Acupuncture for the Treatment of Vulvodynia

Pain Clinical Trial

Official title:

Acupuncture for the Treatment of Vulvodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197429
• Other study ID #: 11-10-01
• 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

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

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