture [ Time Frame: 5 weeks ]Acceptability of the acupuncture protocol for the participant
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704234
|United States, Illinois|
|A Center for Oriental Medicine|
|Wilmette, Illinois, United States, 60098|
|Principal Investigator:||judith schlaeger, PhD||University of Illinois at Chicago|