VulvodyniaNCT02704234
Acupuncture for Vulvodynia: A Pre-pilot Study
A study testing Active Acupuncture in people with Vulvodynia and Vulvar Vestibulitis, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vulvodynia, Vulvar Vestibulitis, Dyspareunia
- What is being tested?
- Active Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- women previously diagnosed with generalized vulvodynia
- women previously diagnosed with localized vestibulodynia,
Who cannot join
- pregnancy
- menopause
- interstitial cystitis
- irritable bowel syndrome
- untreated vaginitis
- cervicitis
Show all 12Show fewer
- pelvic inflammatory disease
- any other pelvic pathology causing pain
- concomitant physical therapy
- concomitant biofeedback
- concomitant massage
- additional acupuncture
Trial locations and contacts
1 site in 1 country.
United States1 site
A Center for Oriental Medicine
Wilmette, Illinois, 60098
About this study
Official title: 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.
Read more
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.
- Conditions
- Vulvodynia, Vulvar Vestibulitis, Dyspareunia, Pain
- Being tested
- Active Acupuncture, Placebo Acupuncture
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis, Dyspareunia, Pain
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
Placebo Acupuncture two times per week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Acupuncture | Experimental | Active Acupuncture 2 times per week for 5 weeks Receives: Other: Active Acupuncture |
| Placebo | Placebo comparator | Placebo Acupuncture 2 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.
Change in Vulvar Pain Scale
PainReportIt, the computerized McGill Pain Questionnaire
Measured: baseline and twice weekly for 5 weeks
Change in Dyspareunia Questionnaire
Female Sexual Function Index
Measured: baseline and once per week for 5 weeks
Secondary outcomes (1)
Vulvar Function Status Questionnaire
Assesses vulvar function
Measured: at baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Schlaeger, University of Illinois Chicago
- Investigators
- judith schlaeger, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704234
- Sponsor's protocol ID
- 2015-0692
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2015
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29686883
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
- ClinicalTrials.gov ID
- NCT02704234
- Acronym / sponsor ID
- 2015-0692
- Conditions
- Vulvodynia, Vulvar Vestibulitis, Dyspareunia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Acupuncture | Experimental | Other: Active AcupunctureActive Acupuncture 2 times per week for 5 weeks |
| Placebo | Placebo comparator | Other: Placebo AcupuncturePlacebo Acupuncture 2 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 (2 listed)
- women previously diagnosed with generalized vulvodynia
- women previously diagnosed with localized vestibulodynia,
Key exclusion criteria (12 listed)
- pregnancy
- menopause
- interstitial cystitis
- irritable bowel syndrome
- untreated vaginitis
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 | Active Acupuncture |
| Placebo AcupuncturePlacebo Acupuncture two times per week for 5 weeks | Other | Placebo |
Primary outcome
Change in Vulvar Pain Scale
Time frame: baseline and twice weekly for 5 weeks
PainReportIt, the computerized McGill Pain Questionnaire
Change in Dyspareunia Questionnaire
Time frame: baseline and once per week for 5 weeks
Female Sexual Function Index
1 secondary outcome
Vulvar Function Status Questionnaire
Time frame: at baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 29686883Schlaeger 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.
- Individual participant dataSharing planned: No
Related trials for Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
Active, not recruiting
Lasertherapy for Vulvodynia
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 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 Vulvar Vestibulitis, 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 2 inclusion and 12 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 21 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Vulvar Pain Scale (time frame: baseline and twice weekly for 5 weeks). The study lists 2 primary outcomes in all. 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 NCT02704234, which also lists 1 linked publication.
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 21 Feb 2024.