An interventional study of Active Acupuncture and Placebo Acupuncture in Vulvodynia, Vulvodynia, Generalized and Vulvar Vestibulitis, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
Among 47 studies in Vulvodynia with a site in United States — 8 open to participants now, 9 under way, 1 of them phase 3. Vulvodynia · United States.
Among the 47 studies in Vulvodynia with a site in United States, this one is the 7th largest by enrollment of the 36 interventional ones that give a count, is one of 7 that started in 2018, is one of 18 with no phase, and was the 27th registered.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
Browse Vulvodynia studies →8 of the 47 studies in Vulvodynia with a site in United States are open now. Recruiting first, the newest first:
Center for Vulvovaginal Disorders · Sites in United States
University of Miami · Sites in United States
Center for Vulvovaginal Disorders · Sites in United States
Medstar Health Research Institute · Sites in United States
Texas Tech University Health Sciences Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Vulvodynia studies recruiting now, 8 (62%) set no upper age limit and 5 (38%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 5 · Phase 4 2
First in 2002; this study’s year is marked. 7 started in 2018.
This study's enrollment of 89 is above the median of 46 across 89 interventional studies indexed under Vulvodynia.
Median enrollment 45 across the 36 interventional studies, 168 across the 11 observational. Of the 34 that completed or were terminated, 14 (41%) have results posted.
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3 of 47 have an industry lead sponsor. The 10 most frequent:
University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
University of Illinois at Chicago has 2 studies filed under Vulvodynia — fewer than ten, so there is no comparison to draw.
6 of the studies in Vulvodynia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07486830Center for Vulvovaginal DisordersIncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction | 2026-12-20 |
| NCT07401134University of MiamiImproving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery | 2027-01 |
| NCT05343182Oregon Health and Science UniversityVestibulectomy Surgical Techniques Comparison Study | 2027-04 |
| NCT06472765Vaginal Biome ScienceVaginal Ecosystem and Network in the United States Study | 2027-05-15 |
| NCT01829204Texas Tech University Health Sciences CenterProspective Data Bank Creation to Study Vaginal Conditions | 2027-07 |
Among the 47 studies in Vulvodynia with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusionary Criteria:
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.
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Active Acupuncture two times per week for 5 weeks
Other: Active Acupuncture
Placebo Acupuncture two times per week for 5 weeks
Other: Placebo Acupuncture
Active Acupuncture two times per week for 5 weeks
Also known as: Penetrating Acupuncture Needle
Placebo Acupuncture two times per week for 5 weeks
Also known as: Skin-touch Placebo Needle
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
The subject calls the pain intensity a number ranging between the minimum value, 0 and 10, the maximum value. Zero represents "no pain" and 10 represents"pain as bad as it could be". Higher scores mean more pain. 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.
Time frame: baseline and after the 10th acupuncture treatment week 5
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)
The Dyspareunia Subscale of the FSFI measures pain with sexual intercourse. The FSFI consists of three items scored using a scale ranging from zero to five. The scores of the three items are then summed and multiplied by a factor of 0.4, resulting in a minimum score of 0 and a maximum score of 6.0, with higher scores indicating less pain with sexual intercourse.
Time frame: 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 measures overall sexual function from six domains of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia. The six subscale scores are measured on a scale of 0-5 for each item. Individual item responses from each of the 6 domains are added together to achieve a domain score and are each multipled by a factor (desire, 0.6; arousal, 0.3; lubrication, 0.3; orgasm, 0.4; satisfaction, 0.4; and dyspareunia, 0.4). These final domain scores are summed to obtain the Total Score of the FSFI, ranging from 2.0 to 36.0, with higher scores indicating better overall sexual function.
Time frame: baseline and after the 10th acupuncture treatment week 5
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
The subject calls the pain intensity a number between 0, the minimum value and 10, the maximum value. Zero is "no pain" and 10 is "pain as bad as it could be." Higher scores indicate a worse outcome. The PINS will include one item (vulvar pain intensity). The PINS with vulvar pain intensity and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire.
Time frame: after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.
Four-hundred and fifty women were assessed for eligibility of which 290 did not meet eligibility criteria and 71 declined to participate. Eighty-nine participants were enrolled between February 2018 and September 2022. Participants were recruited from community settings as well as from medical clinics throughout the Chicagoland area, from healthcare provider referrals, and from the National Vulvodynia Association website.
| Milestone | Experimental: Active Acupuncture | Placebo Acupuncture |
|---|---|---|
| Started | 45 | 44 |
| Completed | 39 | 42 |
| Not completed | 6 | 2 |
The subject calls the pain intensity a number ranging between the minimum value, 0 and 10, the maximum value. Zero represents "no pain" and 10 represents"pain as bad as it could be". Higher scores mean more pain. 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.
