Vulvodynia Clinical Trial
— Acu/Vul-painOfficial title:
Pilot Clinical Trial of Two Acupuncture Protocols on Vulvodynia
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.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | McLean Center for Complementary and Alternative Medicine,PLC | Vienna | Virginia |
Lead Sponsor | Collaborator |
---|---|
McLean Center for Complementary and Alternative Medicine, PLC |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05478746 -
Effects of Flourish HEC on Localized Provoked Vulvodynia
|
N/A | |
Completed |
NCT02404961 -
Women's Health Study: Immunological Factors and Risk of Vulvodynia
|
||
Completed |
NCT00751010 -
Relationship: Interstitial Cystitis & Vulvodynia-Part 2
|
N/A | |
Completed |
NCT00607490 -
A Randomized Clinical Trial for Women With Vulvodynia
|
N/A | |
Recruiting |
NCT03640624 -
Multidisciplinary Treatment of Chronic Vulvar Pain
|
N/A | |
Recruiting |
NCT05343182 -
Vestibulectomy Surgical Techniques Comparison Study
|
N/A | |
Recruiting |
NCT05518630 -
An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
|
||
Recruiting |
NCT05597358 -
Efficacy of High Intensity Laser for Provoked Vestibulodynia
|
N/A | |
Completed |
NCT01304589 -
Savella in Treatment for Provoked Vestibulodynia
|
Phase 3 | |
Completed |
NCT00590590 -
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
|
Phase 2 | |
Recruiting |
NCT06138171 -
Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
|
||
Completed |
NCT01996384 -
Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
|
Phase 1 | |
Completed |
NCT01664962 -
Search for Genetic Basis of Vulvodynia
|
N/A | |
Recruiting |
NCT05955313 -
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
|
Phase 2 | |
Completed |
NCT02773641 -
Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
|
Phase 3 | |
Completed |
NCT00501774 -
A Search for Helicobacter Pylori in Localized Vulvodynia
|
N/A | |
Completed |
NCT04057755 -
Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
|
Phase 3 | |
Terminated |
NCT04016467 -
Effect of Spinal Manipulation on Vulvar Pain
|
N/A | |
Completed |
NCT01935063 -
Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia
|
N/A | |
Completed |
NCT02809612 -
An Internet-based Information Platform for Vulvodynia Patients
|
N/A |