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Classical Acupuncture + Lidocaine for Vulvodynia

Phase 1
Waitlist Available
Led By Lee E Hullender Rubin, DAOM
Research Sponsored by Oregon College of Oriental Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
Awards & highlights

Study 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.

Eligible Conditions
  • Vulvodynia
  • Vulvar Vestibulitis
  • Localized Vulvodynia
  • Provoked Vestibulodynia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Acceptability
Cotton Swab test
Expectation
+4 more
Other outcome measures
24-hour mean pain score
Frequency of intercourse
Intensity of Intercourse pain
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Classical Acupuncture + LidocaineExperimental Treatment2 Interventions
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).
Group II: Non-classical acupuncture + lidocaineActive Control2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved
Classical Acupuncture
2013
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Vulvodynia AssociationOTHER
Council of Colleges of Acupuncture and Oriental MedicineUNKNOWN
Oregon Health and Science UniversityOTHER
984 Previous Clinical Trials
7,385,635 Total Patients Enrolled
3 Trials studying Vulvodynia
195 Patients Enrolled for Vulvodynia
~2 spots leftby Jun 2025