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Effect of Two Acupuncture Protocols on Vulvodynia (Acu/Vul-pain)

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ClinicalTrials.gov Identifier: NCT03481621
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Arthur Fan, McLean Center for Complementary and Alternative Medicine, PLC

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.


Condition or disease Intervention/treatment Phase
Vulvodynia Vulvodynia, Generalized Vulvar Vestibulitis Vulvar Pain Device: Acupuncture Other: Standard care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Two Acupuncture Protocols on Vulvodynia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: Group1a, Acupuncture on Vulvodynia
Focus on using the local points in pudendal nerve distribution area
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 Name: Needling

Active Comparator: Group1b, Acupuncture on Vulvodynia
Focus on traditional acupuncture using common meridian or distal points
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 Name: Needling

Active Comparator: Group2, Standard care or waiting lists
Standard care without acupuncture
Other: Standard care
PT, pain medications, nerve block, etc
Other Name: Routine treatments




Primary Outcome Measures :
  1. Pain Score (objective) [ Time Frame: at the end of 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Pain Score (Subjective) [ Time Frame: at the end of 6 weeks ]
    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.

  2. Pain duration [ Time Frame: at the end of 6 weeks ]
    Monitor the hours of pain per day

  3. Intercourse pain [ Time Frame: at the end of 6 weeks ]
    Record how much pain during intercourse using Visual Analog pain scale(VAS) [score 0-no pain, 10-strongest]



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481621


Contacts
Contact: Arthur Y Fan, MD(CHN),PhD 7034994428 ArthurFan@ChineseMedicineDoctor.us
Contact: Sarah F Alemi, DAc,LAc 7035478197 ArthurFan@ChineseMedicineDoctor.us

Locations
United States, Virginia
McLean Center for Complementary and Alternative Medicine,PLC Recruiting
Vienna, Virginia, United States, 22182
Contact: Arthur Y Fan, MD(CHN),PhD    703-499-4428    ArthurFan@ChineseMedicineDoctor.us   
Contact: Sarah F Alemi, DAc,LAc    7035478197 ext Alemi    ArthurFan@ChineseMedicineDoctor.us   
Principal Investigator: Arthur Y Fan, MD(CHN), PhD         
Sub-Investigator: Sarah F Alemi, DAc, LAc         
Sub-Investigator: Yingping H Zhu         
Sub-Investigator: Sudaba Rahimi         
Sponsors and Collaborators
McLean Center for Complementary and Alternative Medicine, PLC
Investigators
Principal Investigator: Arthur Y Fan, MD(CHN),PhD McLean Center for Complementary and Alternative Medicine, PLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur Fan, Director,Principal Investigator, McLean Center for Complementary and Alternative Medicine, PLC
ClinicalTrials.gov Identifier: NCT03481621     History of Changes
Other Study ID Numbers: McLeanCCAM01
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Arthur Fan, McLean Center for Complementary and Alternative Medicine, PLC:
Vulvodynia

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis