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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03481621
Other study ID # McLeanCCAM01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information

Verified date September 2020
Source McLean Center for Complementary and Alternative Medicine, PLC
Contact Arthur Y Fan, MD(CHN),PhD
Phone 7034994428
Email ArthurFan@ChineseMedicineDoctor.us
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

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Study Design


Intervention

Device:
Acupuncture
Needle size: #32(0.22 mm), 1-1.5 inch(30-40 mm long); Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12 sessions total (in 6 weeks).
Other:
Standard care
PT, pain medications, nerve block, etc

Locations

Country Name City State
United States McLean Center for Complementary and Alternative Medicine,PLC Vienna Virginia

Sponsors (1)

Lead Sponsor Collaborator
McLean Center for Complementary and Alternative Medicine, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Score (objective) Figure out the pain score using Visual Analog pain scale(VAS) using cotton swab , [score 0-no pain, 10-strongest (unbearable) pain]. Expected clinical significant difference (ECSD): 3. at the end of 6 weeks
Secondary Pain Score (Subjective) Figure out the pain score using Visual Analog pain scale(VAS) before use of cotton swab to to test pain , [score 0-no pain, 10-strongest (unbearable) pain]. Expected clinical significant difference (ECSD): 3. at the end of 6 weeks
Secondary Pain duration Monitor the hours of pain per day at the end of 6 weeks
Secondary Intercourse pain Record how much pain during intercourse using Visual Analog pain scale(VAS) [score 0-no pain, 10-strongest] at the end of 6 weeks
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