Acupuncture for the Treatment of Vulvodynia

NCT ID: NCT02197429

Last Updated: 2014-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vulvodynia Vulvar Vestibulitis Pain Dyspareunia Female Sexual Dysfunction Due to Physical Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Wait-list Control

Wait-list Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Schlaeger, Judith M., CNM, LAc, PhD

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith M. Schlaeger, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Glenview Healing Arts

Glenview, Illinois, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 24633161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19912491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11328221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22965186 (View on PubMed)

Other Identifiers

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11-10-01

Identifier Type: -

Identifier Source: org_study_id

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