Effect of Two Acupuncture Protocols on Vulvodynia
Status unconfirmed · Not applicable
Conditions studied: Vulvodynia, Vulvodynia, Generalized, Vulvar Vestibulitis, Vulvar Pain
In brief
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 therapy used by many patients with vulvodynia; some case reports show that acupuncture may be an effective intervention. In recent years, there were some studies registered took at like at actual trials of acupuncture on vulvodynia, but either they did not reach the trial aims, some studies did not get enough patients or the trial designs mimic drug studies and did not reflect acupuncture real characteristics. This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. One third of the women will receive acupuncture focused on pudendal nerve distribution area; another one third of the women will receive acupuncture focused on traditional meridian points; the other one third of women will use standard care (without acupuncture). Women who get a reduction in pain (included in subjective and objective scores) will have their pain monitored once a week for up to 6 weeks to see if the acupuncture effect lasts.
Key facts
- Study ID
- NCT03481621
- Run by
- McLean Center for Complementary and Alternative Medicine, PLC
- People needed
- 51
- Starts
- 2018-01-01
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2020-09-03
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- McLean Center for Complementary and Alternative Medicine,PLC — Vienna, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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