NCT01996384

Brief Summary

The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

November 18, 2013

Last Update Submit

October 4, 2017

Conditions

Provoked, Localized VulvodyniaProvoked VestibulodyniaVulvar VestibulitisVulvodynia

Keywords

VulvodyniaProvoked, localized vulvodyniavulvar vestibulitisprovoked vestibulodyniavulvovaginal painvulvar painvaginal painchronic painlidocainenumbing agentanesthetic creamacupunctureelectroacupunctureelectrical stimulated acupuncturemanual acupunctureclassical acupuncturenon-classical acupunctureTraditional Chinese MedicineTCMChinese medicineAcupuncture and Oriental MedicineAOMtreatmentfeasibilitypilot studyPatient Reported Outcomes Measure Information SystemTampon Testcotton swab testpain diaryResearch Electronic Data CaptureREDCap

Outcome Measures

Primary Outcomes (1)

  • Tampon Test

    Primary outcome variable will be to measure the change in the reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 12); Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).

    Weeks 1 and 12 study period

Secondary Outcomes (7)

  • Cotton Swab test

    Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.

  • Patient Reported Outcomes Measurement Information System (PROMIS) Scales

    At baseline visit, 6 weeks, 12 weeks, and 24 weeks

  • Satisfaction

    Weeks 12 and 24

  • Expectation

    Week 1

  • Feasibility

    Weeks 12 and 24

  • +2 more secondary outcomes

Other Outcomes (4)

  • Traditional Chinese Medicine (TCM) Diagnosis Category

    Week 1

  • 24-hour mean pain score

    Baseline, Weeks 6, 12, and 24

  • Frequency of intercourse

    Baseline, Weeks 6, 12, and 24

  • +1 more other outcomes

Study Arms (2)

Classical Acupuncture + Lidocaine

EXPERIMENTAL

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).

Procedure: Classical AcupunctureDrug: Lidocaine

Non-classical acupuncture + lidocaine

ACTIVE COMPARATOR

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).

Procedure: Non-classical acupunctureDrug: Lidocaine

Interventions

Classical AcupuncturePROCEDURE

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.

Classical Acupuncture + Lidocaine
Non-classical acupuncturePROCEDURE

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.

Non-classical acupuncture + lidocaine
LidocaineDRUG

Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.

Also known as: 5% Lidocaine cream
Classical Acupuncture + LidocaineNon-classical acupuncture + lidocaine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia
  • 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.

You may not qualify if:

  • Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Research Unit; Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 31592976RESULT

Related Links

MeSH Terms

Conditions

Vulvar VestibulitisVulvodyniaChronic Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

VulvitisVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lee E Hullender Rubin, DAOM

    Oregon College of Oriental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Research Faculty

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 27, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(1)