Clinical trial NCT02704234: Acupuncture for Vulvodynia: A Pre-pilot Study
Official title: Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Vulvar Vestibulitis
Dyspareunia
Pain
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Vulvar Pain Scale
timeFrame: baseline and twice weekly for 5 weeks
measure: Change in Dyspareunia Questionnaire
timeFrame: baseline and once per week for 5 weeks
Secondary outcomes:
measure: Vulvar Function Status Questionnaire
timeFrame: at baseline and 5 weeks
Other outcomes:
measure: Sleep Quality Scale
timeFrame: at baseline and 5 weeks
measure: The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture
timeFrame: 5 weeks
measure: Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant
timeFrame: 5 weeks
Locations:
city: Wilmette
country: United States
facility: A Center for Oriental Medicine
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: judith schlaeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlaeger JM, Takakura N, Yajima H, Takayama M, Steffen AD, Gabzdyl EM, Nisi RA, McGowan Gruber K, Bussell JM, Wilkie DJ. Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study. Pilot Feasibility Stud. 2018 Apr 13;4:72. doi: 10.1186/s40814-018-0265-9. eCollection 2018.