NCT02197429

Brief Summary

A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia. Hypotheses:

  1. 1.Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.
  2. 2.Acupuncture increases sexual function in women with vulvodynia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

July 14, 2014

Last Update Submit

July 18, 2014

Conditions

VulvodyniaVulvar VestibulitisPainDyspareuniaFemale Sexual Dysfunction Due to Physical Condition

Keywords

VulvodyniaAcupunctureProvoked VestibulodyniaVulvar VestibulitisVulvar PainDyspareuniaFemale Sexual Function

Outcome Measures

Primary Outcomes (1)

  • vulvar pain

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

    Baseline and 5 weeks

Secondary Outcomes (1)

  • Dyspareunia

    Baseline and 5 weeks

Other Outcomes (1)

  • Female sexual function

    Baseline and 5 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture

Other: Acupuncture

Wait-list Control

NO INTERVENTION

Wait-list Control

Interventions

AcupunctureOTHER
Acupuncture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glenview Healing Arts

Glenview, Illinois, 60025, United States

Location

Related Publications (4)

  • Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.

    PMID: 24633161BACKGROUND

  • 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.

    PMID: 19912491BACKGROUND

  • 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.

    PMID: 11328221BACKGROUND

  • 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.

    PMID: 22965186BACKGROUND

MeSH Terms

Conditions

VulvodyniaVulvar VestibulitisPainDyspareunia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVulvitisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Judith M. Schlaeger, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 22, 2014

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

US(1)