Recruiting

Acupuncture Protocols

Sponsor:

McLean Center for Complementary and Alternative Medicine, PLC

Code:

NCT03481621

Conditions

Vulvodynia

Vulvodynia, Generalized

Vulvar Vestibulitis

Vulvar Pain

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Standard care

Study Details

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 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.

Conditions

Vulvodynia

Vulvodynia, Generalized

Vulvar Vestibulitis

Vulvar Pain

Study ID

NCT03481621

Start date

Jan 1, 2018

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. diagnosis of generalized vulvodynia or provoked vestibulodynia by OB/GYN doctor(s) or pain specialist(s); 18 to 45 years old.
2. Current pain score 4 or higher with tampon insertion and removal performed, or cotton swab test, at the initial screening exam
3. speak and read English or Chinese.

Exclusion Criteria:

1. infectious conditions of the vulvar/vagina;
2. inflammatory conditions of the vulvar/vagina;
3. neoplastic disorders of the vulvar/vagina;
4. neurologic disorders of the vulvar/vagina;
5. acute trauma to the genitals;
6. iatrogenic conditions of the genitals
7. hormonal deficiencies
8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
9. menopause
10. patients have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group1a, Acupuncture on Vulvodynia

Focus on using the local points in pudendal nerve distribution area

active comparator: Group1b, Acupuncture on Vulvodynia

Focus on traditional acupuncture using common meridian or distal points

active comparator: Group2, Standard care or waiting lists

Standard care without acupuncture

Interventions

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).

Standard care

PT, pain medications, nerve block, etc

Primary outcome measure

  • Pain Score (objective) [ Time Frame: at the end of 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

McLean Center for Complementary and Alternative Medicine,PLC

Recruiting

Vienna, Virginia, United States, 22182

Contacts

Principal Investigator:

Arthur Y Fan, MD(CHN), PhD

More Information

Sponsor

McLean Center for Complementary and Alternative Medicine, PLC

Last update posted

Sep 3, 2020

Last verified

Sep, 2020

Keywords

  • Vulvodynia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McLean Center for Complementary and Alternative Medicine, PLC on 2020-09-03.