Pain Clinical Trial
Official title:
Acupuncture for the Treatment of Vulvodynia
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Glenview Healing Arts | Glenview | Illinois |
Lead Sponsor | Collaborator |
---|---|
Schlaeger, Judith M., CNM, LAc, PhD |
United States,
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
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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