VulvodyniaNCT03364127
Effect of Acupuncture on Patient Vulvodynia Outcomes
A study testing Active Acupuncture in people with Vulvodynia and Vulvodynia, Generalized, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vulvodynia, Vulvodynia, Generalized, Vulvar Vestibulitis
- What is being tested?
- Active Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Nursing
Chicago, Illinois, 60612
About this study
Official title: Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes
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.
Read the detailed description
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.
- Conditions
- Vulvodynia, Vulvodynia, Generalized, Vulvar Vestibulitis
- Being tested
- Active Acupuncture, Placebo Acupuncture
- Keywords
- Vulvar Pain, Dyspareunia
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AcupunctureOther
Also called Penetrating Acupuncture Needle
Active Acupuncture two times per week for 5 weeks
Placebo AcupunctureOther
Also called Skin-touch Placebo Needle
Placebo Acupuncture two times per week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active Acupuncture | Active comparator | Active Acupuncture two times per week for 5 weeks Receives: Other: Active Acupuncture |
| Placebo Acupuncture | Placebo comparator | Placebo Acupuncture two times per week for 5 weeks Receives: Other: Placebo Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and after the 10th acupuncture treatment week 5
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start23 Feb 2018
- Primary completion26 Oct 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Principal investigator, Judith Schlaeger, University of Illinois Chicago
- Investigators
- Judith M. Schlaeger, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364127
- Sponsor's protocol ID
- 2017-0885
- Status last verified
- May 2025
- First submitted
- 30 Nov 2017
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data generated by our research are available from the PI, Judith M. Schlaeger, upon reasonable request.
Publications
Schlaeger JM, Suarez ML, Glayzer JE, Kobak WH, Meinel M, Steffen AD, Burke LA, Pauls HA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster D, Wilkie DJ. Protocol for double-blind RCT of acupuncture for vulvodynia. Contemp Clin Trials Commun. 2022 Nov 2;30:101029. doi: 10.1016/j.conctc.2022.101029. eCollection 2022 Dec.
PubMed 36387991Desloge AA, Patil CL, Glayzer JE, Suarez ML, Kobak WH, Meinel M, Steffen AD, Burke LA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster DC, Wilkie DJ, Schlaeger JM. Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture. J Integr Complement Med. 2023 Jan;29(1):50-54. doi: 10.1089/jicm.2022.0647. Epub 2022 Sep 21.
PubMed 36130137
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes
- ClinicalTrials.gov ID
- NCT03364127
- Acronym / sponsor ID
- 2017-0885
- Conditions
- Vulvodynia, Vulvodynia, Generalized, Vulvar Vestibulitis
- Keywords
- Vulvar Pain, Dyspareunia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active Acupuncture | Active comparator | Other: Active AcupunctureActive Acupuncture two times per week for 5 weeks |
| Placebo Acupuncture | Placebo comparator | Other: Placebo AcupuncturePlacebo Acupuncture two times per week for 5 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
- infectious conditions of the vulva/vagina
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active AcupunctureAlso: Penetrating Acupuncture NeedleActive Acupuncture two times per week for 5 weeks | Other | Experimental: Active Acupuncture |
| Placebo AcupunctureAlso: Skin-touch Placebo NeedlePlacebo Acupuncture two times per week for 5 weeks | Other | Placebo Acupuncture |
Primary outcome
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Time frame: baseline and after the 10th acupuncture treatment week 5
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.
3 secondary outcomes
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)
Time frame: baseline and after the 10th acupuncture treatment week 5
Total Score of the Female Sexual Function Index (FSFI)
Time frame: baseline and after the 10th acupuncture treatment week 5
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Time frame: after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36387991Schlaeger JM, Suarez ML, Glayzer JE, Kobak WH, Meinel M, Steffen AD, Burke LA, Pauls HA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster D, Wilkie DJ. Protocol for double-blind RCT of acupuncture for vulvodynia. Contemp Clin Trials Commun. 2022 Nov 2;30:101029. doi: 10.1016/j.conctc.2022.101029. eCollection 2022 Dec.
- Derived from this study: PubMed 36130137Desloge AA, Patil CL, Glayzer JE, Suarez ML, Kobak WH, Meinel M, Steffen AD, Burke LA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster DC, Wilkie DJ, Schlaeger JM. Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture. J Integr Complement Med. 2023 Jan;29(1):50-54. doi: 10.1089/jicm.2022.0647. Epub 2022 Sep 21.
- Individual participant dataSharing planned: Yes. The data generated by our research are available from the PI, Judith M. Schlaeger, upon reasonable request.
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Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith M. Schlaeger, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Acupuncture in people with Vulvodynia and Vulvodynia, Generalized, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS). (time frame: baseline and after the 10th acupuncture treatment week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.