Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
NCT ID: NCT01996384
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2013-11-30
2016-03-31
Brief Summary
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Detailed Description
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The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Classical Acupuncture + Lidocaine
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Classical Acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Lidocaine
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Non-classical acupuncture + lidocaine
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Non-classical acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Lidocaine
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Interventions
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Classical Acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Non-classical acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Lidocaine
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Reported introital dyspareunia longer than three months duration;
* Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test;
* Able to insert an Original Regular Tampax™ tampon.
Exclusion Criteria
* Pregnant or postpartum and breastfeeding;
* Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed;
* Postmenopausal as defined by surgical or natural menopause (no menses for 12 months);
* Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration;
* Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months).
* Use of SNRIs, lidocaine, or acupuncture within the last three months.
18 Years
45 Years
FEMALE
No
Sponsors
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National Vulvodynia Association
OTHER
Council of Colleges of Acupuncture and Oriental Medicine
UNKNOWN
Oregon Health and Science University
OTHER
Oregon College of Oriental Medicine
OTHER
Responsible Party
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Lee Hullender Rubin, DAOM, LAc
Adjunct Research Faculty
Principal Investigators
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Lee E Hullender Rubin, DAOM
Role: PRINCIPAL_INVESTIGATOR
Oregon College of Oriental Medicine
Locations
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Women's Health Research Unit; Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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Hullender Rubin LE, Mist SD, Schnyer RN, Chao MT, Leclair CM. Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study. J Low Genit Tract Dis. 2019 Oct;23(4):279-286. doi: 10.1097/LGT.0000000000000489.
Related Links
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Other Identifiers
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OHSU IRB 9664
Identifier Type: -
Identifier Source: org_study_id