VulvodyniaNCT02197429
Acupuncture for the Treatment of Vulvodynia
A study testing Acupuncture in people with Vulvodynia and Vulvar Vestibulitis, run by Schlaeger, Judith M., CNM, LAc, PhD at 1 site in United States.
Trial summary
A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia. Hypotheses: 1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia. 2. Acupuncture increases sexual function in women with vulvodynia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia, Vulvar Vestibulitis, Pain
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
- Provoked vulvodynia
- Unprovoked vulvodynia
- Women between 18 years of age and menopause
Who cannot join
- Pregnancy
- Menopause
- Interstitial cystitis
- Irritable bowel syndrome
- Untreated vaginitis
- Cervicitis
Show all 12Show fewer
- Pelvic inflammatory disease
- Diagnosed with other pelvic pathology causing pain
- Concomitantly receiving physical therapy
- Concomitantly receiving biofeedback,
- Concomitantly receiving massage
- Concomitantly receiving additional acupuncture.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia.
Hypotheses:
- Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.
- Acupuncture increases sexual function in women with vulvodynia.
- Conditions
- Vulvodynia, Vulvar Vestibulitis, Pain, Dyspareunia, Female Sexual Dysfunction Due to Physical Condition
- Being tested
- Acupuncture
- Keywords
- Vulvodynia, Acupuncture, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvar Pain, Dyspareunia, Female Sexual Function
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis, Pain, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture Receives: Other: Acupuncture |
| Wait-list Control | No intervention | Wait-list Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
vulvar pain
Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
Measured: Baseline and 5 weeks
Secondary outcomes (1)
Dyspareunia
Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks
Measured: 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 posted22 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schlaeger, Judith M., CNM, LAc, PhD
- Responsible party
- Sponsor
- Investigators
- Judith M. Schlaeger, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197429
- Sponsor's protocol ID
- 11-10-01
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
PubMed 24633161Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.
PubMed 19912491Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.
PubMed 11328221Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PubMed 22965186
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Vulvodynia
- ClinicalTrials.gov ID
- NCT02197429
- Acronym / sponsor ID
- 11-10-01
- Conditions
- Vulvodynia, Vulvar Vestibulitis, Pain, Dyspareunia, Female Sexual Dysfunction Due to Physical Condition
- Keywords
- Vulvodynia, Acupuncture, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvar Pain, Dyspareunia, Female Sexual Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Schlaeger, Judith M., CNM, LAc, PhD
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jul 2014 (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.
A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia.
Hypotheses:
- Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.
- Acupuncture increases sexual function in women with vulvodynia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureAcupuncture |
| Wait-list Control | No intervention | –Wait-list Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
- Provoked vulvodynia
- Unprovoked vulvodynia
- Women between 18 years of age and menopause
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 |
|---|---|---|
| Acupuncture | Other | Acupuncture |
Primary outcome
vulvar pain
Time frame: Baseline and 5 weeks
Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
1 secondary outcome
Dyspareunia
Time frame: 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 22 Jul 2014.
- Background: PubMed 24633161Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
- Background: PubMed 19912491Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.
- Background: PubMed 11328221Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.
- Background: PubMed 22965186Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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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
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Vulvodynia and Vulvar Vestibulitis, run by Schlaeger, Judith M., CNM, LAc, PhD 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 4 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 22 Jul 2014. 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. 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?
vulvar pain (time frame: Baseline and 5 weeks). 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 NCT02197429, which also lists 4 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 22 Jul 2014.