Effect of Acupuncture on Patient Vulvodynia Outcomes

Study Overview
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Brief Summary
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This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain once a week for up to 12 weeks to see how long the acupuncture effect lasts.

Detailed Description
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The investigators' goal is to demonstrate the effects of acupuncture for the treatment of vulvodynia. Up to 14 million American women have vulvodynia, a debilitating pain syndrome characterized by pain (burning, irritation, stinging or rawness) in the vulva and dyspareunia that renders sexual intercourse virtually impossible and leaves these women desperate for relief. Not only are women in pain, but they often lose their partners or have relationship difficulties due to their inability to have sexual intercourse. No therapies have been proven efficacious and rapid pain relief is unpredictable and rarely possible. After exhausting Western Medicine options, these women often turn to acupuncture. But in contrast to other pain conditions, there have been no acupuncture sham control studies of vulvodynia. Only four studies, including one of the investigators', provide some evidence of the effect of acupuncture on vulvodynia. In three, single-group acupuncture studies, women had less pain, better quality of life, improved sexual health, and improved mental health. The investigators' randomized wait-list controlled pilot study of 36 women with vulvodynia showed great promise. The investigators found a statistically significant and clinically meaningful reduction in vulvar pain and dyspareunia, and an increase in overall sexual function after a 5-week, 13-needle, 10 session acupuncture protocol. This newly developed, standardized acupuncture treatment protocol is the first breakthrough in the treatment of this puzzling disorder. It includes acupuncture points that relieve pain in the genitals. The results of the investigators' initial pilot study provided the first evidence from a two-group design that the acupuncture protocol could reduce pain intensity, pain during intercourse, and increase overall sexual function. These findings, however, warrant stronger evidence to support the inference that the effect is indeed due to the acupuncture since ours or no other study included a sham control or provided follow-up data beyond immediate posttest, which means that the duration of the acupuncture effect is unknown. The investigators' recent feasibility study paves the way to overcome this gap by use of double-blind acupuncture needles. Findings from these two studies support the investigators' proposal for the world's first double-blind randomized controlled trial (RCT) of acupuncture for vulvodynia while exploring its duration of effect. The investigators propose a phase 2 double-blind, pretest/posttest RCT to compare effects of penetrating needles or the skin touch placebo needles on vulvar pain in our 13-needle, 10-session acupuncture treatment protocol. A sample of 130 women, with a diagnosis of vulvodynia, either generalized or provoked vestibulodynia, 18 to 45 years of age will be recruited from clinical and community settings and 80 subjects are expected to complete the study. Stratified by type of vulvodynia, participants will be randomized 1:1 either to the penetrating needle group or the skin touch placebo needle group. These double-blind needles will provide a strong sham procedure to mask both the acupuncturist and subject to the type of needle used for the 10-treatment protocol. Specific aims are to: Aim 1. Compare the penetrating needle group and the skin touch placebo needle group for effects on the: (a) primary outcome: vulvar pain (PAINReportIt® average pain intensity, 0-10), and (b) secondary outcomes: dyspareunia (FSFI dyspareunia) and sexual function (FSFI total). The investigators hypothesize that controlling for baseline values, at posttest there will be statistically significant less vulvar pain (primary) and dyspareunia and better sexual function in the penetrating needle group compared to the skin touch placebo group. Aim 2. In participants with a clinically meaningful reduction in pain intensity (at least 1.5 points) at posttest compared to pretest, describe the duration of the acupuncture treatment and placebo effects weekly until pain returns to pretest or up to 12 weeks after posttest. The investigators will describe the variability over time in vulvar pain intensity (0-10) after a tampon insertion-removal stimulus and thereby explore the duration of the effect by intervention group, vulvodynia subgroups, and demographic subgroups (e.g., age, race, occupation). These findings will provide insights to guide future research on initial and maintenance acupuncture for vulvodynia.

Official Title
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Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes

Conditions
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Vulvodynia, Vulvodynia, Generalized, Vulvar Vestibulitis

Intervention / Treatment
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* Other: Active Acupuncture
* Other: Placebo Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a previous diagnosis of generalized vulvodynia or provoked vestibulodynia 18 to 45 years old a pain now score 4 or higher with tampon insertion and removal performed at the initial screening exam speak and read English Exclusionary Criteria: infectious conditions of the vulva/vagina inflammatory conditions of the vulva/vagina neoplastic disorders of the vulva/vagina neurologic disorders of the vulva/vagina trauma to the genitals iatrogenic conditions of the genitals hormonal deficiencies co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis menopause Patients may have a history of but not have active in the last 6 months migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: Active Acupuncture<br>Active Acupuncture two times per week for 5 weeks | Other: Active Acupuncture<br>* Active Acupuncture two times per week for 5 weeks<br>* Other names: Penetrating Acupuncture Needle;|
| Placebo Comparator: Placebo Acupuncture<br>Placebo Acupuncture two times per week for 5 weeks | Other: Placebo Acupuncture<br>* Placebo Acupuncture two times per week for 5 weeks<br>* Other names: Skin-touch Placebo Needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS). | The subject calls the pain intensity a number between 0 and 10, where 0 is no pain and 10 is pain as bad as it could be. The PINS will include three items (pain now, least and worst pain in the past 24 hours), which are used to calculate the average of pain intensity. The PINS with the three items and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire. | baseline and after the 10th acupuncture treatment week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspareunia Subscale of the Female Sexual Function Index (FSFI) | The FSFI is a 19-item, multi-dimensional, self-report measure that examines six areas of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia. In addition to the six subscale scores, there is a total combined score (FSFIt) that is a measure of overall sexual function. Possible scores range from zero to five for each item and higher scores indicate improved function. | baseline and after the 10th acupuncture treatment week 5 | 
| Total score of the Female Sexual Function Index (FSFI) | The FSFI is a 19-item, multi-dimensional, self-report measure that examines six areas of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia. In addition to the six subscale scores, there is a total combined score (FSFIt) that is a measure of overall sexual function. Possible scores range from zero to five for each item and higher scores indicate improved function. | baseline and after the 10th acupuncture treatment week 5 | 
| Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS). | The subject calls the pain intensity a number between 0 and 10, where 0 is no pain and 10 is pain as bad as it could be. The PINS will include three items (pain now, least and worst pain in the past 24 hours), which are used to calculate the average of pain intensity. The PINS with the three items and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire. | after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar Pain, Dyspareunia