Effect of Two Acupuncture Protocols on Vulvodynia

NCT03481621 | Unknown DMC FDA Device

• 1 other identifier: McLeanCCAM01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Vulvodynia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Score (Subjective)

  at the end of 6 weeks

• Pain duration

  at the end of 6 weeks

• Intercourse pain

  at the end of 6 weeks

Study Arms (3)

Group1a, Acupuncture on Vulvodynia

ACTIVE COMPARATOR

Focus on using the local points in pudendal nerve distribution area

Device: Acupuncture

Group1b, Acupuncture on Vulvodynia

ACTIVE COMPARATOR

Focus on traditional acupuncture using common meridian or distal points

Device: Acupuncture

Group2, Standard care or waiting lists

ACTIVE COMPARATOR

Standard care without acupuncture

Other: Standard care

Interventions

Acupuncture DEVICE

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).

Also known as: Needling

Group1a, Acupuncture on Vulvodynia; Group1b, Acupuncture on Vulvodynia

Standard care OTHER

PT, pain medications, nerve block, etc

Also known as: Routine treatments

Group2, Standard care or waiting lists

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• McLean Center for Complementary and Alternative Medicine, PLC: lead

Study Sites (1)

McLean Center for Complementary and Alternative Medicine,PLC

Vienna, Virginia, 22182, United States

RECRUITING

Related Publications (1)

• Fan AY, Alemi SF, Zhu YH, Rahimi S, Wei H, Tian H, He D, Gong C, Yang G, He C, Ouyang H. Effectiveness of two different acupuncture strategies in patients with vulvodynia: Study protocol for a pilot pragmatic controlled trial. J Integr Med. 2018 Nov;16(6):384-389. doi: 10.1016/j.joim.2018.10.004. Epub 2018 Oct 10.

  PMID: 30341023 DERIVED

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis

Interventions

Acupuncture Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Arthur Y Fan, MD(CHN),PhD

  McLean Center for Complementary and Alternative Medicine, PLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Y Fan, MD(CHN),PhD

CONTACT

7034994428; ArthurFan@ChineseMedicineDoctor.us

Sarah F Alemi, DAc,LAc

CONTACT

7035478197; ArthurFan@ChineseMedicineDoctor.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will get real treatments, the first group patients will get acupuncture treatments focus on the points within pudendal nerve distribution area; the second group patients will get acupuncture treatments focus on the points from traditional meridian theory. And the third group will get the standard care (no acupuncture). Participants and outcomes assessor will be blinded for the study aims.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Principal Investigator

Model Details: Acupuncture 1: focus on the points within pudendal nerve distribution arae; Acupuncture 2: focus on the points from traditional meridian theory; Standard care: no acupuncture, but use physical therapy, pain medications, nerve blocking, etc.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

US (1)