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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Acupuncture | Experimental | Active Acupuncture 2 times per week for 5 weeks |
|
| Placebo | Placebo Comparator | Placebo Acupuncture 2 times per week for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Acupuncture | Other | Active Acupuncture two times per week for 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vulvar Pain Scale | PainReportIt, the computerized McGill Pain Questionnaire | baseline and twice weekly for 5 weeks |
| Change in Dyspareunia Questionnaire | Female Sexual Function Index | baseline and once per week for 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vulvar Function Status Questionnaire | Assesses vulvar function | at baseline and 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality Scale | Pittsburgh Sleep Quality Index | at baseline and 5 weeks |
| The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture | Acceptability of the acupuncture protocol for the participant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| judith schlaeger, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A Center for Oriental Medicine | Wilmette | Illinois | 60098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29686883 | Derived | 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. |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D054515 | Vulvar Vestibulitis |
| D004414 | Dyspareunia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo Acupuncture | Other | Placebo Acupuncture two times per week for 5 weeks |
|
| 5 weeks |
| Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant | Assesses the Ability of the Acupuncturist and Subject to Remain Blind | 5 weeks |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014847 | Vulvitis |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |