Status:
UNKNOWN
Effect of Two Acupuncture Protocols on Vulvodynia
Lead Sponsor:
McLean Center for Complementary and Alternative Medicine, PLC
Conditions:
Vulvodynia
Vulvodynia, Generalized
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Vulvodynia is a common condition in women (16%); however, at this time there is no known effective non-pharmacological therapy reported. Acupuncture is one complementary and alternative medicine thera...
Detailed Description
Aims of this study: 1. Get preliminary data for future larger, randomized- controlled trials. 2. See whether acupuncture is better than no-acupuncture treatments (where participations are following s...
Eligibility Criteria
Inclusion
- diagnosis of generalized vulvodynia or provoked vestibulodynia by OB/GYN doctor(s) or pain specialist(s); 18 to 45 years old.
- Current pain score 4 or higher with tampon insertion and removal performed, or cotton swab test, at the initial screening exam
- speak and read English or Chinese.
Exclusion
- infectious conditions of the vulvar/vagina;
- inflammatory conditions of the vulvar/vagina;
- neoplastic disorders of the vulvar/vagina;
- neurologic disorders of the vulvar/vagina;
- acute trauma to the genitals;
- iatrogenic conditions of the genitals
- hormonal deficiencies
- co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
- menopause
- patients have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03481621
Start Date
January 1 2018
End Date
December 31 2021
Last Update
September 3 2020
Active Locations (1)
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1
McLean Center for Complementary and Alternative Medicine,PLC
Vienna, Virginia, United States, 22182