- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704234
Acupuncture for Vulvodynia: A Pre-pilot Study
Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Wilmette, Illinois, United States, 60098
- A Center for Oriental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Acupuncture
Active Acupuncture 2 times per week for 5 weeks
|
Active Acupuncture two times per week for 5 weeks
Other Names:
|
Placebo Comparator: Placebo
Placebo Acupuncture 2 times per week for 5 weeks
|
Placebo Acupuncture two times per week for 5 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vulvar Pain Scale
Time Frame: baseline and twice weekly for 5 weeks
|
PainReportIt, the computerized McGill Pain Questionnaire
|
baseline and twice weekly for 5 weeks
|
Change in Dyspareunia Questionnaire
Time Frame: baseline and once per week for 5 weeks
|
Female Sexual Function Index
|
baseline and once per week for 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vulvar Function Status Questionnaire
Time Frame: at baseline and 5 weeks
|
Assesses vulvar function
|
at baseline and 5 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality Scale
Time Frame: at baseline and 5 weeks
|
Pittsburgh Sleep Quality Index
|
at baseline and 5 weeks
|
The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture
Time Frame: 5 weeks
|
Acceptability of the acupuncture protocol for the participant
|
5 weeks
|
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
|
5 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: judith schlaeger, PhD, University of Illinois at Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Vulvar Diseases
- Vulvitis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Genital Diseases, Female
- Vulvodynia
- Vulvar Vestibulitis
- Dyspareunia
Other Study ID Numbers
- 2015-0692
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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