Effect of Two Acupuncture Protocols on Vulvodynia

Brief Title

Effect of Two Acupuncture Protocols on Vulvodynia

Official Title

Pilot Clinical Trial of Two Acupuncture Protocols on Vulvodynia

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.
    

Detailed Description

      Aims of this study:

        1. Get preliminary data for future larger, randomized- controlled trials.

        2. See whether acupuncture is better than no-acupuncture treatments (where participations
           are following standard care for this condition), or at least have probable better
           outcomes than no acupuncture treatment (there may not be significance in statistics,
           given the small sample in current proposed trial);

        3. See if acupuncture group 1a (with focus on the points in pudendal nerve distribution
           near the pain area) has better results(at least, a trend) than acupuncture group 1b
           (traditional acupuncture focus on meridian or distal points).

      The basic design and interventions:

        1. Diagnosis: Vulvodynia/Vulval pain by gynecologist or pain specialist/doctor, who will
           adopt International diagnose criteria.

        2. Patient sample (estimated): 17 in each acupuncture group (34 total), and 17 patients in
           the no-acupuncture group or standard care waiting list . Total 51 patients;

        3. Groups:

           Group 1a (17 cases): acupuncture, using the local points in pudendal nerve distribution
           area (tender points, and up to two other set of acupuncture points); Group 1b (17
           cases): traditional acupuncture, using common meridian or distal points; Group 2 (17
           cases): standard care, waiting list. This group will receive no acupuncture treatment.

        4. Randomized method: If the patient feels comfortable with acupuncture, they will be
           randomly assigned to either Group 1a or Group1b using randomization numbers generated by
           computer; if the patients still are under the treatments of routine conventional
           treatments, such as using pain medications, local injections, and physical therapies, or
           other non-surgical procedure, they will serve as participants in the standard care
           group, the waiting list.

        5. Blind Method: Patients will be blind as to the purpose of the study as well as to the
           groups that they are assigned too. Each participant in either group 1a or 1b will
           receive actual, real acupuncture treatment but, depending on their group assignment, the
           strategy and points used will vary.

        6. Treatments:

           Group 1a: acupuncture: needling focus on Hui yang, pudendal nerve points and local
           point(s) near the pain location with needling manipulation (such as twisting 200/min for
           2-5 minutes at pudendal nerve points); Group 1b: acupuncture: using meridian points,
           focus on Xue Hai (SP9), San Yin Jiao (SP6), Zu San Li (ST36); Both groups also use: Shen
           Ting (GV24), Tou Wei (ST 8), Yin Tang (EX2) for helping to release stress and create
           calm.

           Both group 1(a/b) and group 2 patients are all allowed to use pain medications (in which
           the medications' name and how many pills used during 6 weeks' observation period will be
           carefully document); the standard care group actually is a waiting list, without
           acupuncture intervention. Follow up: 6 weeks.

           Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12
           sessions (in 6 weeks).

        7. Main observation:

      (1) Objective pain score(tested using cotton swab); (2) Patient self reported pain score
      (subjective, before Cotton swab test); Others: Pain duration and pain score during
      intercourse.

      8. Statistics: student t-test.

      Sample calculation: The expected difference (ECSD) between two means is 3, and the common
      within group standard deviation is 3. Giving an 80 chance that an 0.05 level test of
      significance will find a statistically significant difference between two sample means are
      compared, the sample size is approximately 17 per group.

      Comparisons:

        1. At the end point (end of 6 weeks), make comparisons between acupuncture (1a+1b) group
           and group 2, acupuncture 1a and group 2, acupuncture 1b and group 2; between acupuncture
           1a and acupuncture 1b; respectively.

        2. At the end point (end of 6 weeks), make comparisons in each group self (before and
           after).
    


Study Type

Interventional


Primary Outcome

Pain Score (objective)

Secondary Outcome

 Pain Score (Subjective)

Condition

Vulvodynia

Intervention

Acupuncture

Study Arms / Comparison Groups

 Group1a, Acupuncture on Vulvodynia
Description:  Focus on using the local points in pudendal nerve distribution area

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

51

Start Date

January 1, 2018

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2020

Eligibility 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.
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Arthur Y Fan, MD(CHN),PhD, 7034994428, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03481621

Organization ID

McLeanCCAM01


Responsible Party

Principal Investigator

Study Sponsor

McLean Center for Complementary and Alternative Medicine, PLC


Study Sponsor

Arthur Y Fan, MD(CHN),PhD, Principal Investigator, McLean Center for Complementary and Alternative Medicine, PLC


Verification Date

September 2020