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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02197429
Other study ID # 11-10-01
Secondary ID
Status Completed
Phase N/A
First received July 14, 2014
Last updated July 18, 2014
Start date February 2012
Est. completion date December 2012

Study information

Verified date July 2014
Source Schlaeger, Judith M., CNM, LAc, PhD
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Acupuncture


Locations

Country Name City State
United States Glenview Healing Arts Glenview Illinois

Sponsors (1)

Lead Sponsor Collaborator
Schlaeger, Judith M., CNM, LAc, PhD

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Danielsson I, Sjöberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41. — View Citation

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

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Female sexual function Change from baseline in the total score of the Female Sexual Function Index at 5 weeks Baseline and 5 weeks No
Primary vulvar pain Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks Baseline and 5 weeks No
Secondary Dyspareunia Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks Baseline and 5 weeks No
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