CClinicalTrials.gg
Sign In
CompletedNCT02197429Updated Jul 22, 2014

Acupuncture for the Treatment of Vulvodynia

An interventional study of Acupuncture in Vulvodynia, Vulvar Vestibulitis and Pain, sponsored by Schlaeger, Judith M., CNM, LAc, PhD. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-22.

Sponsored by Schlaeger, Judith M., CNM, LAc, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • 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
03

In context

Dyspareunia

111 studies on the registry are indexed under Dyspareunia; 33 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 89 interventional studies indexed under Dyspareunia.

Browse Dyspareunia studies →

Lead sponsor

This is the only study on the registry with Schlaeger, Judith M., CNM, LAc, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
  • Provoked vulvodynia
  • Unprovoked vulvodynia
  • Women between 18 years of age and menopause

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Menopause
  • Interstitial cystitis
  • Irritable bowel syndrome
  • Untreated vaginitis
  • Cervicitis
  • Pelvic inflammatory disease
  • Diagnosed with other pelvic pathology causing pain
  • Concomitantly receiving physical therapy
  • Concomitantly receiving biofeedback,
  • Concomitantly receiving massage
  • Concomitantly receiving additional acupuncture.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Acupuncture

    Acupuncture

    Other: Acupuncture

  • No intervention
    Wait-list Control

    Wait-list Control

Interventions

  • OtherAcupuncture
06

What researchers measure

Primary outcomes

  1. vulvar pain

    Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks

    Time frame: Baseline and 5 weeks

Secondary outcomes

  1. Dyspareunia

    Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks

    Time frame: Baseline and 5 weeks

Other outcomes

  1. Female sexual function

    Change from baseline in the total score of the Female Sexual Function Index at 5 weeks

    Time frame: Baseline and 5 weeks

07

Study locations

1 site
  • Glenview Healing Arts
    Glenview, Illinois 60025, United States
08

References and documents

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 24633161 ↗
  • Curran 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 19912491 ↗
  • Danielsson 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 11328221 ↗
  • Vickers 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02197429
Lead sponsor
Schlaeger, Judith M., CNM, LAc, PhD
Responsible party
Sponsor
First posted
Jul 22, 2014
Start date
Feb 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jul 22, 2014

Study contacts

Judith M. Schlaeger, PhD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dyspareunia→

Start the discussion