| score on a scale | Experimental: Active Acupuncture | Placebo Acupuncture |
|---|---|---|
| Baseline | 3.90 ± 2.39 | 3.51 ± 2.31 |
| After the 10th acupuncture treatment week 5 | 2.48 ± 2.11 | 2.22 ± 2.09 |
The Dyspareunia Subscale of the FSFI measures pain with sexual intercourse. The FSFI consists of three items scored using a scale ranging from zero to five. The scores of the three items are then summed and multiplied by a factor of 0.4, resulting in a minimum score of 0 and a maximum score of 6.0, with higher scores indicating less pain with sexual intercourse.
| score on a scale | Experimental: Active Acupuncture | Placebo Acupuncture |
|---|---|---|
| Baseline | 1.22 ± 0.89 | 1.38 ± 1.16 |
| after the 10th acupuncture treatment week 5 | 1.61 ± 1.76 | 1.83 ± 1.82 |
The FSFI is a 19-item, multi-dimensional, self-report measure that measures overall sexual function from six domains of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia. The six subscale scores are measured on a scale of 0-5 for each item. Individual item responses from each of the 6 domains are added together to achieve a domain score and are each multipled by a factor (desire, 0.6; arousal, 0.3; lubrication, 0.3; orgasm, 0.4; satisfaction, 0.4; and dyspareunia, 0.4). These final domain scores are summed to obtain the Total Score of the FSFI, ranging from 2.0 to 36.0, with higher scores indicating better overall sexual function.
| score on a scale | Experimental: Active Acupuncture | Placebo Acupuncture |
|---|---|---|
| Baseline | 15.9 ± 7.05 | 17.4 ± 5.92 |
| After the 10th acupuncture treatment week 5 | 17.0 ± 8.29 | 19.3 ± 7.71 |
The subject calls the pain intensity a number between 0, the minimum value and 10, the maximum value. Zero is "no pain" and 10 is "pain as bad as it could be." Higher scores indicate a worse outcome. The PINS will include one item (vulvar pain intensity). The PINS with vulvar pain intensity and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire.
| score on a scale | Experimental: Active Acupuncture/Duration of Effect | Placebo Acupuncture/Duration of Effect |
|---|---|---|
| Week 1 | 4.19 ± 2.33 | 2.60 ± 2.09 |
| Week 2 | 3.37 ± 2.50 | 3.68 ± 2.31 |
| Week 3 | 3.79 ± 2.68 | 3.16 ± 1.98 |
| Week 4 | 3.23 ± 2.09 | 3.23 ± 2.39 |
| Week 5 | 4.55 ± 2.54 | 3.13 ± 1.63 |
| Week 6 | 3.88 ± 2.68 | 3.33 ± 1.78 |
| Week 7 | 3.22 ± 1.99 | 3.84 ± 2.48 |
| Week 8 | 2.67 ± 1.80 | 2.79 ± 1.57 |
| Week 9 | 4.00 ± 2.83 | 2.32 ± 0.99 |
| Week 10 | 3.50 ± 1.78 | 2.77 ± 1.59 |
| Week 11 | 2.89 ± 2.57 | 3.04 ± 1.39 |
| Week 12 | 5.40 ± 2.19 | 2.64 ± 1.22 |
Collected over The specific time period over which adverse event data were collected was 5 weeks, which started at the first acupuncture treatment and was completed after the 10th acupuncture treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Active Acupuncture | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Placebo Acupuncture | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
The analysis population is the same as the population in Participant Flow.
| Age, Continuous(years) | Experimental: Active Acupuncture | Placebo Acupuncture | Total |
|---|---|---|---|
| Mean | 29.0 ± 8.25 | 31.4 ± 8.35 | 30.2 ± 8.34 |
| Sex: Female, Male(Participants) | Experimental: Active Acupuncture | Placebo Acupuncture | Total |
|---|---|---|---|
| Female | 45 | 44 | 89 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Active Acupuncture | Placebo Acupuncture | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 18 |
| Not Hispanic or Latino | 34 | 35 | 69 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Experimental: Active Acupuncture | Placebo Acupuncture | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 31 | 31 | 62 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 6 | 4 | 10 |
| Region of Enrollment(Participants) | Experimental: Active Acupuncture | Placebo Acupuncture | Total |
|---|---|---|---|
| United States | 45 | 44 | 89 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data generated by our research are available from the PI, Judith M. Schlaeger, upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will be available immediately upon release of this ClinicalTrials.gov website for 5 years.
Access criteria: Please email the Principal Investigator: Judith Schlaeger, jschlaeg@uic.edu
Ran from Feb 2018 to primary completion in Oct 2022, 56 months.
Results were first posted in May 2025, 2 years 7 months after primary completion.
Of 32 non-industry interventional studies with no phase under Vulvodynia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 56 months is above that.
Counting every sponsor, half of 32 studies reached it within 36 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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University of Illinois at Chicago →